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    [title] => FDA OKs Beckman Coulter's Early Sepsis Indicator
    [short_title] => 
    [summary] => New hematologic biomarker has the potential to revolutionize clinicians' approach to sepsis triage and diagnosis.
    [slug] => fda-oks-beckman-coulters-early-sepsis-indicator
    [body] => A major milestone on its strategic mission to lead in sepsis diagnostics, Beckman Coulter announced that its Early Sepsis Indicator has received 510(k) clearance from the U.S. Food and Drug Administration. Sepsis is a global healthcare crisis that affects more than 30 million people worldwide.1 The Early Sepsis Indicator is a first-of-its-kind, hematology-based cellular biomarker that is designed to help emergency department physicians identify patients with sepsis or at increased risk of developing sepsis.2
 
As part of the pivotal clinical trial for the Early Sepsis Indicator, findings showed that Beckman Coulter's unique monocyte distribution width (MDW) biomarker best discriminated sepsis from all other conditions when combined with the current standard of care. Dr. Derek Angus, chair of the Department of Critical Care Medicine at UPMC (University of Pittsburgh Medical Center), a collaborator in the study, said that the Early Sepsis Indicator is "a novel feature in that it is exploiting the way in which white blood cell counts are already calculated." Other clinical collaborators in the study commented:
 
"Sepsis is a leading cause of hospital mortality, and our study findings indicate this simple biomarker test improves the detection of sepsis at an early stage when it is most responsive to treatment. It's an important breakthrough and it'll likely make a big impact in the care of sepsis, as it is easy to implement and works best when combined with other widely available sepsis diagnostic tools at the time of the initial hospital encounter."—Elliott Crouser, M.D., principal investigator in the clinical trial, The Ohio State University Wexner Medical Center.
 
"Early antibiotic treatment of sepsis and septic shock leads to improved patient survival. Beckman Coulter's Early Sepsis Indicator helps to identify sepsis patients with proven accuracy, providing the opportunity for clinicians to institute treatment when antibiotics are most effective."—Joseph E. Parrillo, M.D., chair, Heart and Vascular Hospital at Hackensack Meridian Health, Hackensack University Medical Center.
 
The Early Sepsis Indicator is automatically reported as part of a routine complete blood count (CBC) with differential for adult emergency department patients. A positive Early Sepsis Indicator result signals a higher probability of sepsis, enabling physicians to initiate lifesaving treatments faster. Conversely, a negative reading indicates a lower probability of sepsis. Compared to reviewing white blood cell count alone, the Early Sepsis Indicator strengthens a clinician's suspicion of sepsis by 43 percent and, together with clinical signs and symptoms, improves their confidence in helping to rule out sepsis by 63 percent.3
 
"The devastating clinical consequences and financial burden of sepsis are now recognized worldwide," said Peter Soltani, Ph.D., senior vice president and general manager of the hematology business at Beckman Coulter. "We are privileged to provide emergency department personnel and clinical laboratorians the tools and information they need to more efficiently recognize sepsis and make treatment decisions as quickly as possible. Knowing sooner and acting faster is the name of the game in the fight against sepsis, and we believe that the Early Sepsis Indicator has the potential to revolutionize the clinical approach to sepsis triage and diagnosis."
 
The Early Sepsis Indicator can be used in conjunction with Beckman Coulter's patented Multidiscipline Reflex Rules in REMISOL Advance middleware. These reflex rules can create customized, automated reflex panels of Beckman Coulter's industry-leading portfolio of in vitro diagnostic tests in the current sepsis identification and management care pathway across multiple disciplines, including hematology, clinical chemistry, immunoassay, microbiology and urinalysis. The Early Sepsis Indicator is also part of Beckman Coulter's clinically impactful menu that matters which address the most prevalent and costly health conditions.
 
References
1 Sepsis Alliance. "Fact Sheet.2018." Sepsis.org. Accessed 6 Mar. 2019.
2 Within the first 12 hours of hospital admission.
3 Based on findings from pivotal clinical trial - SEPSIS CLINICAL ACCURACY PERFORMANCE ON DXH 800 TEST SUMMARY REPORT (PN C07352) [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-04-18 09:10:00 [updated_at] => 2019-04-18 09:12:14 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["303645","310580","305692","311491","310992","310355","309564","309187","308446","307999","306356","305313","302016","306741","306771","305183","311262","311226","311714","311135","304064","308507","304590"] [is_show_company_name] => [created_at] => 2019-04-18 09:04:55 [contentType] => ContentType Object ( [className] => ContentType [content] => Array ( ) [taxonomy] => Array ( ) [listURL] => [logoUrl] => https: [id] => 2487 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => content_types [tag] => breaking_news [short_tag] => breaking_news [class_name] => [display_view] => [list_view] => [slug] => breaking-news [box_view] => [ignore_flag] => 0 [image_id] => 0 [layout_id] => 0 [formattedTag] => Breaking News ) [viewURL] => /contents/view_breaking-news/2019-04-18/fda-oks-beckman-coulters-early-sepsis-indicator/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302016 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Scott Gottlieb, M.D.","title":"Commissioner, U.S. Food and Drug Administration"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177694 [primary_image_old] => [slider_image_id] => 177694 [banner_image] => 0 [title] => New Efforts to Strengthen FDA’s Expanded Access Program [short_title] => [summary] => EA provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices. [slug] => new-efforts-to-strengthen-fdas-expanded-access-program [body] => Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who are unable to access products through clinical trials. As a cancer survivor, I understand, on a very personal level, that patients who are fighting serious or life-threatening diseases want the flexibility to try new therapeutic approaches, including investigational medical products. This is especially relevant when there’s no other FDA-approved treatment option available to a patient.
 
FDA is deeply committed to facilitating this access, while also protecting patients and helping them to be able to make informed decisions with their physicians. We also take steps to help make sure that such access doesn’t interfere or jeopardize investigational trials that could support a medical product’s development or timely approval for the treatment indication.
 
This is the mission of our Expanded Access (EA) program. EA provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices for serious diseases and immediately life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available. We’re taking new steps to improve this framework.
 
Over the last five years, FDA has authorized more than 9,000 applications across drugs, biologics, and devices through the agency’s expanded access program. Furthermore, we’ve authorized approximately 99 percent of all the requests we have received, across all application types.
 
FDA staff is deeply committed to this program and ensuring that it works quickly and effectively for patients and their physicians. Emergency requests for individual patients are usually granted immediately by phone. Non-emergency requests are generally processed within a few days.
 
Despite the success of the EA program, we recognize that there are opportunities for improvement. We’ve taken steps to expand and update the program over the last year. Many of these changes were made in response to feedback the agency received from stakeholders, as well as input from Congress, on how we can make the program more effective.
 
One improvement FDA made was streamlining the required supporting documentation for expanded access requests submitted by a physician for access to a drug or biological for the treatment of an individual patient. These changes reduced the administrative burden for these physicians. Following these changes, we estimate that it takes about 45 minutes, on average, to complete a patient application form. That form typically requires just one attachment.
 
We also simplified the process for Institutional Review Board (IRB) review. For single patient EA, we’ve modified the IRB review process to permit just one IRB member – the chair or another appropriate person – to concur with the treatment use rather than the entire Board.
 
We also clarified in guidance how we use safety data generated from using an investigational drug or biologic through the EA pathway, recognizing and addressing companies’ concerns that EA-related adverse event data could be used in ways that complicate the review process.
 
As part of FDA’s commitment to continuous operational improvement of the expanded access program, we announced last year that we commissioned an independent assessment of the program. The goals were to better understand the current EA program’s performance and identify ways to improve it. It considered stakeholder perspectives from across the healthcare ecosystem, including patients and their advocates/caregivers, healthcare providers and the health systems that support healthcare providers, payers, IRBs, manufacturers, and FDA staff.
 
I’d like to highlight some of the key findings from this assessment, and how we are addressing the opportunities that we’ve identified as ways to strengthen the expanded access program.
The assessment found overall support for FDA’s program, but as we hoped in pursuing this analysis, also identified new steps we can take to improve upon our efforts.
 
For example, the assessment found that external stakeholders’ overall perceptions of FDA’s expanded access program—and FDA’s role in administering it—are very positive. Stakeholders across the health care system highlighted FDA’s commitment to expediting the review of EA applications, the FDA’s collaborative nature, and our focus on continuous improvement.
 
Physicians with direct experience submitting an EA application to the FDA reported positive impressions of the program. Similarly, patients and their advocates described the program as a crucial route to access investigational therapies when other alternatives have been exhausted.
 
Manufacturers, patient advocates, IRB representatives, and physicians all noted that FDA has taken key steps to reduce the administrative burden associated with submitting requests and recognized our commitment to facilitating medically appropriate access via the EA program.
 
Stakeholders also reported some challenges across the physician and patient journey through the program, that, if properly addressed, could meaningfully enhance the program. This feedback is crucial in our continued efforts to improve the program.
 
We’re already acting on these findings.
 
For one thing, the assessment found that confusion with program navigation, multi-stakeholder coordination, and administrative burden were the most frequently-cited challenges. The assessment recommendations include improving FDA’s public website content and investing in resources to support patient/physician program navigation. These are areas where we’ve already taken steps to improve the program, or where we are working on improvements.
 
For instance, based on the feedback from the assessment, today we announced that FDA’s EA webpages will be updated to improve usability through streamlining of content and a more user-friendly organization. This includes a reduction in duplication, as well as the addition of new pages with commonly requested information, such as forms and keywords.
 
These updates will begin rolling out today and will continue in the future as we identify new opportunities to improve the usability of information on our EA webpages.
 
As part of our recently announced proposed reorganization of the Office of the Commissioner, we intend to formally establish an agency-wide Patient Affairs Staff and Health Care Provider Affairs Program, under the oversight of the Office of Clinical Policy and Programs. This will enhance our engagement with these important external stakeholder groups. The Patient Affairs Staff is already in place and charged with serving as the “home base” and primary point of entry for patients and physicians starting the EA process and navigating them through the steps.
 
Additionally, we’ve established an agency-wide Expanded Access Coordinating Committee, which facilitates cross-Center communication and promotes discussion to rapidly address cross-cutting issues related to expanded access to promote consistency and best practices.
 
FDA is deeply committed to our Expanded Access program and facilitating access to medical products outside of clinical trials when no alternative therapy options are available to patients. And we are deeply committed to continuing to enhance this program going forward.
 
It’s important to note that while expanded access represents FDA’s primary avenue for facilitating access for certain patients to unapproved, investigational treatments, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017,” recently signed into law by the President, represents a separate and distinct pathway. The FDA has established a work group to consider what steps may be required to implement this legislation in a way that advances Congress’ intent to promote access and protect patients. Any work we undertake will build on our long-standing commitments to help patients facing life-threatening diseases or conditions access investigational medicines. As a first step, today we are launching a Right to Try webpage that will assist patients in understanding this alternative pathway.
 
We’re dedicated to making sure that patients facing serious conditions have access to promising investigational medicines. We will continue to take new steps to advance these goals. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-09 09:23:00 [updated_at] => 2018-11-09 09:26:56 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300334","300250","299761","299382","298924","297561","297183","296568","296302","296232","299794","282390","299952","289377","290458","281299","289752","280635","289768"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303645 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Emory Health Sciences","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179136 [primary_image_old] => [slider_image_id] => 179136 [banner_image] => 0 [title] => No Bleeding Required: Anemia Detection via Smartphone [short_title] => [summary] => The app uses photos of fingernails taken on a smartphone to accurately measure hemoglobin. [slug] => no-bleeding-required-anemia-detection-via-smartphone [body] => Biomedical engineers have developed a smartphone app for the non-invasive detection of anemia. Instead of a blood test, the app uses photos of someone's fingernails taken on a smartphone to accurately measure how much hemoglobin is in their blood.
 
The results were published in Nature Communications.
 
"All other 'point-of-care' anemia detection tools require external equipment, and represent trade-offs between invasiveness, cost, and accuracy," said principal investigator Wilbur Lam, M.D., Ph.D. "This is a standalone app whose accuracy is on par with currently available point-of-care tests without the need to draw blood."
 
Lam is associate professor of pediatrics at Emory University School of Medicine, a faculty member in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory, and a clinical hematologist at the Aflac Cancer and Blood Disorders Center of Children's Healthcare of Atlanta.
 
The app is part of the Ph.D. work of former biomedical engineering graduate student Rob Mannino, Ph.D., who was motivated to conduct the research by his own experience living with beta-thalassemia, an inherited blood disorder caused by a mutation in the beta-globin gene.
 
"Treatment for my disease requires monthly blood transfusions," Mannino said. "My doctors would test my hemoglobin levels more if they could, but it's a hassle for me to get to the hospital in between transfusions to receive this blood test. Instead, my doctors currently have to just estimate when I'm going to need a transfusion, based on my hemoglobin level trends."
 
"This whole project couldn't have been done by anyone but Rob," Lam said. "He took pictures of himself before and after transfusions as his hemoglobin levels were changing, which enabled him to constantly refine and tweak his technology on himself in a very efficient manner. So essentially, he was his own perfect initial test subject with each iteration of the app."
 
Mannino and Lam say that their app could facilitate self-management by patients with chronic anemia, allowing them to monitor their disease and to identify the times when they need to adjust their therapies or receive transfusions, possibly reducing side effects or complications of having transfusions too early or too late.
 
The researchers say that the app should be used for screening, not clinical diagnosis. The technology could be used by anyone at any time and could be especially appropriate for pregnant women, women with abnormal menstrual bleeding, or runners/athletes. Its simplicity means it could be useful in developing countries. Clinical diagnostic tools have strict accuracy requirements, but Mannino and Lam think that with additional research, they can eventually achieve the accuracy needed to replace blood-based anemia testing for clinical diagnosis.
 
Anemia is a blood condition that affects two billion people worldwide and can lead to fatigue, paleness and cardiac distress if left untreated. The current gold standard for anemia diagnosis is known as a complete blood count (CBC).
 
The researchers studied fingernail photos and correlated the color of the fingernail beds with hemoglobin levels measured by CBC in 337 people: some healthy, and others with a variety of anemia diagnoses. The algorithm for converting fingernail color to blood hemoglobin level was developed with 237 of these subjects and then tested on 100.
 
A single smartphone image, without personalized calibration, can measure hemoglobin level with an accuracy of 2.4 grams/deciliter with a sensitivity of up to 97 percent. Personalized calibration, tested on four patients over the course of several weeks, can improve the accuracy to 0.92 grams/deciliter, a degree of accuracy on par with point-of-care blood-based hemoglobin tests. Normal values are 13.5-17.5 grams/deciliter for males and 12.0-15.5 grams/deciliter for females.
 
In the app, the use of fingernail beds, which do not contain melanin, means the test can be valid for people with a variety of skin tones. The accuracy is consistent for dark or light skin tones, Mannino said. The app uses image metadata to correct for background brightness and can be adapted to phones from multiple manufacturers.
 
Mannino and Lam say they are working with a variety of doctors at Emory and Children's—geriatric, internal medicine, neonatologists, transfusion medicine, global health—to obtain additional data and better calibrate their system.
 
"This is just a snapshot of the accuracy right now," Lam said. "The algorithm gets smarter with every patient enrolled."
 
The research was supported by the National Science Foundation (Graduate Research Fellowship DGE-1650044 and Southeastern Nanotechnology Infrastructure Corridor 1542174), the 2017 Massachusetts General Hospital Primary Care Technology Prize, and National Institutes of Health (R21 EB025646).
 
The smartphone anemia app is projected to be available commercially for public download as soon as Spring of 2019.
 
A patent application has been filed for the anemia app, and Wilbur Lam and Rob Mannino have a financial interest in the success of this product. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-05 10:20:00 [updated_at] => 2018-12-05 10:28:00 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300574","302606","300280","299201","298545","291340","299129","296051","300189","282914","294234","302074","291642","284484","300282","300327","284483","301664","302195","299755","289715","284485","287547","303301"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304064 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179434 [primary_image_old] => [slider_image_id] => 179434 [banner_image] => 0 [title] => AVITA Medical Begins Clinical Study of RECELL System in Pediatric Burn Treatment [short_title] => [summary] => Randomized controlled study is being conducted in Brisbane, Australia. [slug] => avita-medical-begins-clinical-study-of-recell-system-in-pediatric-burn-treatment [body] => AVITA Medical, a global regenerative medicine company, has begun a randomized, controlled clinical study of the RECELL Autologous Cell Harvesting Device (RECELL System) in the treatment of significant superficial partial- and mid-thickness pediatric burns, including scald injuries. The clinical trial is being conducted by the Queensland University of Technology (QUT) in collaboration with the Pegg Leditschke Children’s Burns Centre at Lady Cilento Children’s Hospital in Brisbane, QLD. Treatment of children in the trial has started. The pediatric clinical trial is being led Dr. Bronwyn Griffin, Child Health Research Centre, QUT, and Professor Roy M. Kimble, Lady Cilento Children’s Hospital - Department of Paediatric Surgery.
 
The protocol for the clinical trial was recently presented at the Australian & New Zealand Burn Association Annual Scientific Meeting in Brisbane, Australia, by Dr. Anjana Bairagi, Honorary Research Fellow (Paediatric Surgery) at the Children’s Burns Centre at Lady Cilento Children’s Hospital. The current standard of care for children with partial-thickness burns is cleaning of the wound followed by a dressing application. Limitations of the standard of care include delay in healing of the burn injury, scarring, and pain. The clinical trial will include approximately 90 patients under 18 years old. Patients will be randomized into one of three groups and will be treated either with the RECELL System and Biobrane dressing, the Biobrane dressing alone, or standard care (silver impregnated silicone lined dressing). The primary endpoint will be days to re-epithelization of the burn injury. Secondary endpoints include pain, patient satisfaction and scarring.
 
The RECELL System uses a small amount of a patient’s own skin to prepare Spray-On Skin Cells at the point of care in as little as 30 minutes, providing a new way to treat thermal burns. A small skin sample is enzymatically and mechanically processed in the RECELL System at the point of care to isolate the skin cells to produce a suspension of Spray-On Skin Cells. The regenerative cell suspension includes keratinocytes, fibroblasts, and melanocytes, which play a critical role in wound healing. The suspension can be sprayed directly on a second degree burn or with an expanded skin graft on a third-degree burn, allowing for broad and even distribution of live cells across the entire wound bed. The RECELL System can be used to prepare enough suspension to treat a wound up to 80 times the size of the donor skin sample, so a skin sample approximately the size of a credit card can be used to treat a wound that covers an adult patient’s entire back. Randomized, controlled trials have demonstrated that treatment of acute burn wounds with the RECELL System requires substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment.
 
AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES), an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.
 
AVITA Medical’s first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration in September 2018. The RECELL System indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System produces Spray-On Skin Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 7,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings.

In international markets outside of Europe, the company's portfolio is marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia, and CFDA-cleared in China.
 
In Europe, AVITA Medical's portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. The RECELL Autologous Cell Harvesting Device is designed for the treatment of burns and plastic reconstructive procedures; REGENERCELL Autologous Cell Harvesting Device has been formulated for chronic wounds including leg and foot ulcers; and RENOVACELL Autologous Cell Harvesting Device is tailored for aesthetic applications including the restoration of pigmentation. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-11 09:00:00 [updated_at] => 2018-12-11 09:07:34 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300774","291499","294194","302016","300250","302305","283697","302922","296562","284246","303313","299802","304100","289788","290009","289761","289767","303988","287668","299650"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304590 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179827 [primary_image_old] => [slider_image_id] => 179827 [banner_image] => 0 [title] => Study: Unloading the Left Ventricle 30 Minutes Before Reperfusion in Heart Attack Patients is Safe [short_title] => [summary] => Abiomed is initiating pivotal randomized controlled trial with the FDA. [slug] => study-unloading-the-left-ventricle-30-minutes-before-reperfusion-in-heart-attack-patients-is-safe [body] => Abiomed has announced the results of the U.S. Food and Drug Administration (FDA) STEMI Door-to-Unloading safety and feasibility randomized controlled trial, which show unloading the left ventricle with Impella CP for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock is safe and feasible, when compared to Impella patients reperfused immediately.
 
The results of the prospective, 50 patient, randomized, multi-center trial were recently presented by Navin Kapur, M.D., executive director of the CardioVascular Center for Research and Innovation at Tufts Medical Center, and simultaneously published in Circulation. Dr. Kapur and William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, Mich., are co-principle investigators of the study.
 
The study found:
“If a reduction of infarct size from unloading before reperfusion is confirmed in a future trial, this concept would enhance the existing guidelines of immediate reperfusion for STEMI patients,” said Dr. Kapur. “Seventy-five percent of patients experiencing their first heart attack will develop heart failure within five years, so new approaches are needed to reduce infarct size and prevent heart failure. Pre-clinical non-human data sets show unloading the left ventricle prior to reperfusion activates a cardioprotective program that reduces reperfusion injury, and could improve the current standard of care.”
 
Abiomed also announces that, in agreement with the FDA, it will move forward with a pivotal, multi-center, prospective, randomized controlled trial comparing unloading with delayed reperfusion to the current standard of care (immediate reperfusion without Impella). The pivotal trial is planned to begin next year.
 
“This safety and feasibility study gives us hope that we can help STEMI heart attack patients in the future by unloading the heart muscle with delayed revascularization. The planned pivotal randomized controlled trial will further examine whether unloading with Impella CP for 30 minutes prior to reperfusion will potentially slow down or avoid the development of heart failure,” said Dr. O’Neill.
 
“We would like to thank the FDA, our dedicated employees, the patients who consented and all the investigators for their efforts to successfully complete this milestone. We look forward to the pivotal study and expanding the clinical science for the field of heart recovery," said Michael R. Minogue, chairman, president, and CEO of Abiomed.
 
The safety and feasibility study design was approved by the FDA, with an independent steering committee and data and safety monitor overseeing the trial and a blinded clinical events committee independently adjudicating study endpoints. Infarct size was evaluated using a cardiac magnetic resonance imaging technique assessed at a blinded core lab. The trial was sponsored by Abiomed.
 
Impella heart pumps are not FDA approved for use in STEMI patients without cardiogenic shock.
 
STEMI is a type of heart attack caused by a blockage in one of the main heart arteries, preventing the flow of oxygen to the heart. It is estimated that 965,000 people a year have heart attacks,1 of which approximately 200,000 are classified as STEMI.2 The current standard of care is sometimes called Door-to-Balloon "DTB", for the goal of minimizing the time it takes an interventional cardiologist to deploy an angioplasty balloon to open the patient’s blocked artery. The recommended treatment in guidelines for STEMI is revascularization (opening the blocked artery) to restore blood flow and oxygen supply to the heart muscle through primary percutaneous coronary intervention (PCI) within 90 minutes or less from the time of first medical contact. I

The Impella 2.5 and Impella CP devices are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD are FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.
 
Based in Danvers, Mass., Abiomed, Inc. is a provider of medical devices that provide circulatory support. Its products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart.

References
1. "Heart Disease and Stroke Statistics 2016 Update: A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee." (Circulation. 2016; 133(4); 38-360).
2. "Recent Trends in the Incidence, Treatment, and Outcomes of Patients with ST and Non-ST-Segment Acute Myocardial Infarction," (Am. J. Med. 2011; 124(1); 40—47). [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-26 03:00:00 [updated_at] => 2018-12-20 08:02:42 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["304175","299793","299872","302199","298415","302016","300250","302305","302922","296562","304399","284246","303313","299802","304100"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 305183 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2585 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 180297 [primary_image_old] => [slider_image_id] => 180297 [banner_image] => 0 [title] => Baxter Begins U.S. Trial for On-Demand Peritoneal Dialysis Solution System [short_title] => [summary] => The system is designed to improve home dialysis experience and simplify therapy management. [slug] => baxter-begins-us-trial-for-on-demand-peritoneal-dialysis-solution-system [body] => Baxter International Inc., a global innovator in renal care, announced that the first patients have been enrolled in a U.S. clinical trial for the company’s on-demand peritoneal dialysis (PD) solution generation system. The innovative system is designed to improve the patient experience by making PD solutions in small batches in the patient’s home. The Food and Drug Administration (FDA) has indicated that the company may proceed with the prospective, multi-center clinical trial.
 
“We are on a journey to transform how kidney disease is identified, managed and treated, with a focus on improving outcomes for patients,” said Laura Angelini, general manager of Baxter’s Renal Care business. “Our on-demand technology is the cornerstone of our innovation pipeline, as we believe the technology will open up new possibilities for therapy delivery while improving the experience for patients today.”
 
The system brings together Baxter’s pioneering innovations in home dialysis, industry-leading drug delivery technology and expertise in water filtration systems. The on-demand technology uses a small water filtration device, concentrates, and Baxter’s Amia automated peritoneal dialysis system to turn the patient’s tap water into dialysis solution, as it is needed to complete each therapy session.
 
Today, patients receive up to 40 boxes of pre-made dialysis solution every four weeks, weighing in at more than 900 pounds on average. These boxes take up a lot of space in a patient’s home, often filling a closet or spare bedroom. Making solution on demand allows Baxter to improve the PD experience by eliminating heavy, six-liter bags that patients must carry around their homes while setting up therapy. On-demand solutions may also drastically reduce the storage space patients need. Because the concentrate bags are smaller and can be used for several dialysis sessions, patients may also be able to reduce the amount of plastic and cardboard they recycle and dispose of daily.
 
The innovative system is designed to be more flexible to meet individual patient needs while simplifying how clinicians manage therapy for their patients. PD solutions are available in different concentrations of glucose, with higher concentrations removing more fluid and waste than lower concentrations. Making solutions on demand means that a physician could add or change the concentrations being used in therapy in near real-time, through Baxter’s Sharesource remote patient management system. The flexibility to adapt therapy would be a significant improvement from current practice, where a clinician manually creates a new prescription, places an order for pre-made solutions and waits for delivery, or keeps even more boxes of solutions on-hand in patients’ homes.
 
The clinical trial assesses the efficacy and safety of the system, with each participant using the new system for 12 weeks. Following conclusion of the trial and study reporting process, Baxter expects to submit a New Drug Application (NDA) for the concentrates and 510(k) for the device to the FDA.
 
Baxter’s on-demand solution technology is an investigative product and not approved for use. Amia with Sharesource is by Rx Only. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-07 08:21:00 [updated_at] => 2019-01-08 09:20:33 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["301035","290592","299201","301638","289768","305196","289744","289761"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302016 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Scott Gottlieb, M.D.","title":"Commissioner, U.S. Food and Drug Administration"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177694 [primary_image_old] => [slider_image_id] => 177694 [banner_image] => 0 [title] => New Efforts to Strengthen FDA’s Expanded Access Program [short_title] => [summary] => EA provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices. [slug] => new-efforts-to-strengthen-fdas-expanded-access-program [body] => Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who are unable to access products through clinical trials. As a cancer survivor, I understand, on a very personal level, that patients who are fighting serious or life-threatening diseases want the flexibility to try new therapeutic approaches, including investigational medical products. This is especially relevant when there’s no other FDA-approved treatment option available to a patient.
 
FDA is deeply committed to facilitating this access, while also protecting patients and helping them to be able to make informed decisions with their physicians. We also take steps to help make sure that such access doesn’t interfere or jeopardize investigational trials that could support a medical product’s development or timely approval for the treatment indication.
 
This is the mission of our Expanded Access (EA) program. EA provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices for serious diseases and immediately life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available. We’re taking new steps to improve this framework.
 
Over the last five years, FDA has authorized more than 9,000 applications across drugs, biologics, and devices through the agency’s expanded access program. Furthermore, we’ve authorized approximately 99 percent of all the requests we have received, across all application types.
 
FDA staff is deeply committed to this program and ensuring that it works quickly and effectively for patients and their physicians. Emergency requests for individual patients are usually granted immediately by phone. Non-emergency requests are generally processed within a few days.
 
Despite the success of the EA program, we recognize that there are opportunities for improvement. We’ve taken steps to expand and update the program over the last year. Many of these changes were made in response to feedback the agency received from stakeholders, as well as input from Congress, on how we can make the program more effective.
 
One improvement FDA made was streamlining the required supporting documentation for expanded access requests submitted by a physician for access to a drug or biological for the treatment of an individual patient. These changes reduced the administrative burden for these physicians. Following these changes, we estimate that it takes about 45 minutes, on average, to complete a patient application form. That form typically requires just one attachment.
 
We also simplified the process for Institutional Review Board (IRB) review. For single patient EA, we’ve modified the IRB review process to permit just one IRB member – the chair or another appropriate person – to concur with the treatment use rather than the entire Board.
 
We also clarified in guidance how we use safety data generated from using an investigational drug or biologic through the EA pathway, recognizing and addressing companies’ concerns that EA-related adverse event data could be used in ways that complicate the review process.
 
As part of FDA’s commitment to continuous operational improvement of the expanded access program, we announced last year that we commissioned an independent assessment of the program. The goals were to better understand the current EA program’s performance and identify ways to improve it. It considered stakeholder perspectives from across the healthcare ecosystem, including patients and their advocates/caregivers, healthcare providers and the health systems that support healthcare providers, payers, IRBs, manufacturers, and FDA staff.
 
I’d like to highlight some of the key findings from this assessment, and how we are addressing the opportunities that we’ve identified as ways to strengthen the expanded access program.
The assessment found overall support for FDA’s program, but as we hoped in pursuing this analysis, also identified new steps we can take to improve upon our efforts.
 
For example, the assessment found that external stakeholders’ overall perceptions of FDA’s expanded access program—and FDA’s role in administering it—are very positive. Stakeholders across the health care system highlighted FDA’s commitment to expediting the review of EA applications, the FDA’s collaborative nature, and our focus on continuous improvement.
 
Physicians with direct experience submitting an EA application to the FDA reported positive impressions of the program. Similarly, patients and their advocates described the program as a crucial route to access investigational therapies when other alternatives have been exhausted.
 
Manufacturers, patient advocates, IRB representatives, and physicians all noted that FDA has taken key steps to reduce the administrative burden associated with submitting requests and recognized our commitment to facilitating medically appropriate access via the EA program.
 
Stakeholders also reported some challenges across the physician and patient journey through the program, that, if properly addressed, could meaningfully enhance the program. This feedback is crucial in our continued efforts to improve the program.
 
We’re already acting on these findings.
 
For one thing, the assessment found that confusion with program navigation, multi-stakeholder coordination, and administrative burden were the most frequently-cited challenges. The assessment recommendations include improving FDA’s public website content and investing in resources to support patient/physician program navigation. These are areas where we’ve already taken steps to improve the program, or where we are working on improvements.
 
For instance, based on the feedback from the assessment, today we announced that FDA’s EA webpages will be updated to improve usability through streamlining of content and a more user-friendly organization. This includes a reduction in duplication, as well as the addition of new pages with commonly requested information, such as forms and keywords.
 
These updates will begin rolling out today and will continue in the future as we identify new opportunities to improve the usability of information on our EA webpages.
 
As part of our recently announced proposed reorganization of the Office of the Commissioner, we intend to formally establish an agency-wide Patient Affairs Staff and Health Care Provider Affairs Program, under the oversight of the Office of Clinical Policy and Programs. This will enhance our engagement with these important external stakeholder groups. The Patient Affairs Staff is already in place and charged with serving as the “home base” and primary point of entry for patients and physicians starting the EA process and navigating them through the steps.
 
Additionally, we’ve established an agency-wide Expanded Access Coordinating Committee, which facilitates cross-Center communication and promotes discussion to rapidly address cross-cutting issues related to expanded access to promote consistency and best practices.
 
FDA is deeply committed to our Expanded Access program and facilitating access to medical products outside of clinical trials when no alternative therapy options are available to patients. And we are deeply committed to continuing to enhance this program going forward.
 
It’s important to note that while expanded access represents FDA’s primary avenue for facilitating access for certain patients to unapproved, investigational treatments, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017,” recently signed into law by the President, represents a separate and distinct pathway. The FDA has established a work group to consider what steps may be required to implement this legislation in a way that advances Congress’ intent to promote access and protect patients. Any work we undertake will build on our long-standing commitments to help patients facing life-threatening diseases or conditions access investigational medicines. As a first step, today we are launching a Right to Try webpage that will assist patients in understanding this alternative pathway.
 
We’re dedicated to making sure that patients facing serious conditions have access to promising investigational medicines. We will continue to take new steps to advance these goals. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-09 09:23:00 [updated_at] => 2018-11-09 09:26:56 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300334","300250","299761","299382","298924","297561","297183","296568","296302","296232","299794","282390","299952","289377","290458","281299","289752","280635","289768"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303645 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Emory Health Sciences","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179136 [primary_image_old] => [slider_image_id] => 179136 [banner_image] => 0 [title] => No Bleeding Required: Anemia Detection via Smartphone [short_title] => [summary] => The app uses photos of fingernails taken on a smartphone to accurately measure hemoglobin. [slug] => no-bleeding-required-anemia-detection-via-smartphone [body] => Biomedical engineers have developed a smartphone app for the non-invasive detection of anemia. Instead of a blood test, the app uses photos of someone's fingernails taken on a smartphone to accurately measure how much hemoglobin is in their blood.
 
The results were published in Nature Communications.
 
"All other 'point-of-care' anemia detection tools require external equipment, and represent trade-offs between invasiveness, cost, and accuracy," said principal investigator Wilbur Lam, M.D., Ph.D. "This is a standalone app whose accuracy is on par with currently available point-of-care tests without the need to draw blood."
 
Lam is associate professor of pediatrics at Emory University School of Medicine, a faculty member in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory, and a clinical hematologist at the Aflac Cancer and Blood Disorders Center of Children's Healthcare of Atlanta.
 
The app is part of the Ph.D. work of former biomedical engineering graduate student Rob Mannino, Ph.D., who was motivated to conduct the research by his own experience living with beta-thalassemia, an inherited blood disorder caused by a mutation in the beta-globin gene.
 
"Treatment for my disease requires monthly blood transfusions," Mannino said. "My doctors would test my hemoglobin levels more if they could, but it's a hassle for me to get to the hospital in between transfusions to receive this blood test. Instead, my doctors currently have to just estimate when I'm going to need a transfusion, based on my hemoglobin level trends."
 
"This whole project couldn't have been done by anyone but Rob," Lam said. "He took pictures of himself before and after transfusions as his hemoglobin levels were changing, which enabled him to constantly refine and tweak his technology on himself in a very efficient manner. So essentially, he was his own perfect initial test subject with each iteration of the app."
 
Mannino and Lam say that their app could facilitate self-management by patients with chronic anemia, allowing them to monitor their disease and to identify the times when they need to adjust their therapies or receive transfusions, possibly reducing side effects or complications of having transfusions too early or too late.
 
The researchers say that the app should be used for screening, not clinical diagnosis. The technology could be used by anyone at any time and could be especially appropriate for pregnant women, women with abnormal menstrual bleeding, or runners/athletes. Its simplicity means it could be useful in developing countries. Clinical diagnostic tools have strict accuracy requirements, but Mannino and Lam think that with additional research, they can eventually achieve the accuracy needed to replace blood-based anemia testing for clinical diagnosis.
 
Anemia is a blood condition that affects two billion people worldwide and can lead to fatigue, paleness and cardiac distress if left untreated. The current gold standard for anemia diagnosis is known as a complete blood count (CBC).
 
The researchers studied fingernail photos and correlated the color of the fingernail beds with hemoglobin levels measured by CBC in 337 people: some healthy, and others with a variety of anemia diagnoses. The algorithm for converting fingernail color to blood hemoglobin level was developed with 237 of these subjects and then tested on 100.
 
A single smartphone image, without personalized calibration, can measure hemoglobin level with an accuracy of 2.4 grams/deciliter with a sensitivity of up to 97 percent. Personalized calibration, tested on four patients over the course of several weeks, can improve the accuracy to 0.92 grams/deciliter, a degree of accuracy on par with point-of-care blood-based hemoglobin tests. Normal values are 13.5-17.5 grams/deciliter for males and 12.0-15.5 grams/deciliter for females.
 
In the app, the use of fingernail beds, which do not contain melanin, means the test can be valid for people with a variety of skin tones. The accuracy is consistent for dark or light skin tones, Mannino said. The app uses image metadata to correct for background brightness and can be adapted to phones from multiple manufacturers.
 
Mannino and Lam say they are working with a variety of doctors at Emory and Children's—geriatric, internal medicine, neonatologists, transfusion medicine, global health—to obtain additional data and better calibrate their system.
 
"This is just a snapshot of the accuracy right now," Lam said. "The algorithm gets smarter with every patient enrolled."
 
The research was supported by the National Science Foundation (Graduate Research Fellowship DGE-1650044 and Southeastern Nanotechnology Infrastructure Corridor 1542174), the 2017 Massachusetts General Hospital Primary Care Technology Prize, and National Institutes of Health (R21 EB025646).
 
The smartphone anemia app is projected to be available commercially for public download as soon as Spring of 2019.
 
A patent application has been filed for the anemia app, and Wilbur Lam and Rob Mannino have a financial interest in the success of this product. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-05 10:20:00 [updated_at] => 2018-12-05 10:28:00 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300574","302606","300280","299201","298545","291340","299129","296051","300189","282914","294234","302074","291642","284484","300282","300327","284483","301664","302195","299755","289715","284485","287547","303301"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304064 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179434 [primary_image_old] => [slider_image_id] => 179434 [banner_image] => 0 [title] => AVITA Medical Begins Clinical Study of RECELL System in Pediatric Burn Treatment [short_title] => [summary] => Randomized controlled study is being conducted in Brisbane, Australia. [slug] => avita-medical-begins-clinical-study-of-recell-system-in-pediatric-burn-treatment [body] => AVITA Medical, a global regenerative medicine company, has begun a randomized, controlled clinical study of the RECELL Autologous Cell Harvesting Device (RECELL System) in the treatment of significant superficial partial- and mid-thickness pediatric burns, including scald injuries. The clinical trial is being conducted by the Queensland University of Technology (QUT) in collaboration with the Pegg Leditschke Children’s Burns Centre at Lady Cilento Children’s Hospital in Brisbane, QLD. Treatment of children in the trial has started. The pediatric clinical trial is being led Dr. Bronwyn Griffin, Child Health Research Centre, QUT, and Professor Roy M. Kimble, Lady Cilento Children’s Hospital - Department of Paediatric Surgery.
 
The protocol for the clinical trial was recently presented at the Australian & New Zealand Burn Association Annual Scientific Meeting in Brisbane, Australia, by Dr. Anjana Bairagi, Honorary Research Fellow (Paediatric Surgery) at the Children’s Burns Centre at Lady Cilento Children’s Hospital. The current standard of care for children with partial-thickness burns is cleaning of the wound followed by a dressing application. Limitations of the standard of care include delay in healing of the burn injury, scarring, and pain. The clinical trial will include approximately 90 patients under 18 years old. Patients will be randomized into one of three groups and will be treated either with the RECELL System and Biobrane dressing, the Biobrane dressing alone, or standard care (silver impregnated silicone lined dressing). The primary endpoint will be days to re-epithelization of the burn injury. Secondary endpoints include pain, patient satisfaction and scarring.
 
The RECELL System uses a small amount of a patient’s own skin to prepare Spray-On Skin Cells at the point of care in as little as 30 minutes, providing a new way to treat thermal burns. A small skin sample is enzymatically and mechanically processed in the RECELL System at the point of care to isolate the skin cells to produce a suspension of Spray-On Skin Cells. The regenerative cell suspension includes keratinocytes, fibroblasts, and melanocytes, which play a critical role in wound healing. The suspension can be sprayed directly on a second degree burn or with an expanded skin graft on a third-degree burn, allowing for broad and even distribution of live cells across the entire wound bed. The RECELL System can be used to prepare enough suspension to treat a wound up to 80 times the size of the donor skin sample, so a skin sample approximately the size of a credit card can be used to treat a wound that covers an adult patient’s entire back. Randomized, controlled trials have demonstrated that treatment of acute burn wounds with the RECELL System requires substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment.
 
AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing a REGENERATIVE EPIDERMAL SUSPENSION (RES), an autologous suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment.
 
AVITA Medical’s first U.S. product, the RECELL System, was approved by the U.S. Food and Drug Administration in September 2018. The RECELL System indicated for use in the treatment of acute thermal burns in patients 18 years and older. The RECELL System produces Spray-On Skin Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns, while significantly reducing the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with autografts depending on the depth of the burn injury. Compelling data from randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use in more than 7,000 patients globally, reinforce that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings.

In international markets outside of Europe, the company's portfolio is marketed under the RECELL System brand to promote skin healing in a wide range of applications including burns, chronic wounds and aesthetics. The RECELL System is TGA-registered in Australia, and CFDA-cleared in China.
 
In Europe, AVITA Medical's portfolio of medical device products received CE-mark approval as three tailored product presentations, with three individual brand names. The RECELL Autologous Cell Harvesting Device is designed for the treatment of burns and plastic reconstructive procedures; REGENERCELL Autologous Cell Harvesting Device has been formulated for chronic wounds including leg and foot ulcers; and RENOVACELL Autologous Cell Harvesting Device is tailored for aesthetic applications including the restoration of pigmentation. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-11 09:00:00 [updated_at] => 2018-12-11 09:07:34 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300774","291499","294194","302016","300250","302305","283697","302922","296562","284246","303313","299802","304100","289788","290009","289761","289767","303988","287668","299650"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304590 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179827 [primary_image_old] => [slider_image_id] => 179827 [banner_image] => 0 [title] => Study: Unloading the Left Ventricle 30 Minutes Before Reperfusion in Heart Attack Patients is Safe [short_title] => [summary] => Abiomed is initiating pivotal randomized controlled trial with the FDA. [slug] => study-unloading-the-left-ventricle-30-minutes-before-reperfusion-in-heart-attack-patients-is-safe [body] => Abiomed has announced the results of the U.S. Food and Drug Administration (FDA) STEMI Door-to-Unloading safety and feasibility randomized controlled trial, which show unloading the left ventricle with Impella CP for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock is safe and feasible, when compared to Impella patients reperfused immediately.
 
The results of the prospective, 50 patient, randomized, multi-center trial were recently presented by Navin Kapur, M.D., executive director of the CardioVascular Center for Research and Innovation at Tufts Medical Center, and simultaneously published in Circulation. Dr. Kapur and William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit, Mich., are co-principle investigators of the study.
 
The study found:
“If a reduction of infarct size from unloading before reperfusion is confirmed in a future trial, this concept would enhance the existing guidelines of immediate reperfusion for STEMI patients,” said Dr. Kapur. “Seventy-five percent of patients experiencing their first heart attack will develop heart failure within five years, so new approaches are needed to reduce infarct size and prevent heart failure. Pre-clinical non-human data sets show unloading the left ventricle prior to reperfusion activates a cardioprotective program that reduces reperfusion injury, and could improve the current standard of care.”
 
Abiomed also announces that, in agreement with the FDA, it will move forward with a pivotal, multi-center, prospective, randomized controlled trial comparing unloading with delayed reperfusion to the current standard of care (immediate reperfusion without Impella). The pivotal trial is planned to begin next year.
 
“This safety and feasibility study gives us hope that we can help STEMI heart attack patients in the future by unloading the heart muscle with delayed revascularization. The planned pivotal randomized controlled trial will further examine whether unloading with Impella CP for 30 minutes prior to reperfusion will potentially slow down or avoid the development of heart failure,” said Dr. O’Neill.
 
“We would like to thank the FDA, our dedicated employees, the patients who consented and all the investigators for their efforts to successfully complete this milestone. We look forward to the pivotal study and expanding the clinical science for the field of heart recovery," said Michael R. Minogue, chairman, president, and CEO of Abiomed.
 
The safety and feasibility study design was approved by the FDA, with an independent steering committee and data and safety monitor overseeing the trial and a blinded clinical events committee independently adjudicating study endpoints. Infarct size was evaluated using a cardiac magnetic resonance imaging technique assessed at a blinded core lab. The trial was sponsored by Abiomed.
 
Impella heart pumps are not FDA approved for use in STEMI patients without cardiogenic shock.
 
STEMI is a type of heart attack caused by a blockage in one of the main heart arteries, preventing the flow of oxygen to the heart. It is estimated that 965,000 people a year have heart attacks,1 of which approximately 200,000 are classified as STEMI.2 The current standard of care is sometimes called Door-to-Balloon "DTB", for the goal of minimizing the time it takes an interventional cardiologist to deploy an angioplasty balloon to open the patient’s blocked artery. The recommended treatment in guidelines for STEMI is revascularization (opening the blocked artery) to restore blood flow and oxygen supply to the heart muscle through primary percutaneous coronary intervention (PCI) within 90 minutes or less from the time of first medical contact. I

The Impella 2.5 and Impella CP devices are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD are FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.
 
Based in Danvers, Mass., Abiomed, Inc. is a provider of medical devices that provide circulatory support. Its products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart.

References
1. "Heart Disease and Stroke Statistics 2016 Update: A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee." (Circulation. 2016; 133(4); 38-360).
2. "Recent Trends in the Incidence, Treatment, and Outcomes of Patients with ST and Non-ST-Segment Acute Myocardial Infarction," (Am. J. Med. 2011; 124(1); 40—47). [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-26 03:00:00 [updated_at] => 2018-12-20 08:02:42 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["304175","299793","299872","302199","298415","302016","300250","302305","302922","296562","304399","284246","303313","299802","304100"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 305183 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2585 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 180297 [primary_image_old] => [slider_image_id] => 180297 [banner_image] => 0 [title] => Baxter Begins U.S. Trial for On-Demand Peritoneal Dialysis Solution System [short_title] => [summary] => The system is designed to improve home dialysis experience and simplify therapy management. [slug] => baxter-begins-us-trial-for-on-demand-peritoneal-dialysis-solution-system [body] => Baxter International Inc., a global innovator in renal care, announced that the first patients have been enrolled in a U.S. clinical trial for the company’s on-demand peritoneal dialysis (PD) solution generation system. The innovative system is designed to improve the patient experience by making PD solutions in small batches in the patient’s home. The Food and Drug Administration (FDA) has indicated that the company may proceed with the prospective, multi-center clinical trial.
 
“We are on a journey to transform how kidney disease is identified, managed and treated, with a focus on improving outcomes for patients,” said Laura Angelini, general manager of Baxter’s Renal Care business. “Our on-demand technology is the cornerstone of our innovation pipeline, as we believe the technology will open up new possibilities for therapy delivery while improving the experience for patients today.”
 
The system brings together Baxter’s pioneering innovations in home dialysis, industry-leading drug delivery technology and expertise in water filtration systems. The on-demand technology uses a small water filtration device, concentrates, and Baxter’s Amia automated peritoneal dialysis system to turn the patient’s tap water into dialysis solution, as it is needed to complete each therapy session.
 
Today, patients receive up to 40 boxes of pre-made dialysis solution every four weeks, weighing in at more than 900 pounds on average. These boxes take up a lot of space in a patient’s home, often filling a closet or spare bedroom. Making solution on demand allows Baxter to improve the PD experience by eliminating heavy, six-liter bags that patients must carry around their homes while setting up therapy. On-demand solutions may also drastically reduce the storage space patients need. Because the concentrate bags are smaller and can be used for several dialysis sessions, patients may also be able to reduce the amount of plastic and cardboard they recycle and dispose of daily.
 
The innovative system is designed to be more flexible to meet individual patient needs while simplifying how clinicians manage therapy for their patients. PD solutions are available in different concentrations of glucose, with higher concentrations removing more fluid and waste than lower concentrations. Making solutions on demand means that a physician could add or change the concentrations being used in therapy in near real-time, through Baxter’s Sharesource remote patient management system. The flexibility to adapt therapy would be a significant improvement from current practice, where a clinician manually creates a new prescription, places an order for pre-made solutions and waits for delivery, or keeps even more boxes of solutions on-hand in patients’ homes.
 
The clinical trial assesses the efficacy and safety of the system, with each participant using the new system for 12 weeks. Following conclusion of the trial and study reporting process, Baxter expects to submit a New Drug Application (NDA) for the concentrates and 510(k) for the device to the FDA.
 
Baxter’s on-demand solution technology is an investigative product and not approved for use. Amia with Sharesource is by Rx Only. 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