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    [title] => First Motor-Controlled Heart Valves Implanted in Europe
    [short_title] => 
    [summary] => The self-expanding aortic valves (CENTERA) were implanted at Mainz University Medical Center.
    [slug] => first-motor-controlled-heart-valves-implanted-in-europe
    [body] => Patients of the Mainz University Medical Center with heart valve disease have recently been able to benefit from a new treatment option for a narrowed aortic valve. Since the beginning of January 2019, cardiologists have implanted a new motor-driven and self-expanding heart valve in three patients in Europe for the first time. The advantage: the valve can be implanted more easily and safely, and leakages after implantation are further minimized.
 
Due to increasing life expectancy, more and more people in Germany are suffering from a symptomatic constriction of the aortic valve. The so-called aortic valve stenosis is the most common heart valve defect of the elderly patient. The standard therapy, especially in younger patients, has been a cardiac-surgical valve replacement. In the last five years, the numbers of catheter-assisted aortic valve replacement therapy (TAVI) have increased tremendously, in particular because of a high proportion of older, partly pre-operated patients. In 2018, there were nearly 20,000 interventions of this kind in Germany. The Department of Cardiology of the Mainz University Medical Center occupies a leading position in the field of minimally invasive heart valve therapy with more than 700 interventions per year. Around 400 TAVI procedures were carried out here last year.
 
Now cardiologists report the first implantations of the latest model of a self-expanding aortic valve (CENTERA) in Mainz.
 
The new heart valve has several advantages for patients:
 
The first three implantations were performed in Mainz by Dr. Ralph Stephan von Bardeleben, Dr. Alexander Tamm, and Professor Andres Beiras-Fernandez on patients aged 73 to 91, two women and one man. Dr. von Bardeleben, head of the Department of Structural Heart Disease and Interventional Heart Valve Therapy, names it "another important step towards a highly accurate and gentle implantation technique that can now largely eliminate potential complications of the procedure in the mostly elderly patients."
 
"The opportunity to implant the first motor-driven heart valves here in Mainz as Europe's first center is an expression of our great expertise and will help us to further expand our national top position in the field of highly innovative minimally invasive heart valves," commented Professor Thomas Münzel, Director of the Department of Cardiology at the Mainz University Medical Center. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-02-21 09:52:00 [updated_at] => 2019-02-21 09:56:27 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["306054","305810","298788","300728","301664","306827","305362","305808","304174","305910","301046"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 [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/2019-02-21/first-motor-controlled-heart-valves-implanted-in-europe/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 298788 [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":"University of Pennsylvania School of Medicine","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 175114 [primary_image_old] => [slider_image_id] => 175114 [banner_image] => 0 [title] => Study: Valve Mismatches Common in TAVR, Ups Risk of Death [short_title] => [summary] => Severe cases of prosthesis-patient mismatch were associated with higher risk of death and hospital readmissions. [slug] => study-valve-mismatches-common-in-tavr-ups-risk-of-death [body] => In the largest multi-institutional study to date, led by researchers from Penn Medicine, the team found that among patients who underwent a transcatheter aortic valve replacement (TAVR), a high number experienced severe and moderate cases of prosthesis-patient mismatch (PPM)—meaning the implanted heart valve is too small for the patient which can lead to inadequate blood flow. The team also found that the risk of death and of heart failure readmissions were 19 percent and 12 percent higher, respectively, after one year as compared to patients without severe PPM.
 
Results of the study were presented today as a late-breaking abstract at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 meeting in San Diego and simultaneously published online in the Journal of the American College of Cardiology.
 
"This is an important contemporary snapshot of what's happening in the real world with commercial TAVR procedures," said the study's lead author Howard C. Herrmann, MD, FACC, MSCAI, the John W. Bryfogle Professor of Cardiovascular Medicine and Surgery at Penn's Perelman School of Medicine and director of Penn Medicine's Interventional Cardiology Program, who presented the results at TCT. "This is the first study that is large enough to demonstrate meaningful data associated with PPM for a relatively new procedure like TAVR. Based on these findings, PPM is an important problem in this population, one that deserves greater awareness among operators. And being aware of it is the first step in trying to prevent it."
 
TAVR was approved by the Food and Drug Administration in 2011 for the treatment of aortic stenosis, a narrowing of the heart's aortic valve, and has revolutionized valve replacement options for patients with this disease who are too sick or too high risk for surgical (open-heart) valve replacement (SAVR). This minimally invasive, catheter-based approach allows physicians to replace the aortic valve without the need to remove the old, damaged one.
 
Of the 62,125 patients who received TAVRs in the United States between 2014 and 2017 and who were evaluated, researchers found 12 percent experienced severe PPM, while 25 percent had moderate PPM. Researchers collected and analyzed patient data from the U.S. STS/ACC Transcatheter Valve Therapy (TVT) Registry, which tracks all commercial procedures performed in the United States. To further study patient outcomes, the authors linked patients in the U.S. STS/ACC TVT registry to Centers for Medicare & Medicaid Services' administrative claims data for 37,470 of their patients. After 30 days, patients with severe PPM had higher rates of heart failure hospitalization, stroke, and death.
 
Historically, PPM has been associated with worse outcomes after SAVR, however, less has been known about the incidence, outcomes, and predictors of PPM in TAVR patients. Past studies have been small, with limited follow up, and some from single centers—combined, they only represent 4,000 patients—and measurement techniques for the valve opening have been inconsistent.
 
PPM is a mismatch of the blood flow dynamics of the prosthetic valve and the amount of blood the heart needs to pump to the rest of the patient's body. For example, having too small of a valve in a person with a large body surface area (height and weight) affects their ability to get enough blood flow when they exercise. In previous studies, severe PPM in both SAVR and TAVR patients have been associated with higher risk of death and hospital readmission, decreased exercise abilities, and a higher rate of valve deterioration over time.
 
The authors identified several predictors of PPM, including patients with a smaller valve prosthesis, those who had a larger body surface area, or patients who are female or younger.
 
"Severe PPM occurs frequently after TAVR procedures, and it results in worse outcomes, even after a short period of one year," Herrmann said. "Now that we're more aware of this, we need to look at strategies and compare devices and techniques in future studies to determine what will help us best limit this risk or avoid it in the future." [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-09-24 10:26:00 [updated_at] => 2018-09-24 10:30:19 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["279724","276392","279187","277167","276448","289348","293290","292170","277517","289951","287545","287752","277124","285583","281550","274882","290580","287957","288790","289770"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300728 [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":"McMaster University","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176640 [primary_image_old] => [slider_image_id] => 176641 [banner_image] => 0 [title] => 'Smart' Surfaces Promise Safer Implants and More Accurate Diagnostic Tests [short_title] => [summary] => Implants could bond to the body without risk of infection or blood clotting. [slug] => smart-surfaces-promise-safer-implants-and-more-accurate-diagnostic-tests [body] => Researchers at McMaster University have solved a vexing problem by engineering surface coatings that can repel everything, such as bacteria, viruses and living cells, but can be modified to permit beneficial exceptions.
 
The discovery holds significant promise for medical and other applications, making it possible for implants such as vascular grafts, replacement heart valves and artificial joints to bond to the body without risk of infection or blood clotting.
 
The new nanotechnology has the potential to greatly reduce false positives and negatives in medical tests by eliminating interference from non-target elements in blood and urine.
 
The research adds significant utility to completely repellent surfaces that have existed since 2011. Those surface coatings are useful for waterproofing phones and windshields, and repelling bacteria from food-preparation areas, for example, but have offered limited utility in medical applications where specific beneficial binding is required
 
“It was a huge achievement to have completely repellent surfaces, but to maximize the benefits of such surfaces, we needed to create a selective door that would allow beneficial elements to bond with those surfaces,” explains Tohid DIdar of McMaster’s Department of Mechanical Engineering and School of Biomedical Engineering, the senior author of a paper that appears in the journal ACS Nano.
 
In the case of a synthetic heart valve, for example, a repellent coating can prevent blood cells from sticking and forming clots, making it much safer.
 
“A coating that repels blood cells could potentially eliminate the need for medicines such as warfarin that are used after implants to cut the risk of clots,” said co-author Sara M. Imani, a McMaster Ph.D. student in Biomedical Engineering.
 
Still, she explains, a completely repellent coating also prevents the body from integrating the new valve into the tissue of the heart itself.
 
By designing the surface to permit adhesion only with heart tissue cells, the researchers are making it possible for the body to integrate the new valve naturally, avoiding the complications of rejection. The same would be true for other implants, such as artificial joints and stents used to open blood vessels.
 
“If you want a device to perform better and not be rejected by the body, this is what you need to do,” said co-author Maryam Badv, also a McMaster Ph.D. student in Biomedical Engineering. “It is a huge problem in medicine.”
 
Outside the body, selectively designed repellent surfaces could make diagnostic tests much more accurate by allowing only the particular target of a test—a virus, bacterium or cancer cell, for example—to stick to the biosensor that is looking for it, a critical advantage given the challenges of testing in complex fluids such as blood and urine.
 
The researchers, who collaborated with Jeffrey Weitz of the Thrombosis & Atherosclerosis Research Institute at Hamilton Health Sciences to understand the challenges related to making successful implants, are now working on the next stages of research to get their work into clinical use. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-24 15:54:00 [updated_at] => 2018-10-24 15:58:01 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["284790","290368","280773","281907","281299","289700","281420","289752","279738","293585","281769","289576","300250","300574","291190","297559"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 301046 [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":"Cleveland Clinic","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176969 [primary_image_old] => [slider_image_id] => 176969 [banner_image] => 0 [title] => The Top 10 Medical Innovations for 2019 [short_title] => [summary] => A panel of top doctors and researchers presents the advancements with the power to transform healthcare in 2019. [slug] => the-top-10-medical-innovations-for-2019 [body] => Alternate therapies for pain. The use of artificial intelligence in healthcare.  Expanded window to treat stroke patients. These are some of the innovations that will enhance healing and change healthcare in the coming year, according to a distinguished panel of doctors and researchers.
 
Cleveland Clinic announced the Top 10 Medical Innovations of 2019 at a multi-media presentation that capped off the 2018 Medical Innovation Summit.  Now in its 16th year, the annual Medical Innovation Summit is organized by Cleveland Clinic Innovations, the development, and commercialization arm of Cleveland Clinic.
 
The list of up-and-coming technologies was selected by a panel of Cleveland Clinic physicians and scientists, led by Michael Roizen, M.D., Chief Wellness Officer at Cleveland Clinic.
 
“Healthcare is ever changing and we anticipate that innovations such as cancer immunotherapy and pharmacogenomics will significantly transform the medical field and improve care for patients at Cleveland Clinic and throughout the world,” said Dr. Roizen.
 
Here, in order of anticipated importance, are the Top 10 Medical Innovations of 2019:
 
1. Alternative Therapy for Pain: Fighting the Opioid Crisis
The opioid crisis has been declared a public health emergency. Today, chronic pain is the leading cause of opioid prescription. Though several clinically validated alternative therapies for chronic pain exist, none have curtailed the crisis. Now, innovation and potential for hope comes by way of pharmacogenomic testing, which uses a patient’s genetic makeup to predict an individual’s metabolism of drugs, including some opiate-based drug. Pharmacogenomic testing can be used to avoid adverse reactions and eliminate unnecessary and ineffective prescriptions, replacing them with more effective medications. Pharmacogenomics can also be used to predict who may have little or no pain relief to some opiate-based analgesics.  Such patients might otherwise finish their prescription quickly and return for a new prescription earlier than expected. Pharmacogenomics can reduce or eliminate the stigma of “drug-seeking” that might be unfairly ascribed to such patients and provide the opportunity to tailor medication therapy.  In 2019, with increased access to genetic testing, pharmacogenomics is poised to make significant inroads into precision medicine and potentially an end to the crisis.



2. The Advent of AI in Healthcare
Once thought as a futuristic threat to humankind, artificial intelligence is now a part of everyday life. In healthcare, AI is changing the game with its applications in decision support, image analysis, and patient triage. Today, artificial intelligence is helping physicians make smarter decisions at the point of care, improving the ease and accuracy of viewing patient scans and reducing physician burnout. For instance, machine learning algorithms have the ability to highlight problem areas on images, aiding in the screening process and quickly making sense of the mountains of data within a physician’s EMR system. With AI’s continued integration into healthcare, caring for patients has become a matter of working smarter, not harder.

 


3. Expanded Window for Acute Stroke Intervention
When it comes to stroke intervention, a timely response is critical. Prolonged lack of blood flow following a stroke can cause irreversible destruction, often resulting in disability. In many cases of stroke, intervention methods can be deployed to save tissue. But until now, intervention of a stroke has only been recommended within a limited window of time. Released this past year, new guidelines suggest an expanded window for treatment. This lengthened timeframe is anticipated to lower the risk of disability and provide opportunity for recovery to an increased number of future stroke patients.

 


4. Advances in Immunotherapy for Cancer Treatment
Cancer immunotherapy, or biologic therapy, is a technique that uses the body’s own immune system to fight cancer. While immunotherapies for cancer have existed for some time, the worldwide work toward a cure for cancer continues to highlight new and novel immunotherapeutic targets. Scientists are creating life-changing new cancer treatments through the concepts of joint therapy and engineered T-cells. With the near-daily discovery of new immunotherapeutic targets and biomarkers, it is the hope that effective therapies will soon exist for all tumor profiles.
 


5. Patient-Specific Products Achieved with 3D Printing
Utilizing 3D printing technology, medical devices can now be matched to the exact specifications of a patient. Designed to be more compatible with an individual’s natural anatomy, devices modeled from patient-specific dimensions have shown greater acceptance by the body, increased comfort, and improved performance outcomes. The versatility provided by 3D printing gives medical practitioners the ability to provide patients the most advanced care, while simultaneously minimizing the risk of complication. Currently, the most significant work in this space includes external prosthetics, cranial/orthopedic implants, and customized airway stents for diseases narrowing the airway. Work in prosthetics and other bodily implants is also gaining speed with some cleared for the commercial market. The technology has also been found helpful in surgical planning. To date, the technology has been used for many complicated heart surgeries and even the Cleveland Clinic’s most recent total face transplant. With its widening healthcare applications, 3D printing is increasing the attention to detail in patient care.
 


6. Virtual and Mixed Reality for Medical Education
Virtual and mixed reality involve the use of computer technology to create simulated and hybrid environments. Popular for their gaming applications, virtual and mixed reality, with their futuristic affect, never fail to dazzle audiences. But VR/MR technology is much more than a game. These reality systems have recently caught the eye of healthcare professionals eager to sharpen their skills. Now popular for medical education, VR/MR programs provide simulation training that serves to enhance traditional medical schooling. With this immersive style of learning, VR/MR training appeals to all types of learners: audio, visual and kinesthetic. Education via simulation is a productive step toward the system’s most adept and confident healthcare providers.
 


7. Visor for Prehospital Stroke Diagnosis
Though less common than ischemic strokes, hemorrhagic strokes—during which blood escapes from a ruptured blood vessel in the brain – are responsible for nearly 40 percent of stroke deaths. Rapid diagnosis is necessary for effective treatment, as uncontrolled bleeding can lead to swelling of, and damage to, the brain. To speed diagnosis, healthcare professionals are using new, advanced technologies such as the hemorrhage scanning visor, which can detect bleeding in the brain. An efficient diagnostic tool, the visor for prehospital hemorrhage scanning serves to speed up diagnosis and the ever-important time to treatment.

 

8. Innovation in Robotic Surgery
Most surgeries performed today are the shortest and least invasive that science will allow. This adaptation in surgical methodology is brought about in part by the integration of robotics. Robots in the operating room provide surgeons with guidance for extreme precision in surgery. Today, surgical platforms are highly advanced and are being used anywhere from spine to endovascular procedures. Shortened recovery time and limited pain after surgery are just a few of the patient benefits seen with minimally invasive robotized surgery. Continued advancement in the field has led to more precise and effective surgeries with improved surgical outcomes.


 
9. Mitral and Tricuspid Valve Percutaneous Replacement and Repair
Cardiac surgery today is less invasive and more routine and effective than its historic counterpart. Performed percutaneously – via a catheter through the skin – many cardiac procedures no longer require an open heart surgery approach. Two such procedures performed this way include replacements and repair of both the mitral and tricuspid valves. Hot on the trail of aortic valve percutaneous intervention, recent percutaneous mitral and tricuspid valve intervention has yielded significant positive outcomes while filling a void in the field of heart surgery. The exploration of this technology in a greater patient population is ongoing, but with promising post-op results, the innovation has significant implications for the future of cardiac care.

 


10. RNA-Based Therapies
Akin to DNA-based gene therapies, RNA-based therapies are the newest innovation in labs nationwide and have shown immense potential. Interfering with genetic data at the ribonucleic acid (RNA) level gives scientists the ability to intercept a patient’s genetic abnormality before it is translated into functioning (or nonfunctioning) proteins. Today, the most popular and successful mechanisms of RNA therapy include antisense nucleotides and RNA interference. These new therapies are being explored in a variety of rare genetic diseases such as Huntington’s disease, as well as in cancer and neurologic diseases, with the hope of treatment by way of alternate genetic data. These new mechanisms of action are opening windows for progress and innovation in therapeutics.
 


Find more information on the annual Top 10 Medical Innovations list including descriptions, videos, and year-by-year comparisons here. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-29 09:12:00 [updated_at] => 2018-10-29 10:08:14 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["280787","299739","281438","285594","300075","284024","284243","283959","299799","300574","299377","298545","294218","281769","281269","281123","279504","283841","280903"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 301664 [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":"U.S. Food and Drug ","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177374 [primary_image_old] => [slider_image_id] => 177374 [banner_image] => 0 [title] => Home-Use Device to Monitor Blood Thinner May Issue Inaccurate Results [short_title] => [summary] => Roche Diagnostics issued a voluntary recall of certain test strip lots used with its CoaguChek test meter devices. [slug] => home-use-device-to-monitor-blood-thinner-may-issue-inaccurate-results [body] => The U.S. Food and Drug Administration is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner, warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Roche Diagnostics issued a voluntary recall of certain test strip lots used with its CoaguChek test meter devices. The recall involves more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from Jan. 12, 2018 to Oct. 29, 2018. The FDA announced this action as a Class I recall, the most serious type of recall, which means the use of these devices may cause serious injuries or death.
 
The FDA is warning patients and health care professionals that they should not rely on these test meter devices to monitor warfarin levels if they’re using test strips affected by the recall. Instead, they should have blood drawn from a vein and have their levels measured by a laboratory test or use an alternative meter device.
 
“These strips are widely used and we are working diligently to warn healthcare providers and the public about the dangers associated with this recall. Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “We are also working with the company on the swift removal of the recalled strips and to ensure the new corrected strips are distributed to patients and health care providers as quickly as possible.”
 
Millions of Americans take the blood thinner warfarin (also known by the brand names Coumadin and Jantoven) to prevent and treat blood clots. The drug may be prescribed for patients with certain types of irregular heartbeats, blood clots in the legs or lungs, or certain medical device implants such as artificial heart valves. Achieving the correct warfarin dosage is crucial, and patients need regular monitoring to test how long it takes their blood to clot. The response is measured by a blood test to check the International Normalized Ratio, or INR. This test can be performed by an accredited laboratory on blood drawn from a vein or with a fingerstick blood draw using an INR test meter at home or in a doctor’s office.
 
The FDA’s warning concerning the CoaguChek XS PT Test Strips is based on medical device reports submitted by Roche Diagnostics to the agency indicating that the test strips may provide results that are higher than the actual INR. As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk for dangerous blood clots. Approximately 90 medical device reports and two serious patient injuries involving strokes were reported to the FDA.
 
Incorrect INR results are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, atrial fibrillation (irregular heartbeat) who are at a high risk of stroke, or those who had a recent blood clot. It is important to note that problems with the CoaguChek XS PT test strips are not likely to be evident to the patient.
 
Roche Diagnostics attributes the cause of the problem to a recent re-calibration of the test strips to a different international standard that occurred earlier this year. They plan to provide new batches of re-calibrated test strips, based on the previous international standard, to their customers by the end of November; the FDA reviewed validation data submitted by the company for these recalibrated strips. The test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST, and CoaguChek Vantus test meter devices.
 
Patients who are using CoaguChek meters should contact their healthcare provider to get information about alternative test methods and to address questions regarding their individual testing schedule. Patients should also contact their patient self-testing service providers to find out when they will be getting their corrected test strips. Health care providers and patients may contact Roche Diagnostics to learn more details about the recall.
 
All healthcare providers, patients, and caregivers are strongly encouraged to voluntarily report INR test meter problems directly to the FDA through MedWatch, the FDA’s voluntary reporting program. Problems should be reported whenever one suspects that there may be an issue with an INR test meter such as a malfunction or incorrect result, or that the meter caused or contributed to a serious injury or death.
 
The FDA is committed to continuing to communicate publicly on this issue and will provide updates related to this recall when available. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-05 10:37:00 [updated_at] => 2018-11-05 10:41:27 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["294634","283597","282557","280927","282664","281188","281299","280635","282688","300250","283697","282390","296562","282544","282670","284246"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304174 [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":"Boston Scientific","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179521 [primary_image_old] => [slider_image_id] => 179521 [banner_image] => 0 [title] => Boston Scientific Wins U.S. Edwards TAVR Patent Dispute [short_title] => [summary] => Edwards owes Boston Scientific infringement damages through the end of 2016. [slug] => boston-scientific-wins-us-edwards-tavr-patent-dispute [body] => Boston Scientific Corporation announced that a jury in the United States (U.S.) District Court for the District of Delaware determined that the Boston Scientific U.S. patent 8,992,608 is valid and that Edwards Lifesciences' Sapien 3 Aortic Valve infringes this patent and that Edwards owes Boston Scientific infringement damages through the end of 2016. Additional damages and interest incurred from 2017-2018 will be determined by the court in post-trial motions.
 
The jury also found that the Boston Scientific LOTUS Aortic Valve System does not infringe Edwards' Spenser patents U.S. 7,510,575, U.S. 9,168,133, or U.S. 9,339,383.
 
"We continue to be encouraged by the sustained record of positive legal rulings, first in European courts and now in the U.S., which upholds our company's intellectual property," said Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary, Boston Scientific.
 
The LOTUS system features an adaptive sealing technology, which creates an external seal to prevent leakage around the valve known as paravalvular leak or PVL, which is a proven predictor of mortality. The company anticipates the LOTUS Edge Valve System will be commercialized in CE mark countries in Q1 2019 and in the U.S. in mid-2019, pending FDA regulatory approval timelines.
 
The LOTUS valve is one of two valve systems in the Boston Scientific structural heart portfolio. Boston Scientific currently offers the ACURATE neo Aortic Valve System in key European markets and is also seeking a CE mark application for the next-generation valve system, the ACURATE neo2, which it intends to commercialize during the first half of 2019.
 
The LOTUS Edge Aortic valve system is an investigational device in the U.S. and is not available for sale. It is pending CE mark. The ACURATE neo and ACURATE neo2 Aortic Valve Systems are not available for use or sale in the US. The LOTUS Valve System is currently not available for use or sale. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-13 08:19:00 [updated_at] => 2018-12-13 08:29:18 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["302686","298784","296561","291566","289730","289770","299795","289756","299803","289791","303994","300637","294049","299790","289744","285583","299797"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 298788 [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":"University of Pennsylvania School of Medicine","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 175114 [primary_image_old] => [slider_image_id] => 175114 [banner_image] => 0 [title] => Study: Valve Mismatches Common in TAVR, Ups Risk of Death [short_title] => [summary] => Severe cases of prosthesis-patient mismatch were associated with higher risk of death and hospital readmissions. [slug] => study-valve-mismatches-common-in-tavr-ups-risk-of-death [body] => In the largest multi-institutional study to date, led by researchers from Penn Medicine, the team found that among patients who underwent a transcatheter aortic valve replacement (TAVR), a high number experienced severe and moderate cases of prosthesis-patient mismatch (PPM)—meaning the implanted heart valve is too small for the patient which can lead to inadequate blood flow. The team also found that the risk of death and of heart failure readmissions were 19 percent and 12 percent higher, respectively, after one year as compared to patients without severe PPM.
 
Results of the study were presented today as a late-breaking abstract at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 meeting in San Diego and simultaneously published online in the Journal of the American College of Cardiology.
 
"This is an important contemporary snapshot of what's happening in the real world with commercial TAVR procedures," said the study's lead author Howard C. Herrmann, MD, FACC, MSCAI, the John W. Bryfogle Professor of Cardiovascular Medicine and Surgery at Penn's Perelman School of Medicine and director of Penn Medicine's Interventional Cardiology Program, who presented the results at TCT. "This is the first study that is large enough to demonstrate meaningful data associated with PPM for a relatively new procedure like TAVR. Based on these findings, PPM is an important problem in this population, one that deserves greater awareness among operators. And being aware of it is the first step in trying to prevent it."
 
TAVR was approved by the Food and Drug Administration in 2011 for the treatment of aortic stenosis, a narrowing of the heart's aortic valve, and has revolutionized valve replacement options for patients with this disease who are too sick or too high risk for surgical (open-heart) valve replacement (SAVR). This minimally invasive, catheter-based approach allows physicians to replace the aortic valve without the need to remove the old, damaged one.
 
Of the 62,125 patients who received TAVRs in the United States between 2014 and 2017 and who were evaluated, researchers found 12 percent experienced severe PPM, while 25 percent had moderate PPM. Researchers collected and analyzed patient data from the U.S. STS/ACC Transcatheter Valve Therapy (TVT) Registry, which tracks all commercial procedures performed in the United States. To further study patient outcomes, the authors linked patients in the U.S. STS/ACC TVT registry to Centers for Medicare & Medicaid Services' administrative claims data for 37,470 of their patients. After 30 days, patients with severe PPM had higher rates of heart failure hospitalization, stroke, and death.
 
Historically, PPM has been associated with worse outcomes after SAVR, however, less has been known about the incidence, outcomes, and predictors of PPM in TAVR patients. Past studies have been small, with limited follow up, and some from single centers—combined, they only represent 4,000 patients—and measurement techniques for the valve opening have been inconsistent.
 
PPM is a mismatch of the blood flow dynamics of the prosthetic valve and the amount of blood the heart needs to pump to the rest of the patient's body. For example, having too small of a valve in a person with a large body surface area (height and weight) affects their ability to get enough blood flow when they exercise. In previous studies, severe PPM in both SAVR and TAVR patients have been associated with higher risk of death and hospital readmission, decreased exercise abilities, and a higher rate of valve deterioration over time.
 
The authors identified several predictors of PPM, including patients with a smaller valve prosthesis, those who had a larger body surface area, or patients who are female or younger.
 
"Severe PPM occurs frequently after TAVR procedures, and it results in worse outcomes, even after a short period of one year," Herrmann said. "Now that we're more aware of this, we need to look at strategies and compare devices and techniques in future studies to determine what will help us best limit this risk or avoid it in the future." [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-09-24 10:26:00 [updated_at] => 2018-09-24 10:30:19 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["279724","276392","279187","277167","276448","289348","293290","292170","277517","289951","287545","287752","277124","285583","281550","274882","290580","287957","288790","289770"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300728 [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":"McMaster University","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176640 [primary_image_old] => [slider_image_id] => 176641 [banner_image] => 0 [title] => 'Smart' Surfaces Promise Safer Implants and More Accurate Diagnostic Tests [short_title] => [summary] => Implants could bond to the body without risk of infection or blood clotting. [slug] => smart-surfaces-promise-safer-implants-and-more-accurate-diagnostic-tests [body] => Researchers at McMaster University have solved a vexing problem by engineering surface coatings that can repel everything, such as bacteria, viruses and living cells, but can be modified to permit beneficial exceptions.
 
The discovery holds significant promise for medical and other applications, making it possible for implants such as vascular grafts, replacement heart valves and artificial joints to bond to the body without risk of infection or blood clotting.
 
The new nanotechnology has the potential to greatly reduce false positives and negatives in medical tests by eliminating interference from non-target elements in blood and urine.
 
The research adds significant utility to completely repellent surfaces that have existed since 2011. Those surface coatings are useful for waterproofing phones and windshields, and repelling bacteria from food-preparation areas, for example, but have offered limited utility in medical applications where specific beneficial binding is required
 
“It was a huge achievement to have completely repellent surfaces, but to maximize the benefits of such surfaces, we needed to create a selective door that would allow beneficial elements to bond with those surfaces,” explains Tohid DIdar of McMaster’s Department of Mechanical Engineering and School of Biomedical Engineering, the senior author of a paper that appears in the journal ACS Nano.
 
In the case of a synthetic heart valve, for example, a repellent coating can prevent blood cells from sticking and forming clots, making it much safer.
 
“A coating that repels blood cells could potentially eliminate the need for medicines such as warfarin that are used after implants to cut the risk of clots,” said co-author Sara M. Imani, a McMaster Ph.D. student in Biomedical Engineering.
 
Still, she explains, a completely repellent coating also prevents the body from integrating the new valve into the tissue of the heart itself.
 
By designing the surface to permit adhesion only with heart tissue cells, the researchers are making it possible for the body to integrate the new valve naturally, avoiding the complications of rejection. The same would be true for other implants, such as artificial joints and stents used to open blood vessels.
 
“If you want a device to perform better and not be rejected by the body, this is what you need to do,” said co-author Maryam Badv, also a McMaster Ph.D. student in Biomedical Engineering. “It is a huge problem in medicine.”
 
Outside the body, selectively designed repellent surfaces could make diagnostic tests much more accurate by allowing only the particular target of a test—a virus, bacterium or cancer cell, for example—to stick to the biosensor that is looking for it, a critical advantage given the challenges of testing in complex fluids such as blood and urine.
 
The researchers, who collaborated with Jeffrey Weitz of the Thrombosis & Atherosclerosis Research Institute at Hamilton Health Sciences to understand the challenges related to making successful implants, are now working on the next stages of research to get their work into clinical use. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-24 15:54:00 [updated_at] => 2018-10-24 15:58:01 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["284790","290368","280773","281907","281299","289700","281420","289752","279738","293585","281769","289576","300250","300574","291190","297559"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 301046 [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":"Cleveland Clinic","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176969 [primary_image_old] => [slider_image_id] => 176969 [banner_image] => 0 [title] => The Top 10 Medical Innovations for 2019 [short_title] => [summary] => A panel of top doctors and researchers presents the advancements with the power to transform healthcare in 2019. [slug] => the-top-10-medical-innovations-for-2019 [body] => Alternate therapies for pain. The use of artificial intelligence in healthcare.  Expanded window to treat stroke patients. These are some of the innovations that will enhance healing and change healthcare in the coming year, according to a distinguished panel of doctors and researchers.
 
Cleveland Clinic announced the Top 10 Medical Innovations of 2019 at a multi-media presentation that capped off the 2018 Medical Innovation Summit.  Now in its 16th year, the annual Medical Innovation Summit is organized by Cleveland Clinic Innovations, the development, and commercialization arm of Cleveland Clinic.
 
The list of up-and-coming technologies was selected by a panel of Cleveland Clinic physicians and scientists, led by Michael Roizen, M.D., Chief Wellness Officer at Cleveland Clinic.
 
“Healthcare is ever changing and we anticipate that innovations such as cancer immunotherapy and pharmacogenomics will significantly transform the medical field and improve care for patients at Cleveland Clinic and throughout the world,” said Dr. Roizen.
 
Here, in order of anticipated importance, are the Top 10 Medical Innovations of 2019:
 
1. Alternative Therapy for Pain: Fighting the Opioid Crisis
The opioid crisis has been declared a public health emergency. Today, chronic pain is the leading cause of opioid prescription. Though several clinically validated alternative therapies for chronic pain exist, none have curtailed the crisis. Now, innovation and potential for hope comes by way of pharmacogenomic testing, which uses a patient’s genetic makeup to predict an individual’s metabolism of drugs, including some opiate-based drug. Pharmacogenomic testing can be used to avoid adverse reactions and eliminate unnecessary and ineffective prescriptions, replacing them with more effective medications. Pharmacogenomics can also be used to predict who may have little or no pain relief to some opiate-based analgesics.  Such patients might otherwise finish their prescription quickly and return for a new prescription earlier than expected. Pharmacogenomics can reduce or eliminate the stigma of “drug-seeking” that might be unfairly ascribed to such patients and provide the opportunity to tailor medication therapy.  In 2019, with increased access to genetic testing, pharmacogenomics is poised to make significant inroads into precision medicine and potentially an end to the crisis.



2. The Advent of AI in Healthcare
Once thought as a futuristic threat to humankind, artificial intelligence is now a part of everyday life. In healthcare, AI is changing the game with its applications in decision support, image analysis, and patient triage. Today, artificial intelligence is helping physicians make smarter decisions at the point of care, improving the ease and accuracy of viewing patient scans and reducing physician burnout. For instance, machine learning algorithms have the ability to highlight problem areas on images, aiding in the screening process and quickly making sense of the mountains of data within a physician’s EMR system. With AI’s continued integration into healthcare, caring for patients has become a matter of working smarter, not harder.

 


3. Expanded Window for Acute Stroke Intervention
When it comes to stroke intervention, a timely response is critical. Prolonged lack of blood flow following a stroke can cause irreversible destruction, often resulting in disability. In many cases of stroke, intervention methods can be deployed to save tissue. But until now, intervention of a stroke has only been recommended within a limited window of time. Released this past year, new guidelines suggest an expanded window for treatment. This lengthened timeframe is anticipated to lower the risk of disability and provide opportunity for recovery to an increased number of future stroke patients.

 


4. Advances in Immunotherapy for Cancer Treatment
Cancer immunotherapy, or biologic therapy, is a technique that uses the body’s own immune system to fight cancer. While immunotherapies for cancer have existed for some time, the worldwide work toward a cure for cancer continues to highlight new and novel immunotherapeutic targets. Scientists are creating life-changing new cancer treatments through the concepts of joint therapy and engineered T-cells. With the near-daily discovery of new immunotherapeutic targets and biomarkers, it is the hope that effective therapies will soon exist for all tumor profiles.
 


5. Patient-Specific Products Achieved with 3D Printing
Utilizing 3D printing technology, medical devices can now be matched to the exact specifications of a patient. Designed to be more compatible with an individual’s natural anatomy, devices modeled from patient-specific dimensions have shown greater acceptance by the body, increased comfort, and improved performance outcomes. The versatility provided by 3D printing gives medical practitioners the ability to provide patients the most advanced care, while simultaneously minimizing the risk of complication. Currently, the most significant work in this space includes external prosthetics, cranial/orthopedic implants, and customized airway stents for diseases narrowing the airway. Work in prosthetics and other bodily implants is also gaining speed with some cleared for the commercial market. The technology has also been found helpful in surgical planning. To date, the technology has been used for many complicated heart surgeries and even the Cleveland Clinic’s most recent total face transplant. With its widening healthcare applications, 3D printing is increasing the attention to detail in patient care.
 


6. Virtual and Mixed Reality for Medical Education
Virtual and mixed reality involve the use of computer technology to create simulated and hybrid environments. Popular for their gaming applications, virtual and mixed reality, with their futuristic affect, never fail to dazzle audiences. But VR/MR technology is much more than a game. These reality systems have recently caught the eye of healthcare professionals eager to sharpen their skills. Now popular for medical education, VR/MR programs provide simulation training that serves to enhance traditional medical schooling. With this immersive style of learning, VR/MR training appeals to all types of learners: audio, visual and kinesthetic. Education via simulation is a productive step toward the system’s most adept and confident healthcare providers.
 


7. Visor for Prehospital Stroke Diagnosis
Though less common than ischemic strokes, hemorrhagic strokes—during which blood escapes from a ruptured blood vessel in the brain – are responsible for nearly 40 percent of stroke deaths. Rapid diagnosis is necessary for effective treatment, as uncontrolled bleeding can lead to swelling of, and damage to, the brain. To speed diagnosis, healthcare professionals are using new, advanced technologies such as the hemorrhage scanning visor, which can detect bleeding in the brain. An efficient diagnostic tool, the visor for prehospital hemorrhage scanning serves to speed up diagnosis and the ever-important time to treatment.

 

8. Innovation in Robotic Surgery
Most surgeries performed today are the shortest and least invasive that science will allow. This adaptation in surgical methodology is brought about in part by the integration of robotics. Robots in the operating room provide surgeons with guidance for extreme precision in surgery. Today, surgical platforms are highly advanced and are being used anywhere from spine to endovascular procedures. Shortened recovery time and limited pain after surgery are just a few of the patient benefits seen with minimally invasive robotized surgery. Continued advancement in the field has led to more precise and effective surgeries with improved surgical outcomes.


 
9. Mitral and Tricuspid Valve Percutaneous Replacement and Repair
Cardiac surgery today is less invasive and more routine and effective than its historic counterpart. Performed percutaneously – via a catheter through the skin – many cardiac procedures no longer require an open heart surgery approach. Two such procedures performed this way include replacements and repair of both the mitral and tricuspid valves. Hot on the trail of aortic valve percutaneous intervention, recent percutaneous mitral and tricuspid valve intervention has yielded significant positive outcomes while filling a void in the field of heart surgery. The exploration of this technology in a greater patient population is ongoing, but with promising post-op results, the innovation has significant implications for the future of cardiac care.

 


10. RNA-Based Therapies
Akin to DNA-based gene therapies, RNA-based therapies are the newest innovation in labs nationwide and have shown immense potential. Interfering with genetic data at the ribonucleic acid (RNA) level gives scientists the ability to intercept a patient’s genetic abnormality before it is translated into functioning (or nonfunctioning) proteins. Today, the most popular and successful mechanisms of RNA therapy include antisense nucleotides and RNA interference. These new therapies are being explored in a variety of rare genetic diseases such as Huntington’s disease, as well as in cancer and neurologic diseases, with the hope of treatment by way of alternate genetic data. These new mechanisms of action are opening windows for progress and innovation in therapeutics.
 


Find more information on the annual Top 10 Medical Innovations list including descriptions, videos, and year-by-year comparisons here. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-29 09:12:00 [updated_at] => 2018-10-29 10:08:14 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["280787","299739","281438","285594","300075","284024","284243","283959","299799","300574","299377","298545","294218","281769","281269","281123","279504","283841","280903"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 301664 [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":"U.S. Food and Drug ","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177374 [primary_image_old] => [slider_image_id] => 177374 [banner_image] => 0 [title] => Home-Use Device to Monitor Blood Thinner May Issue Inaccurate Results [short_title] => [summary] => Roche Diagnostics issued a voluntary recall of certain test strip lots used with its CoaguChek test meter devices. [slug] => home-use-device-to-monitor-blood-thinner-may-issue-inaccurate-results [body] => The U.S. Food and Drug Administration is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner, warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Roche Diagnostics issued a voluntary recall of certain test strip lots used with its CoaguChek test meter devices. The recall involves more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from Jan. 12, 2018 to Oct. 29, 2018. The FDA announced this action as a Class I recall, the most serious type of recall, which means the use of these devices may cause serious injuries or death.
 
The FDA is warning patients and health care professionals that they should not rely on these test meter devices to monitor warfarin levels if they’re using test strips affected by the recall. Instead, they should have blood drawn from a vein and have their levels measured by a laboratory test or use an alternative meter device.
 
“These strips are widely used and we are working diligently to warn healthcare providers and the public about the dangers associated with this recall. Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “We are also working with the company on the swift removal of the recalled strips and to ensure the new corrected strips are distributed to patients and health care providers as quickly as possible.”
 
Millions of Americans take the blood thinner warfarin (also known by the brand names Coumadin and Jantoven) to prevent and treat blood clots. The drug may be prescribed for patients with certain types of irregular heartbeats, blood clots in the legs or lungs, or certain medical device implants such as artificial heart valves. Achieving the correct warfarin dosage is crucial, and patients need regular monitoring to test how long it takes their blood to clot. The response is measured by a blood test to check the International Normalized Ratio, or INR. This test can be performed by an accredited laboratory on blood drawn from a vein or with a fingerstick blood draw using an INR test meter at home or in a doctor’s office.
 
The FDA’s warning concerning the CoaguChek XS PT Test Strips is based on medical device reports submitted by Roche Diagnostics to the agency indicating that the test strips may provide results that are higher than the actual INR. As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk for dangerous blood clots. Approximately 90 medical device reports and two serious patient injuries involving strokes were reported to the FDA.
 
Incorrect INR results are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, atrial fibrillation (irregular heartbeat) who are at a high risk of stroke, or those who had a recent blood clot. It is important to note that problems with the CoaguChek XS PT test strips are not likely to be evident to the patient.
 
Roche Diagnostics attributes the cause of the problem to a recent re-calibration of the test strips to a different international standard that occurred earlier this year. They plan to provide new batches of re-calibrated test strips, based on the previous international standard, to their customers by the end of November; the FDA reviewed validation data submitted by the company for these recalibrated strips. The test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST, and CoaguChek Vantus test meter devices.
 
Patients who are using CoaguChek meters should contact their healthcare provider to get information about alternative test methods and to address questions regarding their individual testing schedule. Patients should also contact their patient self-testing service providers to find out when they will be getting their corrected test strips. Health care providers and patients may contact Roche Diagnostics to learn more details about the recall.
 
All healthcare providers, patients, and caregivers are strongly encouraged to voluntarily report INR test meter problems directly to the FDA through MedWatch, the FDA’s voluntary reporting program. Problems should be reported whenever one suspects that there may be an issue with an INR test meter such as a malfunction or incorrect result, or that the meter caused or contributed to a serious injury or death.
 
The FDA is committed to continuing to communicate publicly on this issue and will provide updates related to this recall when available. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-05 10:37:00 [updated_at] => 2018-11-05 10:41:27 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["294634","283597","282557","280927","282664","281188","281299","280635","282688","300250","283697","282390","296562","282544","282670","284246"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304174 [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":"Boston Scientific","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179521 [primary_image_old] => [slider_image_id] => 179521 [banner_image] => 0 [title] => Boston Scientific Wins U.S. Edwards TAVR Patent Dispute [short_title] => [summary] => Edwards owes Boston Scientific infringement damages through the end of 2016. [slug] => boston-scientific-wins-us-edwards-tavr-patent-dispute [body] => Boston Scientific Corporation announced that a jury in the United States (U.S.) District Court for the District of Delaware determined that the Boston Scientific U.S. patent 8,992,608 is valid and that Edwards Lifesciences' Sapien 3 Aortic Valve infringes this patent and that Edwards owes Boston Scientific infringement damages through the end of 2016. Additional damages and interest incurred from 2017-2018 will be determined by the court in post-trial motions.
 
The jury also found that the Boston Scientific LOTUS Aortic Valve System does not infringe Edwards' Spenser patents U.S. 7,510,575, U.S. 9,168,133, or U.S. 9,339,383.
 
"We continue to be encouraged by the sustained record of positive legal rulings, first in European courts and now in the U.S., which upholds our company's intellectual property," said Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary, Boston Scientific.
 
The LOTUS system features an adaptive sealing technology, which creates an external seal to prevent leakage around the valve known as paravalvular leak or PVL, which is a proven predictor of mortality. The company anticipates the LOTUS Edge Valve System will be commercialized in CE mark countries in Q1 2019 and in the U.S. in mid-2019, pending FDA regulatory approval timelines.
 
The LOTUS valve is one of two valve systems in the Boston Scientific structural heart portfolio. Boston Scientific currently offers the ACURATE neo Aortic Valve System in key European markets and is also seeking a CE mark application for the next-generation valve system, the ACURATE neo2, which it intends to commercialize during the first half of 2019.
 
The LOTUS Edge Aortic valve system is an investigational device in the U.S. and is not available for sale. It is pending CE mark. The ACURATE neo and ACURATE neo2 Aortic Valve Systems are not available for use or sale in the US. The LOTUS Valve System is currently not available for use or sale. 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