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    [title] => First Patient Treated for Severe Emphysema with Olympus' Spiration Valve System
    [short_title] => 
    [summary] => The novel, effective endobronchial valve treatment is now used by a physician at a hospital in Philadelphia.
    [slug] => first-patient-treated-for-severe-emphysema-with-olympus-spiration-valve-system
    [body] => Olympus announced the first endobronchial valve treatment of severe emphysema using the FDA-approved Spiration Valve System (SVS). Gerard Criner, M.D., Professor and Founding Chair of the Department of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine, Temple University, successfully performed the minimally invasive procedure at Temple University Hospital.
 
The Spiration Valve is an umbrella-shaped device that is placed in targeted airways of the lung during a short bronchoscopic procedure. Once in place, the SVS redirects air from diseased parts of the lung to healthier parts, allowing the healthier lung tissue to expand and function more effectively.1 With a potential reduction in lung volume, a patient may be able to breathe more easily and experience improvement in their quality of life.2
 
“Dyspnea, or shortness of breath, is the most significant limitation that affects an emphysematic patient’s quality of life,” said Dr. Criner. “When we help alleviate dyspnea, we improve social function and work productivity, not only for patients, but also for their kids, their spouses, and all of those around them.”
 
FDA approval of the SVS was based on results of the EMPROVE clinical trial demonstrating that patients treated with the SVS benefited from statistically significant and clinically meaningful improvements in lung function and quality of life compared to standard of care medical management. The results showed that the SVS offers a favorable risk benefit profile, with a short procedure time.3 Previous clinical study results4 have shown that shorter procedure times may reduce the risk of adverse events. Serious adverse events observed in the study included COPD exacerbations, pneumothorax, pneumonia, and death.
 
Emphysema is a progressive form of Chronic Obstructive Pulmonary Disease (COPD) that has affected 3.4 million people in the U.S., according to the Centers for Disease Control and Prevention.5 The disease causes a loss of elasticity in lung tissue and enlargement of the alveoli. As a result, emphysematous lobes become hyperinflated, causing shortness of breath. Prominent guidelines6,7 now recommend bronchoscopic lung volume reduction using endobronchial valves as an alternative treatment option for severe emphysema to more invasive options, such as surgery.
 
“We are very pleased that doctors are now able to treat patients with the Spiration Valve System,” said Lynn Ray, Executive Director of Endotherapy and Respiratory Marketing, Olympus America, Inc. “Emphysema is a very debilitating disease that negatively affects quality of life. Although endobronchial valves are not right for every patient with severe emphysema, the treatment can be life-changing for those who are good candidates.”
 
A decade of clinical studies has shown that patient selection is one of the most important predictive factors of a good response to bronchoscopic lung volume reduction with endobronchial valves.8,9,10 Patients are selected for this procedure through a screening process that involves a thorough patient evaluation, including examination for any comorbidities, and quantitative CT analysis.
 
References
1 Spiration Valve System. 2018. Summary of Safety and Effectiveness.
2 Criner GJ, Delage A, Voelker K. Late Breaking Abstract - Endobronchial valves for severe emphysema – 12-month results of the EMPROVE trial. European Respiratory Journal 2018;52: Suppl. 62. doi:10.1183/13993003.congress-2018.OA4928.
3 Criner GJ, Delage A, Voelker KG, for the EMPROVE Trial Investigator Group. The EMPROVE Trial - a Randomized, Controlled Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Spiration Valve System for Single Lobe Treatment of Severe Emphysema. American Thoracic Society International Conference Abstracts. 2018:A7753-A7753. doi:10.1164/ajrccm-conference.2018.197.1_ MeetingAbstracts.A7753.
4 Wood DE, Nader DA, Springmeyer SC, et al. The IBV Valve trial: a multicenter, randomized, double-blind trial of endobronchial therapy for severe emphysema. J Bronchology Interv Pulmonol. 2014;21(4):288-297.
5 Centers for Disease Control. Chronic Obstructive Pulmonary Disease: Basics About COPD. https://www.cdc.gov/nchs/fastats/copd.htm. Accessed March 21, 2019.
6 2019 Global Strategy for the Diagnosis, Management, and Prevention of COPD. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2018. http://goldcopd.org. Accessed January 11, 2019.
7 National Institute for Health Care and Excellence. 2017. Endobronchial valve insertion to reduce lung volume in emphysema; Interventional procedures guidance [IPG600]. https://www.nice.org.uk/guidance/ipg600/resources/endobronchial-valve-insertion-to-reduce-lung-volume-in-emphysema-pdf-1899873854992069. Accessed January 11, 2019.
8 Sciurba FC, Ernst A, Herth FJF, et al. A randomized study of endobronchial valves for advanced emphysema. New England Journal of Medicine 2010;363(13):1233-1244. doi:10.1056/NEJMoa0900928.
9 Schuhmann M, Raffy P, Yi Y, et al. CT predictors of response to endobronchial valve lung reduction treatment: Comparison with Chartis. American Journal of Respiratory and Critical Care Medicine 2015;191(7):767-774. doi:10.1164/rccm.201407-1205OC.
10 Herth FJF, Slebos DJ, Criner GJ, Shah PL. Endoscopic Lung Volume Reduction: An Expert Panel Recommendation - Update 2017. Respiration 2017;94(4):380-388. doi:10.1159/000479379. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-04-01 15:33:00 [updated_at] => 2019-04-01 15:38:11 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305604","304107","300573","299654","303316","302199","311006","310992","310355","309564","309243","309187","308446","308217","308074","308066"] [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/2019-04-01/first-patient-treated-for-severe-emphysema-with-olympus-spiration-valve-system/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 299654 [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":"Olympus","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 175747 [primary_image_old] => [slider_image_id] => 175747 [banner_image] => 0 [title] => Olympus Introduces OER-Mini Endoscope Reprocessor for ENT [short_title] => [summary] => Tabletop endoscope reprocessor features 16-minute reprocessing time; helps reduce the risk of human errors and mishandling. [slug] => olympus-introduces-oer-mini-endoscope-reprocessor-for-ent [body] => Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced the introduction of its OER-Mini tabletop endoscope reprocessor for ENT, an advancement over manual reprocessing for busy ENT facilities. The OER-Mini reflects the trend in healthcare of transitioning more procedures and functions from the hospital to the ambulatory center or clinic, providing cost-savings to the healthcare system overall while maintaining the highest infection control and patient safety standards.
 
The OER-Mini is a tabletop endoscope reprocessor that helps to improve reprocessing efficiency by removing some manual steps of reprocessing endoscopes through high level disinfecting. The OER-Mini has a quick reprocessing time at just 16 minutes and is designed specifically for Olympus endoscopes. The OER-Mini helps reduce the risk of human error and mishandling during the reprocessing process.
 
Multiple societies have highlighted the benefits of automated endoscope reprocessors versus manual high-level disinfection, including AAMI, AORN and the CDC, which states, “Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing: they automate and standardize several important reprocessing steps, reduce the likelihood that an essential reprocessing step will be skipped, and reduce personnel exposure to high-level disinfectants or chemical sterilants.”
 
Key features and benefits of the OER-Mini include:
   
“In ENT, we see many facilities that are still manually reprocessing their flexible endoscopes,” said Dana Currier, business unit vice president, ENT at Olympus America Inc. “Given the diligent attention to detail needed for manual cleaning, as well as the increasing demands for efficiency at today’s ENT clinics, our customers have been asking us for a viable infection control solution for flexible ENT endoscopes. We’re very pleased to provide that solution in a compact package designed that addresses the aims of value-based care.” [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-05 10:42:00 [updated_at] => 2018-10-05 10:45:22 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["282554","280186","277313","289756","289787","290022","299086","289752","282512","290992","281100","288231","278239","289785","284483","280165","288067"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300573 [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":"Olympus Corp.","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176522 [primary_image_old] => [slider_image_id] => 176522 [banner_image] => 0 [title] => Olympus 3D/FlexDex for Minimal Access Surgery Simplifies Suturing, Redefines Robotics [short_title] => [summary] => Pairing of ENDOEYE FLEX 3D and FlexDex Needle Driver to be demonstrated at American College of Surgeons Clinical Conference. [slug] => olympus-3dflexdex-for-minimal-access-surgery-simplifies-suturing-redefines-robotics [body] => Olympus announced the launch of the ENDOEYE FLEX 3D and the FlexDex Needle Driver (3D/FlexDex) laparoscopic surgical solution. Through an exclusive U.S. distribution agreement, Olympus is leveraging its innovative ENDOEYE FLEX 3D laparoscopic imaging technology with the wristed needle-driver of FlexDex to enhance the capabilities of minimal access surgery while providing a cost-effective robotic solution. 3D/FlexDex can be used during many types of procedures, including but not limited to general surgery and gynecological specialties.
 
Olympus' 3D imaging combined with FlexDex technology simplifies suturing in difficult-to-reach areas by precisely translating the surgeon's hand, wrist and arm movements from outside the patient into corresponding movements of an end-effector inside the patient's body. With a chip-on-tip and dual lens design, the ENDOEYE FLEX 3D video laparoscope restores natural 3D vision and depth perception during laparoscopic procedures and mimics what the human eye would see in open surgery. The 3D/FlexDex platform offers an alternative to high-cost robotics in minimal access surgery by providing the visualization and wristed instrumentation for suturing found in robotic technology, but at a fraction of the cost. Importantly, this technology can be used in any OR, at any time, on a laparoscopic platform already familiar to surgeons. With Olympus' extensive market reach and advanced 3D technology, 3D/FlexDex is poised to redefine robotics in minimal access surgery.
 
Features of 3D/FlexDex include:
   
"I am very excited about the 3D/FlexDex platform. My initial findings based on performing over 200 surgeries using the platform indicate significant improvement in suturing technique, with an elimination of all tacking devices and all surgeries completed without complications," said Dr. Kent Bowden, DO, FACOS. "Surgeons such as myself serving a rural population of patients in small community hospitals need the advanced capabilities and cost-effective solutions provided by the 3D/FlexDex platform."
 
"Olympus and FlexDex are redefining minimal access surgery in the OR," said Todd Usen, President, Olympus Medical Systems Group. "We expect this solution to offer surgeons the precision and control they desire without the burden of a complex and costly computer-aided robotic system. This will not only improve patient outcomes and satisfaction but also help healthcare institutions provide true value-based care."
 
"Through our Olympus partnership, FlexDex is going to disrupt the paradigm where surgeons and hospitals had to choose between high cost/high function and low cost/low function," said Dr. James Geiger, CEO at FlexDex. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-22 14:18:00 [updated_at] => 2018-10-22 14:22:45 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["299654","282554","280186","289756","289787","290022","299086","288599","281759","293606","282688","292427","279005","281653","296474","278633","281921","279892","287814"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302199 [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":"Mack Molding","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177889 [primary_image_old] => [slider_image_id] => 177889 [banner_image] => 0 [title] => Mack Molding Promotes Business Development Director to Top Sales Role [short_title] => [summary] => Company combines northern and southern divisions' business development teams. [slug] => mack-molding-promotes-business-development-director-to-top-sales-role [body] => Mack Molding, a custom plastics molder and supplier of contract manufacturing services, is uniting the business development teams of its northern and southern divisions under the leadership of Jonathan Whitney, the company's director of business development. Within this role, Whitney joins Mack's senior staff, reporting directly to President Jeff Somple with dotted-line responsibility to Mack South President Bryan Campbell.

"Jon is a seasoned member of the Mack family and an accomplished engineer," Somple said. "During his tenure with us he has consistently shown a keen ability to target new markets, driving sales growth and increased diversity in our customer base. Unifying our sales teams under Jon not only reflects his contributions to the organization, it allows us to bring increased focus and strategic execution to the prospecting and onboarding of new customers."

Whitney, who has served as the director of business development for the company's Northern Division since 2016, first joined Mack in 2013 as a business development manager for New England. An expert in contract manufacturing, plastics and medical devices, he previously was a senior project manager for the design, development and commercialization of cardiovascular devices at Abiomed. He gained other engineering experience at Olympus, Alkermes and Raytheon, where he earned a green belt six-sigma certification. Whitney has an M.B.A. from Babson College in Wellesley, Mass.; a masters degree in engineering management from Tufts University in Boston; and a bachelors in plastics engineering from UMass Lowell.

Mack Molding is a custom plastics molder and supplier of contract manufacturing services. Mack specializes in plastics design, prototyping, molding, sheet metal fabrication, full-service machining and medical device manufacturing. Founded in 1920, Mack is a privately owned business that operates 11 facilities throughout the world. Don Kendall is CEO and chairman. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-13 02:34:00 [updated_at] => 2018-11-13 02:47:50 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["283359","299793","299872","300573","299654","282554","289756","289787","290022","299086","283374"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303316 [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] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"SImon Trinh, Senior Research Analyst; Jeffrey Wong, Analyst Director;","title":"iData Research"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 178872 [primary_image_old] => 0 [slider_image_id] => 178872 [banner_image] => 0 [title] => 4K Surgical Video Market Shows Massive Growth Coming in China and Japan [short_title] => [summary] => Massive growth in OR equipment is driving the excitement of upgrading to 4K resolution in surgical displays and cameras. [slug] => 4k-surgical-video-market-shows-massive-growth-coming-in-china-and-japan [body] => Due to the emergence of advanced diagnostic and imaging technology for the operating room (OR), operating spaces are becoming increasingly congested and complex with a multitude of OR devices and monitors. As a result, ORs are becoming more ergonomically designed and purposefully built with systems that increase efficiency in order to reduce procedure time and improve surgery success rates.
 
These ORs, known as integrated and hybrid ORs, utilize the most advanced video systems, digital image capture devices, integration hubs/routers/racks, and other capital equipment used in the medical industry. Massive growth in OR equipment is driving the excitement of upgrading to 4K resolution in surgical displays and cameras.

Advanced Imaging and Video Systems
Hybrid ORs incorporate imaging technology like computed tomography (CT), magnetic resonance (MR), and C-arm X-ray systems to assist surgeons in performing quicker, more successful surgeries. By bringing imaging into or adjacent to the surgical space, patients don’t have to be moved during and between surgery, reducing risk and inconvenience. Hybrid ORs require a high investment cost, due to the integration of some of the most advanced imaging and video systems available in the medical device market. Currently, all the hype surrounds 4K devices, with a horizontal screen display resolution of approximately 4,000 pixels. In the healthcare industry, 4096 × 2160 (DCI 4K) is considered the “full 4K” resolution, although many companies still offer UHD displays, which have a resolution just slightly lower than 4K (3840 x 2160 pixels).

High Anticipated Growth, Particularly in China
4K devices are expected to experience moderate to high growth in most countries around the world. In Japan, UHD surgical displays have been available and the market has been growing for the last several years at low double-digit rates. 4K surgical displays are available in Japan, but not as widely used compared to UHD displays. Although a growing percentage of facilities have converted to UHD and 4K, there is still a considerable HD installed base in both Japan and China. The conversion of this installed base will continue to drive growth in the number of units sold in the market.


4K surgical cameras, on the other hand, are newer to the market and the market has been experiencing double-digit growth rates. Surgical camera systems are used primarily in minimally invasive surgeries (MIS). MIS procedures result in faster recovery time, fewer infections, and significant overall savings compared to open surgeries. For these reasons and more, hospitals are willing to invest a significantly higher amount on upgrading HD devices to a much higher quality 4K device. Over the next seven years, the market for 4K surgical cameras in Japan is expected to continue significant growth.

In China, due to their slow regulatory and approval process, 4K cameras did not receive official approval and no devices were sold until 2018. However, in early 2018, the Chinese government officially allowed sales of 4K camera systems, granting permission to several companies including Arthrex, Olympus, and Richard Wolf. However, UHD surgical displays were already sold in China and were quickly gaining popularity among hospitals, with sales volume growing at rates in the mid-teens. Over the next seven years, the market for UHD displays is expected to continue double-digit growth, while the market for 4K cameras is expected to take off and exhibit growth rates in the high teens as well.


Leading Competitors
In Japan, the leading competitors for 4K camera devices are Olympus, Arthrex, and Richard Wolf. Olympus released the VISERA 4K UHD camera system in 2015, making it one of only three major companies that offer a 4K camera system. In late 2014, Arthrex released the SynergyUHD4 4K camera system, which was the world’s first 4K camera on the market. The continued success of the SynergyHD3 camera system and the introduction of the first 4K camera has fostered high brand recognition for Arthrex. In 2017, Richard Wolf released its ENDOCAM Logic 4K surgical camera heads and CCUs into the market. This 4K platform can be used efficiently in all endoscopic specialties and can be incorporated within operating room integration systems like Richard Wolf’s core nova.

For the surgical display markets, Olympus, EIZO, and Barco were the main competitors in both Japan and China. Olympus entered the display market through a partnership with SONY which enabled the company to offer a 4K UHD system. On June 6, 2016, EIZO acquired Panasonic Healthcare Co., Ltd.'s endoscopy monitor business. This acquisition provides EIZO with a complete lineup of endoscopy monitors including 3D and 4K. Barco offers the MDSC line of surgical displays, which come in sizes ranging from 19” to 58”. Its 58” Quad UHD MDSC-8258 display was designed specifically for hybrid ORs and features multi-modality imaging and 3,840 x 2,160-pixel density. 

Market Insights
As adoption rates for 4K devices begin to rise, one of the greatest limiters of growth will be the entrance of new competitors, particularly Asian manufacturers offering lower-priced products. This does not necessarily force established players to reduce prices, but it does lower the average price, particularly in countries like China where these low-priced products are gaining market share. However, top-tiered hospitals understand that 4K camera systems carry a higher cost than their HD counterparts, and are willing to pay a higher price to ensure top-quality product for critical, life-or-death procedures.

References
China Market Report Suite for Video and Integrated Operating Room Equipment 2019 – MedSuite, iData Research
Japan Market Report Suite for Video and Integrated Operating Room Equipment 2019 – MedSuite, iData Research


Simon Trinh is a senior research analyst at iData Research, with many years of experience researching the Asia-Pacific and European markets and was the lead researcher on the study mentioned in this article on operating room equipment.
 
Jeffrey Wong is the analyst director at iData Research. Through many years of analysis, he has been the lead on most of iData’s medical, dental, and pharmaceutical market research and now drives research strategy, product development, and consulting research. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-03 09:30:00 [updated_at] => 2018-12-03 09:53:55 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300573","299654","289756","289787","290022","302199","299086","302208","114892","298884","283033","301046","302106","289765","287215","206410","284626","284027","293606"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304107 [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. Department of Justice","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179478 [primary_image_old] => [slider_image_id] => 179478 [banner_image] => 0 [title] => Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time [short_title] => [summary] => Olympus admitted that it failed to file with the FDA required adverse event reports in 2012 and 2013 relating to three separate infection events. [slug] => olympus-fined-85m-in-endoscope-case-former-executive-faces-jail-time [body] => Olympus Medical Systems Corporation and a former senior executive in Japan pleaded guilty in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes, and continuing to sell the duodenoscopes in the United States despite those failures, the Justice Department announced.
 
Olympus, which is located in Tokyo, Japan, and Hisao Yabe, 62, of Japan, both entered guilty pleas before U.S. District Court Judge Stanley R. Chesler in Newark Federal Court: Olympus to three counts, and Yabe to one count, of distributing misbranded medical devices in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). 
 
Judge Chesler also imposed sentence on the company—fining Olympus $80,000,000 and ordering $5,000,000 in criminal forfeiture, consistent with a plea agreement between Olympus and the Justice Department. Olympus must also abide by an agreement with the Justice Department requiring Olympus to enact extensive compliance reforms.
 
Yabe is scheduled to be sentenced by Judge Chesler on March 27, 2019. Yabe faces a maximum potential penalty of a year in prison and a $100,000 fine, or twice the gain or loss from the offense.
 
Olympus admitted that it failed to file with the Food and Drug Administration (FDA) required adverse event reports in 2012 and 2013 relating to three separate events involving infections in Europe connected to Olympus’s TJF-Q180V duodenoscope (Q180V): the infection of approximately 22 patients with Pseudomonas aeruginosa at the Erasmus Medical Center in the Netherlands in early 2012; the infection of three patients with Escherichia coli at Clinique de Bercy in France in November 2012; and the infection of five patients with Pseudomonas aeruginosa at Kremlin Bicetre in France in July 2012.
 
Yabe admitted his own personal responsibility for the failure to file the necessary information with FDA relating to the Erasmus Medical Center infections. At the time, Yabe was Olympus’s Division Manager for the Quality and Environment Division—Olympus’s top regulatory official, whose responsibilities included adverse event reporting in the United States. 
 
“Medical devices, such as the Olympus duodenoscope that is used in 500,000 procedures per year in the United States, can extend and improve the quality of life for many people,” said Assistant Attorney General Jody Hunt for the Department of Justice’s Civil Division. “But when a device manufacturer becomes aware of risks that could lead to illness, injury, or death, there is a statutory obligation to report that information to the FDA in a timely manner. By failing to do so, Olympus and Mr. Yabe put patients’ health at risk.”
 
“Olympus and Yabe failed to file important FDA reports regarding adverse events,” Attorney for the United States Rachael Honig, District of New Jersey, said. “It is especially troubling that they remained quiet when they received additional information from an independent expert questioning the safety of Olympus’ device. Patient safety must always be a paramount concern for medical device companies, and these defendants simply failed to treat that concern with the gravity it deserves. The resolution is a reminder that this office will act whenever patient safety is put at risk by a quest for profits.”
 
“Medical device adverse event reporting requirements are designed to protect Americans by providing FDA with a tool to detect potential safety issues. When device manufacturers fail to report adverse events, unsuspecting patients are placed at risk,” said FDA Commissioner Scott Gottlieb, M.D. “We take our patient safety mission very seriously and we remain fully committed to aggressively pursuing those who jeopardize public health by subverting FDA’s regulatory requirements.”
 
Olympus’s and Yabe’s Failure to File Required Adverse Event Reports
To enable FDA and others to identify and monitor adverse events, the FDCA requires medical device manufacturers to file adverse event reports—known as Medical Device Reports (MDRs)—when the manufacturer becomes aware of information that reasonably suggests that the manufacturer’s device may have caused or contributed to a death or serious injury. The FDCA also requires manufacturers to file supplemental MDRs if they subsequently obtain information about the event that was not known or available when the initial MDR was filed.
 
Olympus admitted that it failed to make the required initial MDR filing regarding the Kremlin Bicetre infections, and failed to file required supplemental MDRs relating to the Erasmus Medical Center and Clinique de Bercy infections, for which Olympus had filed initial MDRs. Under the FDCA, devices for which required MDRs and supplemental MDRs have not been filed are deemed misbranded, and it is a crime to ship such devices in interstate commerce. Between August 2012 and October 2014, Olympus shipped hundreds of misbranded duodenoscopes in the United States, generating approximately $40 million in revenue and approximately $33 million in total gross profit. Olympus’s payment of $85 million is more than 2½ times Olympus’s total profit from sales of the misbranded duodenoscopes.
 
Yabe admitted that he was aware of Olympus’s obligation to file supplemental MDRs and was involved in Olympus’s failure to file a supplemental MDR regarding the Erasmus Medical Center infections and a report Olympus received prepared by an independent expert of Delft University of Technology in the Netherlands. That expert report—which Olympus obtained in the summer of 2012—noted numerous problems with the Q180V, including that the Q180V’s tip had various cracks, corners, and crevices that could harbor bacteria and could be cleaned only with great difficulty. The report recommended immediate further investigation of all such scopes, updating the cleaning instructions, and improving the quality of the seals.
 
Additional Compliance Measures
As part of its plea agreement with the Justice Department, Olympus has agreed to: retain an independent MDR expert to inspect and review Olympus’s policies and procedures to determine their compliance with the MDR requirements of the FDCA and its implementing regulations; periodic review by the MDR expert of Olympus’s continued compliance with the MDR requirements of the FDCA and its implementing regulations; and conduct a review and audit of the device classification and market pathway for all endoscope device types manufactured by Olympus that are intended for use in the sterile body cavity and that are currently sold in the United States. The MDR expert will report back to FDA and the Justice Department periodically for three years. In addition, the President of Olympus and Olympus’s Board of Directors will periodically conduct a review of Olympus’s MDR compliance measures and classification/marketing pathway review and provide certifications to FDA and the Justice Department relating to those reviews. Olympus also is obligated to inform health care providers in the United States who received Q180Vs between August 2012 and October 2014 of Olympus’s plea, and to provide information to those health care providers regarding Olympus’s failure to file the required MDRs.
 
In March 2016, Olympus Corp. of the Americas and Olympus Latin America, two separate subsidiaries of Olympus Corp., entered into deferred prosecution agreements (DPAs) and civil settlements with the U.S. Attorney’s Office for the District of New Jersey and the Justice Department’s Civil Division to resolve criminal and civil charges and civil claims relating to schemes between 2006-2011 to pay kickbacks to doctors and hospitals in the United States and violate the Foreign Corrupt Practices Act in Latin America. The DPAs are scheduled to expire in March 2019. While the unlawful conduct at issue in the resolution terminated in October 2014—a year and a half before the government entered into the DPAs—conduct relating to violations of the FDCA and failure to file MDRs was specifically not covered by the March 2016 resolution, as the investigation into the FDCA violations was ongoing at that time.
 
The guilty pleas are the culmination of an investigation conducted by special agents from FDA’s Office of Criminal Investigations, under the direction of Special Agent in Charge Jeffrey J. Ebersole of the New York Field Office, along with special agents from the U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Scott J. Lampert, and special agents of the FBI, under the direction of Special Agent in Charge Gregory W. Ehrie.
 
The government is represented in the criminal case by Assistant U.S. Attorneys Jacob T. Elberg and R. David Walk, Jr. of the U.S. Attorney’s Office’s Health Care and Government Fraud Unit, and Senior Litigation Counsel Patrick Jasperse of the Justice Department’s Consumer Protection Branch, with the assistance of Senior Counsel Shannon M. Singleton of the FDA’s Office of Chief Counsel. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-11 14:19:00 [updated_at] => 2018-12-11 14:29:48 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300573","299654","303316","289756","289787","290022","302199","299086","304100","284256","283867","302883","294745","299278","300334","297561","292699","289790"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 299654 [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":"Olympus","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 175747 [primary_image_old] => [slider_image_id] => 175747 [banner_image] => 0 [title] => Olympus Introduces OER-Mini Endoscope Reprocessor for ENT [short_title] => [summary] => Tabletop endoscope reprocessor features 16-minute reprocessing time; helps reduce the risk of human errors and mishandling. [slug] => olympus-introduces-oer-mini-endoscope-reprocessor-for-ent [body] => Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced the introduction of its OER-Mini tabletop endoscope reprocessor for ENT, an advancement over manual reprocessing for busy ENT facilities. The OER-Mini reflects the trend in healthcare of transitioning more procedures and functions from the hospital to the ambulatory center or clinic, providing cost-savings to the healthcare system overall while maintaining the highest infection control and patient safety standards.
 
The OER-Mini is a tabletop endoscope reprocessor that helps to improve reprocessing efficiency by removing some manual steps of reprocessing endoscopes through high level disinfecting. The OER-Mini has a quick reprocessing time at just 16 minutes and is designed specifically for Olympus endoscopes. The OER-Mini helps reduce the risk of human error and mishandling during the reprocessing process.
 
Multiple societies have highlighted the benefits of automated endoscope reprocessors versus manual high-level disinfection, including AAMI, AORN and the CDC, which states, “Automated endoscope reprocessors (AER) offer several advantages over manual reprocessing: they automate and standardize several important reprocessing steps, reduce the likelihood that an essential reprocessing step will be skipped, and reduce personnel exposure to high-level disinfectants or chemical sterilants.”
 
Key features and benefits of the OER-Mini include:
   
“In ENT, we see many facilities that are still manually reprocessing their flexible endoscopes,” said Dana Currier, business unit vice president, ENT at Olympus America Inc. “Given the diligent attention to detail needed for manual cleaning, as well as the increasing demands for efficiency at today’s ENT clinics, our customers have been asking us for a viable infection control solution for flexible ENT endoscopes. We’re very pleased to provide that solution in a compact package designed that addresses the aims of value-based care.” [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-05 10:42:00 [updated_at] => 2018-10-05 10:45:22 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["282554","280186","277313","289756","289787","290022","299086","289752","282512","290992","281100","288231","278239","289785","284483","280165","288067"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 300573 [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":"Olympus Corp.","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 176522 [primary_image_old] => [slider_image_id] => 176522 [banner_image] => 0 [title] => Olympus 3D/FlexDex for Minimal Access Surgery Simplifies Suturing, Redefines Robotics [short_title] => [summary] => Pairing of ENDOEYE FLEX 3D and FlexDex Needle Driver to be demonstrated at American College of Surgeons Clinical Conference. [slug] => olympus-3dflexdex-for-minimal-access-surgery-simplifies-suturing-redefines-robotics [body] => Olympus announced the launch of the ENDOEYE FLEX 3D and the FlexDex Needle Driver (3D/FlexDex) laparoscopic surgical solution. Through an exclusive U.S. distribution agreement, Olympus is leveraging its innovative ENDOEYE FLEX 3D laparoscopic imaging technology with the wristed needle-driver of FlexDex to enhance the capabilities of minimal access surgery while providing a cost-effective robotic solution. 3D/FlexDex can be used during many types of procedures, including but not limited to general surgery and gynecological specialties.
 
Olympus' 3D imaging combined with FlexDex technology simplifies suturing in difficult-to-reach areas by precisely translating the surgeon's hand, wrist and arm movements from outside the patient into corresponding movements of an end-effector inside the patient's body. With a chip-on-tip and dual lens design, the ENDOEYE FLEX 3D video laparoscope restores natural 3D vision and depth perception during laparoscopic procedures and mimics what the human eye would see in open surgery. The 3D/FlexDex platform offers an alternative to high-cost robotics in minimal access surgery by providing the visualization and wristed instrumentation for suturing found in robotic technology, but at a fraction of the cost. Importantly, this technology can be used in any OR, at any time, on a laparoscopic platform already familiar to surgeons. With Olympus' extensive market reach and advanced 3D technology, 3D/FlexDex is poised to redefine robotics in minimal access surgery.
 
Features of 3D/FlexDex include:
   
"I am very excited about the 3D/FlexDex platform. My initial findings based on performing over 200 surgeries using the platform indicate significant improvement in suturing technique, with an elimination of all tacking devices and all surgeries completed without complications," said Dr. Kent Bowden, DO, FACOS. "Surgeons such as myself serving a rural population of patients in small community hospitals need the advanced capabilities and cost-effective solutions provided by the 3D/FlexDex platform."
 
"Olympus and FlexDex are redefining minimal access surgery in the OR," said Todd Usen, President, Olympus Medical Systems Group. "We expect this solution to offer surgeons the precision and control they desire without the burden of a complex and costly computer-aided robotic system. This will not only improve patient outcomes and satisfaction but also help healthcare institutions provide true value-based care."
 
"Through our Olympus partnership, FlexDex is going to disrupt the paradigm where surgeons and hospitals had to choose between high cost/high function and low cost/low function," said Dr. James Geiger, CEO at FlexDex. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-10-22 14:18:00 [updated_at] => 2018-10-22 14:22:45 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["299654","282554","280186","289756","289787","290022","299086","288599","281759","293606","282688","292427","279005","281653","296474","278633","281921","279892","287814"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302199 [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":"Mack Molding","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 177889 [primary_image_old] => [slider_image_id] => 177889 [banner_image] => 0 [title] => Mack Molding Promotes Business Development Director to Top Sales Role [short_title] => [summary] => Company combines northern and southern divisions' business development teams. [slug] => mack-molding-promotes-business-development-director-to-top-sales-role [body] => Mack Molding, a custom plastics molder and supplier of contract manufacturing services, is uniting the business development teams of its northern and southern divisions under the leadership of Jonathan Whitney, the company's director of business development. Within this role, Whitney joins Mack's senior staff, reporting directly to President Jeff Somple with dotted-line responsibility to Mack South President Bryan Campbell.

"Jon is a seasoned member of the Mack family and an accomplished engineer," Somple said. "During his tenure with us he has consistently shown a keen ability to target new markets, driving sales growth and increased diversity in our customer base. Unifying our sales teams under Jon not only reflects his contributions to the organization, it allows us to bring increased focus and strategic execution to the prospecting and onboarding of new customers."

Whitney, who has served as the director of business development for the company's Northern Division since 2016, first joined Mack in 2013 as a business development manager for New England. An expert in contract manufacturing, plastics and medical devices, he previously was a senior project manager for the design, development and commercialization of cardiovascular devices at Abiomed. He gained other engineering experience at Olympus, Alkermes and Raytheon, where he earned a green belt six-sigma certification. Whitney has an M.B.A. from Babson College in Wellesley, Mass.; a masters degree in engineering management from Tufts University in Boston; and a bachelors in plastics engineering from UMass Lowell.

Mack Molding is a custom plastics molder and supplier of contract manufacturing services. Mack specializes in plastics design, prototyping, molding, sheet metal fabrication, full-service machining and medical device manufacturing. Founded in 1920, Mack is a privately owned business that operates 11 facilities throughout the world. Don Kendall is CEO and chairman. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-13 02:34:00 [updated_at] => 2018-11-13 02:47:50 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["283359","299793","299872","300573","299654","282554","289756","289787","290022","299086","283374"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303316 [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] => 2492 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"SImon Trinh, Senior Research Analyst; Jeffrey Wong, Analyst Director;","title":"iData Research"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 178872 [primary_image_old] => 0 [slider_image_id] => 178872 [banner_image] => 0 [title] => 4K Surgical Video Market Shows Massive Growth Coming in China and Japan [short_title] => [summary] => Massive growth in OR equipment is driving the excitement of upgrading to 4K resolution in surgical displays and cameras. [slug] => 4k-surgical-video-market-shows-massive-growth-coming-in-china-and-japan [body] => Due to the emergence of advanced diagnostic and imaging technology for the operating room (OR), operating spaces are becoming increasingly congested and complex with a multitude of OR devices and monitors. As a result, ORs are becoming more ergonomically designed and purposefully built with systems that increase efficiency in order to reduce procedure time and improve surgery success rates.
 
These ORs, known as integrated and hybrid ORs, utilize the most advanced video systems, digital image capture devices, integration hubs/routers/racks, and other capital equipment used in the medical industry. Massive growth in OR equipment is driving the excitement of upgrading to 4K resolution in surgical displays and cameras.

Advanced Imaging and Video Systems
Hybrid ORs incorporate imaging technology like computed tomography (CT), magnetic resonance (MR), and C-arm X-ray systems to assist surgeons in performing quicker, more successful surgeries. By bringing imaging into or adjacent to the surgical space, patients don’t have to be moved during and between surgery, reducing risk and inconvenience. Hybrid ORs require a high investment cost, due to the integration of some of the most advanced imaging and video systems available in the medical device market. Currently, all the hype surrounds 4K devices, with a horizontal screen display resolution of approximately 4,000 pixels. In the healthcare industry, 4096 × 2160 (DCI 4K) is considered the “full 4K” resolution, although many companies still offer UHD displays, which have a resolution just slightly lower than 4K (3840 x 2160 pixels).

High Anticipated Growth, Particularly in China
4K devices are expected to experience moderate to high growth in most countries around the world. In Japan, UHD surgical displays have been available and the market has been growing for the last several years at low double-digit rates. 4K surgical displays are available in Japan, but not as widely used compared to UHD displays. Although a growing percentage of facilities have converted to UHD and 4K, there is still a considerable HD installed base in both Japan and China. The conversion of this installed base will continue to drive growth in the number of units sold in the market.


4K surgical cameras, on the other hand, are newer to the market and the market has been experiencing double-digit growth rates. Surgical camera systems are used primarily in minimally invasive surgeries (MIS). MIS procedures result in faster recovery time, fewer infections, and significant overall savings compared to open surgeries. For these reasons and more, hospitals are willing to invest a significantly higher amount on upgrading HD devices to a much higher quality 4K device. Over the next seven years, the market for 4K surgical cameras in Japan is expected to continue significant growth.

In China, due to their slow regulatory and approval process, 4K cameras did not receive official approval and no devices were sold until 2018. However, in early 2018, the Chinese government officially allowed sales of 4K camera systems, granting permission to several companies including Arthrex, Olympus, and Richard Wolf. However, UHD surgical displays were already sold in China and were quickly gaining popularity among hospitals, with sales volume growing at rates in the mid-teens. Over the next seven years, the market for UHD displays is expected to continue double-digit growth, while the market for 4K cameras is expected to take off and exhibit growth rates in the high teens as well.


Leading Competitors
In Japan, the leading competitors for 4K camera devices are Olympus, Arthrex, and Richard Wolf. Olympus released the VISERA 4K UHD camera system in 2015, making it one of only three major companies that offer a 4K camera system. In late 2014, Arthrex released the SynergyUHD4 4K camera system, which was the world’s first 4K camera on the market. The continued success of the SynergyHD3 camera system and the introduction of the first 4K camera has fostered high brand recognition for Arthrex. In 2017, Richard Wolf released its ENDOCAM Logic 4K surgical camera heads and CCUs into the market. This 4K platform can be used efficiently in all endoscopic specialties and can be incorporated within operating room integration systems like Richard Wolf’s core nova.

For the surgical display markets, Olympus, EIZO, and Barco were the main competitors in both Japan and China. Olympus entered the display market through a partnership with SONY which enabled the company to offer a 4K UHD system. On June 6, 2016, EIZO acquired Panasonic Healthcare Co., Ltd.'s endoscopy monitor business. This acquisition provides EIZO with a complete lineup of endoscopy monitors including 3D and 4K. Barco offers the MDSC line of surgical displays, which come in sizes ranging from 19” to 58”. Its 58” Quad UHD MDSC-8258 display was designed specifically for hybrid ORs and features multi-modality imaging and 3,840 x 2,160-pixel density. 

Market Insights
As adoption rates for 4K devices begin to rise, one of the greatest limiters of growth will be the entrance of new competitors, particularly Asian manufacturers offering lower-priced products. This does not necessarily force established players to reduce prices, but it does lower the average price, particularly in countries like China where these low-priced products are gaining market share. However, top-tiered hospitals understand that 4K camera systems carry a higher cost than their HD counterparts, and are willing to pay a higher price to ensure top-quality product for critical, life-or-death procedures.

References
China Market Report Suite for Video and Integrated Operating Room Equipment 2019 – MedSuite, iData Research
Japan Market Report Suite for Video and Integrated Operating Room Equipment 2019 – MedSuite, iData Research


Simon Trinh is a senior research analyst at iData Research, with many years of experience researching the Asia-Pacific and European markets and was the lead researcher on the study mentioned in this article on operating room equipment.
 
Jeffrey Wong is the analyst director at iData Research. Through many years of analysis, he has been the lead on most of iData’s medical, dental, and pharmaceutical market research and now drives research strategy, product development, and consulting research. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-03 09:30:00 [updated_at] => 2018-12-03 09:53:55 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["300573","299654","289756","289787","290022","302199","299086","302208","114892","298884","283033","301046","302106","289765","287215","206410","284626","284027","293606"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304107 [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. Department of Justice","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179478 [primary_image_old] => [slider_image_id] => 179478 [banner_image] => 0 [title] => Olympus Fined $85M in Endoscope Case; Former Executive Faces Jail Time [short_title] => [summary] => Olympus admitted that it failed to file with the FDA required adverse event reports in 2012 and 2013 relating to three separate infection events. [slug] => olympus-fined-85m-in-endoscope-case-former-executive-faces-jail-time [body] => Olympus Medical Systems Corporation and a former senior executive in Japan pleaded guilty in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes, and continuing to sell the duodenoscopes in the United States despite those failures, the Justice Department announced.
 
Olympus, which is located in Tokyo, Japan, and Hisao Yabe, 62, of Japan, both entered guilty pleas before U.S. District Court Judge Stanley R. Chesler in Newark Federal Court: Olympus to three counts, and Yabe to one count, of distributing misbranded medical devices in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). 
 
Judge Chesler also imposed sentence on the company—fining Olympus $80,000,000 and ordering $5,000,000 in criminal forfeiture, consistent with a plea agreement between Olympus and the Justice Department. Olympus must also abide by an agreement with the Justice Department requiring Olympus to enact extensive compliance reforms.
 
Yabe is scheduled to be sentenced by Judge Chesler on March 27, 2019. Yabe faces a maximum potential penalty of a year in prison and a $100,000 fine, or twice the gain or loss from the offense.
 
Olympus admitted that it failed to file with the Food and Drug Administration (FDA) required adverse event reports in 2012 and 2013 relating to three separate events involving infections in Europe connected to Olympus’s TJF-Q180V duodenoscope (Q180V): the infection of approximately 22 patients with Pseudomonas aeruginosa at the Erasmus Medical Center in the Netherlands in early 2012; the infection of three patients with Escherichia coli at Clinique de Bercy in France in November 2012; and the infection of five patients with Pseudomonas aeruginosa at Kremlin Bicetre in France in July 2012.
 
Yabe admitted his own personal responsibility for the failure to file the necessary information with FDA relating to the Erasmus Medical Center infections. At the time, Yabe was Olympus’s Division Manager for the Quality and Environment Division—Olympus’s top regulatory official, whose responsibilities included adverse event reporting in the United States. 
 
“Medical devices, such as the Olympus duodenoscope that is used in 500,000 procedures per year in the United States, can extend and improve the quality of life for many people,” said Assistant Attorney General Jody Hunt for the Department of Justice’s Civil Division. “But when a device manufacturer becomes aware of risks that could lead to illness, injury, or death, there is a statutory obligation to report that information to the FDA in a timely manner. By failing to do so, Olympus and Mr. Yabe put patients’ health at risk.”
 
“Olympus and Yabe failed to file important FDA reports regarding adverse events,” Attorney for the United States Rachael Honig, District of New Jersey, said. “It is especially troubling that they remained quiet when they received additional information from an independent expert questioning the safety of Olympus’ device. Patient safety must always be a paramount concern for medical device companies, and these defendants simply failed to treat that concern with the gravity it deserves. The resolution is a reminder that this office will act whenever patient safety is put at risk by a quest for profits.”
 
“Medical device adverse event reporting requirements are designed to protect Americans by providing FDA with a tool to detect potential safety issues. When device manufacturers fail to report adverse events, unsuspecting patients are placed at risk,” said FDA Commissioner Scott Gottlieb, M.D. “We take our patient safety mission very seriously and we remain fully committed to aggressively pursuing those who jeopardize public health by subverting FDA’s regulatory requirements.”
 
Olympus’s and Yabe’s Failure to File Required Adverse Event Reports
To enable FDA and others to identify and monitor adverse events, the FDCA requires medical device manufacturers to file adverse event reports—known as Medical Device Reports (MDRs)—when the manufacturer becomes aware of information that reasonably suggests that the manufacturer’s device may have caused or contributed to a death or serious injury. The FDCA also requires manufacturers to file supplemental MDRs if they subsequently obtain information about the event that was not known or available when the initial MDR was filed.
 
Olympus admitted that it failed to make the required initial MDR filing regarding the Kremlin Bicetre infections, and failed to file required supplemental MDRs relating to the Erasmus Medical Center and Clinique de Bercy infections, for which Olympus had filed initial MDRs. Under the FDCA, devices for which required MDRs and supplemental MDRs have not been filed are deemed misbranded, and it is a crime to ship such devices in interstate commerce. Between August 2012 and October 2014, Olympus shipped hundreds of misbranded duodenoscopes in the United States, generating approximately $40 million in revenue and approximately $33 million in total gross profit. Olympus’s payment of $85 million is more than 2½ times Olympus’s total profit from sales of the misbranded duodenoscopes.
 
Yabe admitted that he was aware of Olympus’s obligation to file supplemental MDRs and was involved in Olympus’s failure to file a supplemental MDR regarding the Erasmus Medical Center infections and a report Olympus received prepared by an independent expert of Delft University of Technology in the Netherlands. That expert report—which Olympus obtained in the summer of 2012—noted numerous problems with the Q180V, including that the Q180V’s tip had various cracks, corners, and crevices that could harbor bacteria and could be cleaned only with great difficulty. The report recommended immediate further investigation of all such scopes, updating the cleaning instructions, and improving the quality of the seals.
 
Additional Compliance Measures
As part of its plea agreement with the Justice Department, Olympus has agreed to: retain an independent MDR expert to inspect and review Olympus’s policies and procedures to determine their compliance with the MDR requirements of the FDCA and its implementing regulations; periodic review by the MDR expert of Olympus’s continued compliance with the MDR requirements of the FDCA and its implementing regulations; and conduct a review and audit of the device classification and market pathway for all endoscope device types manufactured by Olympus that are intended for use in the sterile body cavity and that are currently sold in the United States. The MDR expert will report back to FDA and the Justice Department periodically for three years. In addition, the President of Olympus and Olympus’s Board of Directors will periodically conduct a review of Olympus’s MDR compliance measures and classification/marketing pathway review and provide certifications to FDA and the Justice Department relating to those reviews. Olympus also is obligated to inform health care providers in the United States who received Q180Vs between August 2012 and October 2014 of Olympus’s plea, and to provide information to those health care providers regarding Olympus’s failure to file the required MDRs.
 
In March 2016, Olympus Corp. of the Americas and Olympus Latin America, two separate subsidiaries of Olympus Corp., entered into deferred prosecution agreements (DPAs) and civil settlements with the U.S. Attorney’s Office for the District of New Jersey and the Justice Department’s Civil Division to resolve criminal and civil charges and civil claims relating to schemes between 2006-2011 to pay kickbacks to doctors and hospitals in the United States and violate the Foreign Corrupt Practices Act in Latin America. The DPAs are scheduled to expire in March 2019. While the unlawful conduct at issue in the resolution terminated in October 2014—a year and a half before the government entered into the DPAs—conduct relating to violations of the FDCA and failure to file MDRs was specifically not covered by the March 2016 resolution, as the investigation into the FDCA violations was ongoing at that time.
 
The guilty pleas are the culmination of an investigation conducted by special agents from FDA’s Office of Criminal Investigations, under the direction of Special Agent in Charge Jeffrey J. Ebersole of the New York Field Office, along with special agents from the U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Scott J. Lampert, and special agents of the FBI, under the direction of Special Agent in Charge Gregory W. Ehrie.
 
The government is represented in the criminal case by Assistant U.S. Attorneys Jacob T. Elberg and R. David Walk, Jr. of the U.S. Attorney’s Office’s Health Care and Government Fraud Unit, and Senior Litigation Counsel Patrick Jasperse of the Justice Department’s Consumer Protection Branch, with the assistance of Senior Counsel Shannon M. Singleton of the FDA’s Office of Chief Counsel. 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