Boston Scientific touts safety, effectiveness in Rhythmia mapping study

Boston Scientific‘s (NYSE:BSX) Rhythmia mapping system and catheter was found to be safe and effective in procedures to treat arrhythmias, according to a Healio summary of a newly released study from the company.

Researchers in the study examined 572 patients, with 519 patients undergoing procedures with the Rhythmia system and IntellaMap Orion catheter, according to the report. A total of 504 patients had a complete mapping procedure and were followed for one month post-procedure.

Findings from the study were presented at the EHRA 2018 meeting, according to Healio.

The primary endpoint of the trial was acute procedural success as defined by assessing the ability to map an arrhythmia or its substrate, completion of ablation applications and arrhythmia termination where applicable, with validation through appropriate techniques, according to the report.

Investigators reported that 83.3% of patients treated had successful procedures confirmed by arrhythmia-specific validation techniques. They also reported 96% success rate in treating cavotricuspid isthmus-dependent atrial flutter, 83% for non-cavotricuspid isthmus-dependent macro re-entrance atrial tachycardia, 81% for non-macro re-entrance atrial tachycardia, 80% for AF, 64% for ventricular arrhythmias and 94% for other arrhythmias, Healio reported.

Median time or map acquisition during procedures was 29 minutes and 41 seconds, with 73% of patients who had maps collected requiring additional ablation after validation mapping, according to the report.

A total of 61 adverse events in 49 patients were document, with 4% being ablation-related complications and 0.6% related to the mapping catheter, Healio reports.

“In most patients with substrate-based cardiac arrhythmias, electrophysiologic information about the properties of the substrate is key for the development of an appropriate treatment strategy. Currently, substrate-based arrhythmias constitute approximately 75% of all indications in interventional electrophysiology. This technology focuses on the key challenges in interventional and curative treatment of cardiac arrhythmias. However, until the True-HD study was completed, large-scale, multicenter data with more solid information on the mapping ability and properties, safety aspect and outcome, workflow and process effects had not been available,” Dr. Gerhard Hindricks of Germany’s Leipzig University Heart Center said, according to the report.

Yesterday, Boston Scientific released data from the Ranger SFA trial that showed that treatment with its drug-coated balloon succeeded in the femoropopliteal segment after one year and resulted in greater rates of patency, with fewer interventions, compared to standard balloon angioplasty.

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60 Minutes report claims unapproved plastic sources used in Boston Scientific pelvic meshes

Boston Scientific (NYSE:BSX) stocks fell slightly in pre-market trading after being covered in a 60 Minutes episode focused on gynecological pelvic mesh implants which are the source of a massive multi-district litigation, including claims that the company knowingly purchased inauthentic Chinese plastic materials for production.

The Marlborough, Mass.-based company declined an interview with 60 Minutes, which focused on the devices and the 48,000 suits Boston Scientific faces over the allegedly harmful meshes.

Boston Scientific was quoted as having told 60 Minutes that “nearly one million women have been successfully treated […] We have extensively tested the [plastic] resin to confirm its composition, safety and performance.”

The statement won support from the American Urogynecological Society, but other expert sources interviewed by 60 Minutes had contrasting opinions.

Dr. Michael Margolis, a surgeon who has reportedly removed 350 mesh implants and has served as a witness in lawsuits against Boston Scientific, claimed that the meshes cause a chronic inflammatory reaction.

“The slings I’ve removed are substantially altered in their architecture. They are shrunk by at least 50% in width; they are encased in scar tissue. The pores here, these openings here are shrunk substantially,” Dr. Margolis said, according to 60 Minutes.

The report claims that Boston Scientific won FDA clearance for and used “Marlex” branded polypropylene, made by a subsidiary of Chevron Philips, for its meshes, but in 2004 was warned by Chevron Philips that the branded polypropylene should not be used for permanent implantation.

“I can’t, in my wildest imagination, imagine anybody that’s knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body. It’s well known that its oxidatively unstable,” American Chemical Society fellow, plastics engineer and mesh lawsuit witness Duane Priddy said, according to 60 Minutes.

Boston Scientific was cut off from Marlex by Chevron Philips in 2005, though Boston Scientific appealed to the Texas-based company, according to the report. The medtech firm reportedly had to use the Marlex polypropylene, which it estimated it would run out of by 2012, due to it already having received FDA clearance for the specific material.

Boston Scientific appealed to other suppliers of the polypropylene, and was refused by a second supplier in 2010 based on it being used in medical devices, 60 Minutes reported. The company proceeded in an attempt to “use a middleman with ‘no direct link to BSC’,” according to the report, but were unable to find a buyer.

The company found a source in China, Emai, who had “tons of Marlex imported from Chevron Phillips in Texas,” according to the report.

In pursuit of the Marlex, an agent at Boston Scientific wrote to their superiors asking if they needed to specify that the material would be used in implantable medical devices, and was instructed to not disclose what it would be used for, for fear it “could scare them away”, 60 Minutes reported.

During the same month Boston Scientific was seeking new supplies, the FDA released a report on the meshes claiming they had received approximately 4,000 reports of “injury, death and malfunction” and complications including pain, infection, urinary problems, bleeding and organ perforation, according to the report.

Boston Scientific reportedly analyzed the Chinese source of Marlex, comparing it to authentic Marlex from Chevron Philips, and was told that the packaging and labels, including lot numbers, were fraudulent.

The company continued to investigate the plastic, analyzing 11 parameters between the authentic Marlex and the Emai-sourced Marlex, 60 Minutes reports. Only two parameters were the same, with nine reported as different, with four of those parameters reading as “very different.”

Despite these differences, Boston Scientific concluded that the two plastics were the same, according to the report.

Boston Scientific global sourcing division plastics manager Ann Charest concluded that they “believe this is the right material,” and speculated that the lack of documents were due to being imported through improper channels, and that it may have been “redistributed enough times, the original paperwork has been lost/forgotten,” 60 Minutes reports. The company proceeded to purchase a 30 year supply of the Marlex from Emai.

The news program said it hired Priddy to analyze the medtech company’s tests on the plastic after finding the test results in court documents.

“I would predict a significant difference in the antioxidant stability, or I should say the oxidation resistance of those products in the human body,” Priddy told 60 Minutes. He proceeded to confirm that the product was “inferior,” and indicated the product would only last “a few months” in the human body.

In its efforts to import the Emai-sourced plastics, Boston Scientific reportedly hid the original bags the plastics products came in over fears that “if it is caught by customs, we will be in trouble.”

“A plan to hide the bags in plain wrappers was approved in an email sent from the address of Charles Smith, a director in Boston Scientific’s urology and women’s health division,” 60 Minutes reported.

Images and details on the “overbagging” procedure were distributed to executives to approve, the report claims. The company then told the Chinese government that the plastic had been produced in China, and told US customs that the plastic was made in the US, according to the report.

In January 2016, a purported class-action racketeering lawsuit accused Boston Scientific of illegally smuggling counterfeit resin made in China to make pelvic mesh. Shortly after filing, however, a federal judge booted the lawsuit on claims that the FDA has jurisdiction over the case.

In April 2016, a federal probe into the counterfeit resin allegiations reportedly convened a grand jury in West Virginia.

The same firm that filed the the racketeering suit later asked the FDA to ban the medical device maker’s pelvic mesh products made with the allegedly impure resin.

The FDA investigated the change in plastic, but wrote that it “did not find any indication that the change in [plastic] resin led to an increase in adverse events. We have confidence in our […] findings.,” according to 60 Minutes.

In the 60 Minutes report, Priddy goes on to claim that it was “hard for me to imagine somebody looking at that data and generating an opinion that it is acceptable for use in the human body.”

Though Boston Scientific declined an interview with 60 Minutes, it stated that “any allegations continuing to question the integrity or legitimacy of our [plastic] resin are false and irresponsible.”

The news program, in an attempt to confirm whether or not the company was continuing its use of Chinese plastics, purchased 15 mesh kits and analyzed them at a plastics lab, and confirmed that all of the products matched the supposedly inauthentic Chinese plastic.

Shares in Boston Scientific fell 2% in premarket trading early today, but have recovered slightly and are down only approximately 0.1% at $29.95 as of 11:48 a.m. EDT.

In February, Boston Scientific lost another bid as looking to overturn an $18.5 million loss in a product liability suit over alleged injuries caused by its Obtryx pelvic mesh.

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HRS 2018 Roundup: Device-related blood clots with Boston Scientific’s Watchman implant

Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.

There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.

Lead author Dr. Vivek Reddy, of New York’s Mt. Sinai Hospital, told MassDevice.com that the overall incidence of DRT for Watchman in the study was 3.7% using the FDA-approved strategy for anti-coagulation drugs. The surprise, Reddy told us, was the high rate of ischemic stroke in the DRT population.

“It’s surprising, not from a patho-physiological conceptual perspective, but it’s surprising because when we looked at this very early in Protect AF, again a small number of the patients in a relatively small follow-up, we did see that the subsequent stroke rate was a little bit higher, but certainly nothing like this,” he said. “We knew it was important, we knew that you had to do surveillance, we knew that if you see it you need to treat it, but we didn’t expect it to be this high.

“I think what this tells me, is that one has to be aggressive about dealing with device-related thrombus,” Reddy said, noting that it’s less clear how to proceed over the long term than in acute cases.

“It’s pretty clear how you treat it acutely – you give anticoagulation and let it dissolve,” he explained. “What’s less clear, though, is what do you do long-term after that. I think that what I would recommend, not that we have definitive data on this yet, but what I would recommend is aggressive surveillance in those patients who had device-related thrombus. I would recommend that some of them will probably require longer-term anticoagulation. That’s my guess.

“These data I don’t think take away from the argument that Watchman is a reasonable strategy. It doesn’t add or detract from the previous data. What it does do though is, I think it hones in and says when you have this you have to treat those patients aggressively,” Reddy told us.

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60 Minutes to speak to Boston Scientific in coverage of pelvic mesh MDL

CBS’s 60 Minutes will speak to Boston Scientific (NYSE:BSX) this week as the news program covers the massive multi-district litigation over gynecological pelvic mesh implants.

The program referred to the multi-district litigation over the implants as the largest such litigation since asbestos, according to a press release.

In early 2016, the FDA reclassified surgical meshes to treat pelvic organ prolapse in women as a Class III device, moving it up from a Class II classification.

Research has indicated that meshes used transvaginal procedures to treat pelvic organ prolapse can lead to complications including mesh erosion, pain, organ perforation, urinary issues and bleeding and infection.

60 Minutes will be speaking to Marlborough, Mass.-based Boston Scientific about the 48,000 lawsuits they’re facing, according to the release, nearly half of the more than 100,000 women who’ve filed suit against mesh makers. The episode is slated to air at 7:00 p.m. EDT on Sunday.

In February, Boston Scientific lost another bid as looking to overturn an $18.5 million loss in a product liability suit over alleged injuries caused by its Obtryx pelvic mesh.

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Speakers you need to see at DeviceTalks Minnesota

A Google executive whose own heart problems spurred her to seek medtech innovation, a leader at Abbott who wants to drive healthcare value, the head of an upstart company seeking to transform diabetes care — those are but some of the speakers you will encounter at DeviceTalks Minnesota this June.

Read on to find out more about some of the top speakers we’ve lined up for the show. And register soon to attend.

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Attend DeviceTalks Minnesota, June 4–5 in St. Paul>>

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Medtronic taps former JP Morgan analyst Weinstein for strategy SVP | Personnel Moves – May 7, 2018

Medtronic (NYSE:MDT) said today it tapped former J.P. Morgan Chase & Co. analyst Mike Weinstein as its strategy senior VP.

Prior to joining Medtronic, Weinstein served as a managing director for JP Morgan’s equity research healthcare team, holding positions within the unit for more than 20 years, the Fridley, Minn.-based company said.

“We are excited to welcome Mike to Medtronic. He is deeply respected within the industry and brings with him vast knowledge of our markets, technologies, and growth strategies. I look forward to his contributions to the company, including his expert guidance and insights, as well as the new perspective he will bring to our organization,” Medtronic CEO Omar Ishrak said in a press release.

“Mike brings unique and deep insights of the medical device and technology space to Medtronic, developed during a distinguished career in equity research at J.P. Morgan. He will serve as an integral advisor and partner to our senior leaders, and we are thrilled to welcome him to the team,” Medtronic CFO Karen Parkhill said in a prepared statement.

Weinstein joined JP Morgan in 1992, and moved to become the senior medical technology analyst in 1996, Medtronic said. He will assume his position at Medtronic immediately.

“I see in Medtronic the opportunity to continue to create significant shareholder value, and I couldn’t be more excited to join the global leader in medical technology and contribute to its Mission. Having covered Medtronic for more than two decades now, I have full confidence in the outlook and the strategy, and our ability to unlock that value in the months and years ahead,” Weinstein said in a prepared release.

 Endologix lifts COO Onopchenko to the corner office

Endologix (NSDQ:ELGX) said last Wednesday it lifted former COO John Onopchenko to the role of chief executive officer, effective immediately.

Onopchenko served as COO since last October, the Irvine, Calif.-based company said. Prior to joining Endologix, Onopchenko acted as exec VP for Acutus Medical, and has held positions including COO at Volcano.

Onopchenko also spent 10 years at Johnson & Johnson (NYSE:JNJ) leading medical device investments with J&J’s Development Corporation, and held positions with General Electric (NYSE:GE) Medical, Endologix said.

“We are very pleased to welcome John as our chief executive officer. Over the course of the past seven months in the COO role, John has shown the board first hand that he is an exceptional operator with significant manufacturing, clinical, and regulatory experience. His proven skills in scaling and improving productivity in global commercial organizations at Johnson & Johnson and GE Medical and as a medical device venture capitalist give us confidence in his ability to lead Endologix on an exciting path forward. Separately, on behalf of the board of directors, I would like to thank John McDermott for his invaluable contributions to Endologix and for making this transition as smooth as possible,” board chair Dan Lemaitre said in a prepared statement.

“I am honored to be named chief executive officer of Endologix. Since joining the company as COO, I have been deeply involved in the operations of the organization, and I’m excited about the bright future that Endologix has ahead of it. I am looking forward to further advancing the company’s innovative portfolio, enhancing its credibility and reputation with our physicians and customers, and building a culture of accountability, with the ultimate goal of delivering value to our stakeholders around the globe,” Onopchenko said in a press release.

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 Henry Schein names Connett as US medical head

Henry Schein (NSDQ:HSIC) said last week it appointed Brad Connett as its new US Medical Group president, lifting them from their previous position as US Medical commercial group prez.

“Brad has distinguished himself throughout his entire career, and he has been one of the architects of the remarkable growth that Henry Schein Medical has enjoyed in recent years. Brad’s new appointment reflects his excellence as a senior leader and his ability to drive continued growth,” board chair & CEO Stanley Bergman said in a press release.

Connett joined Henry Schein in 1997 after the company acquired Roane-Barker, the company said.

“Throughout the years, Henry Schein Medical has partnered with health care organizations to drive the development and execution of non-acute supply chain strategies. Brad’s strategic vision, deep-rooted industry knowledge, and wide network will advance our ability to deliver innovative solutions that helps our medical professionals operate efficient and profitable practices,” CCO David McKinley said in a prepared statement.

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 Patterson Dental NA prez Misiak steps away

Patterson Dental (NSDQ:PDCO) said last week its North America president is leaving his role on May 11 to pursue a new opportunity.

The company said it will engage in a search for a new dental segment leader, and during the transition the dental biz will report to Mark Walchirk.

“We are grateful to Dave for his many contributions to Patterson during his 22 years with our dental business, and I thank him for his support during my transition. On behalf of Patterson, we wish him the best in his future endeavors,” prez & CEO Mark Walchirk said in a prepared release.

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 Ex-Alere CFO Hinrichs leaves the healthcare field

Former Alere (NYSE:ALR) exec VP and CFO Jim Hinrichs has exited the healthcare industry, taking a position as CFO of plant breeding and production company Cibus.

During his time at Alere, Hinrichs initiated a performance improvement program looking to save over $150 million through integration, standardization and scale-building projects, according to a Cibus release. He also held a CFO position with CareFusion, Cibus said.

“Jim’s leadership will take Cibus to the next level as we execute sales for our robust pipeline of food and agricultural products. His impressive experience in the healthcare and biotech industries offers a well-rounded perspective and will bolster Cibus’ expanding presence in the agriculture industry,” Cibus prez & CEO Peter Beetham said in a press release.

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European Patent Office revokes Edwards Lifesciences patent in TAVR spat with Boston Scientific

Boston Scientific (NYSE:BSX) said today that the European Patent Office revoked a patent owned by Edwards Lifesciences (NYSE:EW) in the latest round of their ongoing spat over transcatheter aortic valve replacements.

In March 2017 a German court issued a mixed decision in the international battle over transcatheter aortic valve replacement patents between the two companies, less than a week after a U.K. patent court handed down a similar decision. Yesterday Boston said it’s confident that the new EPO decision “will have a positive impact on both suits.”

Meanwhile the U.K. High Court is slated to hear the next phase in that case in mid-May, Boston said.

In an email this morning to MassDevice.com, an Edwards spokeswoman said the company plans to appeal.

“We respectfully disagree with the EPO’s decision and will appeal. Edwards pioneered the field of [TAVR] for patients in need, holds the foundational patents for this technology and served as early inventors of the features that we see today on our SAPIEN 3 valve, and we are confident we will ultimately prevail in these matters,” she wrote.

Last month Boston claimed the upper hand in a mixed-bag patent win when the U.K. Court of Appeals dismissed an Edwards appeal, upholding an earlier decision that its Sapien 3 infringes a Boston Scientific patent. The appeals court found that all claims on a single Boston Scientific patent were valid. At the time Edwards added that the U.K. appeals court also found a separate Boston Scientific patent “valid and infringed.”

Boston Scientific said at the time that it plans to appeal a U.S. Patent Office inter partes review finding that certain claims of a US patent related to transcatheter heart valves owned by Boston Scientific asserted against Edwards are invalid. Edwards won a round in March when the U.S. Patent & Trademark Office ruled in its favor.

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Boston Scientific acquires NVision Medical in $275m deal

Boston Scientific (NYSE:BSX) said today it inked a $275 million deal to acquire women’s health-focused NVision Medical, which produces an FDA-cleared device designed to collect cells from fallopian tubes as an early diagnosis of ovarian cancer.

In the deal, Boston Scientific will pay $150 million up front with an additional $125 million in possible milestone payments over four years. The company said it expects the acquisition to be immaterial on an adjusted basis in 2018 and 2019, and accretive after.

“We estimate the near-term market opportunity to be $500 million with the potential to grow to $2 billion as this device is used by more gynecologists to help even more women. We are committed to expanding our women’s health portfolio and driving clinical research that will help deliver innovative options for the prevention and treatment of gynecological cancer,” Boston Scientific MedSurg prez Dave Pierce said in a prepared statement.

Initial studies of NVision’s screening device found that the cells it collected, when tested, correlated with post-surgery definitive diagnoses of ovarian cancer, Marlborough, Mass.-based Boston Scientific said.

Boston Scientific said it plans to conduct additional research with the nVision device to explore how cells it collects from the fallopian tubes can be used to produce diagnoses prior to surgery to aid in decision making for women with increased risk of ovarian cancer.

“We are excited to develop this technology that one day may play an important role in early detection of the disease and the prevention of unnecessary surgeries, while also serving as a foundation for our broader oncology initiatives in both diagnostics and therapeutics,” Boston Scientific global chief medical officer Ian Meredith said in prepared remarks.

“I started nVision with a goal of creating a tool to address an unmet need in women’s health. I am proud of our achievements in advancing efforts to help with the early detection of ovarian cancer and look forward to working with Boston Scientific to move this technology forward,” NVision CEO Surbhi Sarna said in a press release.

Earlier this month, Boston Scientific paid $40 million for the stake in Securus Medical Group it didn’t already own and sweetened the pot with another $10 million in milestones.

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Invuity prez & CEO Sawyer steps down, Flora in as interim | Personnel Moves – March 13, 2018

Invuity (NSDQ:IVTY) said late last week that its president and chief executive officer Philip Sawyer has resigned and will be replaced by board member Scott Flora on an interim basis.

Flora has served as a member of the board since last November, and has held positions as prez, CEO and director of Omniguide. He has also held executive positions at Smith & Nephew (NYSE:SNN), including prez and GM of the orthopedics reconstruction division, GM of the trauma and clinical therapies division and senior VP of US & Europe.

“Phil is a truly visionary leader who over his eight years as president and CEO launched the company, led the initial public offering, introduced incredibly innovative new products and hired great talent. As the company has moved to its next phase, now is the perfect time to bring in a CEO who will execute on the company’s vision and move forward towards profitability while scaling the organization. On behalf of the board we appreciate the contributions that Phil has made to the company and wish him well in his future endeavors. Scott is uniquely qualified to lead Invuity in an interim capacity.  He brings executive leadership experience and domain expertise from his deep experience in the medical device industry.  Additionally, Scott has a familiarity with Invuity from his prior consulting role with the Company, and his recent appointment to the Board, that will enable him to seamlessly step into the interim President and CEO role,” board chair Gregory Lucier said in a prepared statement.

Board chair Lucier said that the company is currently searching for a permanent CEO.

“I am enthusiastic about deepening my relationship with Invuity. I look forward to building on Phil’s work and leading the organization during this interim period. We have terrific employees and customers that are excited about our technology,” Flora said in a press release.

 Endospan taps ex-Endologix exec Mayberry as CEO

Endovascular device developer Endospan said yesterday it tapped former Endologix exec Kevin Mayberry as its new chief executive officer, replacing Alon Shalev, who will stay on as a director.

Prior to his time with Endospan, Mayberry operated in various R&D and executive positions at Endologix after joining the company in 2004. Most recently, Mayberry acted as Asia-Pacific operations regional sales director, based in Singapore.

“This is a very exciting time to be joining Endospan. We have submitted for European approval of our Nexus Stent Graft System, the first off-the-shelf endovascular approach to treating aortic arch disease including aneurysms and dissections. While minimally invasive techniques are standard of care for treating descending aortic disease and heart disease, unfortunately the bridge between the two in the difficult-to-treat aortic arch anatomy is vastly underserved and remains a very invasive, high-mortality open surgery. More than 120,000 patients suffer thoracic aortic arch disease every year in the US and Europe, but only about 25% are diagnosed or treated. This global market opportunity already is greater than $1.3 billion in a segment with no off-the-shelf endovascular options. Consequently, we fully expect NEXUS will be embraced by cardiologists as well as cardiac and vascular surgeons,” Mayberry said in a press release.

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 Physeon names Kullmann as CEO

Vascular medical device developer Physeon said last week it named medtech vet Patrick Kullmann as its new CEO.

Kullmann has previously served in leadership positions at Johnson & Johnson (NYSE:JNJ), Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT), as well as operating in leadership positions with a number of startups.

“We’re very pleased to have Patrick join the Physeon team at such an exciting time in its evolution. Patrick’s background, experience and accomplishments makes him a perfect leader for the organization,” Physeon parent company Novintum Medical Tech CEO Alan Wilson said in a prepared statement.

“I’m thrilled to join the Physeon team as it continues to move toward the anticipated US clinical trial with its disruptive Veinplicity device for venous access. I am confident that my background in leading highly successful teams will translate into establishing and executing a successful FDA trial strategy for future US approval,” Kullmann said in a press release.

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 Raumedic CEO Bayer moves to N.C.

Raumedic said last week its prez and CEO Martin Bayer is moving his office to North America, looking to lead the company from its Mills River, N.C.-based site which is currently under construction.

Last month, Bayer was tapped as board chair for the company, which is looking to establish itself in the US market. In addition to Bayer’s promotion and move, the company said that COO Martin Schenkel was also tapped as board member for the company.

“I look forward to devoting myself to this task, and being on site will provide me with the best conditions,” Bayer said in a press release.

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 TearLab CFO Brazell to resign, Marquez steps in as interim

TearLab Corp. (OTC:TEAR) said late last month that its chief financial officer Wes Brazell is resigning from the company, effective March 30.

The San Diego, Calif.-based company said that the board of directors has appointed finance senior director Michael Marquez as its interim CFO, also effective March 30.

Prior to his time with TearLab, Marquez held positions with Alcon Laboratories and Price Waterhouse Coopers, the company said.

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Appeals court upholds $19m Boston Scientific loss in pelvic mesh case

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Boston Scientific (NYSE:BSX) has lost another bid as it looked to overturn an $18.5 million loss in a product liability suit over alleged injuries caused by its Obtryx pelvic mesh.

A jury in West Virginia federal court in November 2014 found Boston Scientific liable to 4 women following a 10-day trial; the trial judge later ordered the Marlborough, Mass.-based company to pay each of the 4 women damages ranging from $3.25 million to $4.25 million (the 4th plaintiff later settled her case out of court and it was dismissed).

In its appeal, Boston Scientific argued that the court’s decision to consolidate the four cases into a single trial created potential prejudice and confusion amongst the jury.

The appeals court disagreed, saying that “BSC lacks evidence that the district court’s safeguards were inadequate or that consolidation in fact resulted in any prejudice or jury confusion.”

“Instead, it asks us to infer jury confusion based on the similarities of the damages awarded to each plaintiff. Attempting to reverse engineer the jury’s thought processes based on its verdicts is always a dangerous enterprise, because we have no way of knowing what really happened during jury deliberations,” the court wrote, according to official documents. “Here, there is little reason to be suspicious of the verdicts given that BSC had a chance to fully develop its defenses and that the judge properly instructed the jury throughout the trial to keep the cases separate. What is more, the four plaintiffs did not receive identical damage awards, but instead received damages that varied by $1 million across plaintiffs. That the total damages awards were of the same order of magnitude appears to reflect the very similarities between the cases that justified consolidation in the first place.”

Appeals court judges agreed with the district court ruling, saying that it was “well within its discretion in consolidating these four cases for trial,” according to court documents.

Boston Scientific lost another bid looking to overturn the case in October 2016 after arguing that the plaintiffs failed to show that Obtryx is not reasonably safe because it’s within the standard of care for stress urinary incontinence.