Report: Boston Scientific to expand Clonmel, Ireland-based facilities

Boston Scientific (NYSE:BSX) is planning on expanding its Clonmel, Ireland-based facilities at the end of the year, according to a new report from The Nationalist.

The expansion is dependent upon final planning approval which is slated for September, according to the report.

The Marlborough, Mass.-based company plans to add an approximately 34,000 square-foot administration building to its facilities in the area, as well as an additional 155 parking spaces.

Boston Scientific has already won conditional approval from the Tipperary County Council for the expansion, according to The Nationalist.

“We are very positive about this substantial investment in the site’s future,” the company said, according to the report.

Earlier this month, Boston Scientific said that it plans to submit the final technical module for the FDA premarket approval application for its Lotus Edge aortic heart valve system by the end of next week.

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Boston Scientific to submit last FDA PMA module for Lotus Edge aortic valve this month

Boston Scientific (NYSE:BSX) said today it plans to submit the final technical module for the FDA premarket approval application for its Lotus Edge aortic heart valve system by the end of next week.

The good news follows a long string of hurdles the Marlborough, Mass.-based company has faced with the Lotus over the past few years.

Last November, Boston Scientific announced news of a delay that resulted in a $3 billion drop in its market capitalization. Earlier that year in February, the company recalled the Lotus TAVR system over issues with its locking mechanism and said it didn’t expect to be able to get the device back on the market in Europe or to file for changes with the FDA by the beginning of 2018.

Boston paused Lotus implantations in October 2016 to investigate a locking mechanism issue but even though that problem was solved by January 2017, the next month the company voluntarily pulled all Lotus devices from global commercial and clinical sites “due to reports of premature release of a pin connecting the Lotus valve to the delivery system.”

This February, CEO Mike Mahoney confirmed that the Lotus will remain off the market for the rest of the year.

Today the company briefly announced progress towards new FDA approval of the valve in an SEC filing.

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Boston Scientific inks $160m deal for peripheral stent maker Veniti

Boston Scientific (NYSE:BSX) said today it inked a deal worth up to $160 million to acquire stent developer Veniti.

Marlborough, Mass.-based Boston Scientific said it currently owns 25% of the company and will pay $108 million in up-front cash for the remaining stake in Veniti, with an additional $52 million on the line in milestone payments dependent upon FDA approval of its Vici stent system.

The Vici is a nitinol stent system developed specifically for use in the venous anatomy, and is designed to withstand compression and maintain patency and flexibility through out a patient’s lifespan, Boston Scientific said.

Veiniti won CE Mark approval for the Vici stent in 2013 and submitted an FDA premarket approval application in June based on results from a pivotal study of the device. Currently, there are no stents specifically indicated for use in the peripheral venous system in the US, Boston Scientific said.

“This stent system was designed with the distinctive demands of the venous system in mind, and built to provide physicians with a high-quality lumen across a variety of venous anatomies and disease states. We are excited to see this stent technology become even more accessible to physicians and the patients they treat under the leadership of Boston Scientific,” Veniti prez & CEO Jeff Elkins said in a prepared statement.

Boston Scientific said it expects the acquisition to be immaterial to its EPS this year and next, and accretive after.

“With the unique benefits of this differentiated technology and the strong experience of Boston Scientific in the overall venous market, we believe the Vici stent will become an important choice for physicians who choose stents to treat patients suffering from venous disease. Along with our leading AngioJet thrombectomy platform and venous product pipeline, we look forward to meeting the needs of physicians treating both chronic and acute venous disease,” Boston Scientific peripheral interventions prez Jeff Mirviss said in a press release.

Earlier this week, a WARN act report emerged showing 85 upcoming layoffs for Boston Scientific at its Burlington, Mass.-based facilities.

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Boston Scientific inks $202m deal to buy Cryterion Medical

Boston Scientific (NYSE:BSX) said today that it plans to pay $202 million upfront to acquire Cryterion Medical and its single-shot cryoablation device designed to treat atrial fibrillation.

Adding a cryoballoon platform to its portfolio positions the company as the first to have both cryothermal and radiofrequency balloon-based ablation therapies at its disposal, the medtech giant touted.

Boston Scientific has invested in California-based Cryterion Medical since its beginnings in 2016 and the $202-million pricetag represents the remaining 65% stake.

Single-shot ablation therapies are the fastest growing sub-segment within the $5 billion electrophysiology market, Boston Scientific reported.

Cryterion Medical’s platform leverages cryothermal energy to disrupt the irregular electrical signals that can trigger atrial fibrillation. The company’s device is undergoing clinical investigation in Europe and Cryterion Medical plans to submit for CE Mark clearance in early 2019. The company is also slated to pursue regulatory approval in the U.S., aiming to start enrolling patients in an IDE trial next year.

“Initial clinical study results demonstrate that our system has a promising safety profile as well as acute efficacy,” Keegan Harper, Cryterion Medical’s president & CEO, said in prepared remarks. “We look forward to bringing this advanced cryoablation system to market with the support of Boston Scientific.”

“The acquisition of Cryterion Medical enhances our AF ablation procedure offerings, allowing physicians to select a therapeutic option based on clinical preference and specific patient needs,” Dr. Kenneth Stein, SVP & CMO of Boston Scientific’s rhythm management & global health policy unit, added. “We are committed to providing physicians with a comprehensive suite of therapies that lead the way for clinical advancements and address the needs of the increasing population of patients with AF.”

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EuroPCR Roundup: Biotronik touts two-year study comparing drug-eluting stents

Biotronik yesterday presented two-year data from a trial comparing Boston Scientific‘s (NYSE:BSX) Synergy biodegradable polymer everolimus-eluting stent, Biotronik’s Orsiro sirolimus-eluting stent and Medtronic‘s (NYSE:MDT) Resolute Integrity zotarolimus-eluting stent.

Results from the 3,514-patient trial showed no significant difference between the various stents regarding the rate of target vessel failure after two years. But analyses of one-year data found differences between the rates of target lesion revascularization and target lesion failure for patients treated with Orsiro compared to Resolute Integrity, according to Biotronik.

Get the full story at our sister site, Drug Delivery Business News.

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EuroPCR 2018: Study compares drug-coated balloons in patients with arterial in-stent restenosis

At this year’s annual EuroPCR meeting, Boston Scientific (NYSE:BSXtouted results from the first trial to compare two drug-coated balloons with different drug formulations – Boston Scientific’s Agent paclitaxel-coated PTCA device and B. Braun’s SeQuent Please balloon.

The 125-patient study evaluated the balloons in patients with in-stent restenosis of a lesion previously treated with a drug-eluting stent or drug-coated balloon.

Get the full story at our sister site, Drug Delivery Business News.

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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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