Channel Medsystems wins PMA for Cerene cryoablation device

Channel MedsystemsChannel Medsystems last week won pre-market approval from the FDA for its Cerene endometrial cryoablation device, starting the clock on a mandatory three-year post-approval study.

Cerene, which is designed to treat heavy but benign bleeding in premenopausal women for whom child bearing is complete, won CE Mark approval in the European Union in June 2017. The PMA granted March 28 is based on 12-month data from the 242-patient Clarity pivotal trial, which must now be extended for another 36 months, according to the FDA.

Emeryville, Calif.-based Channel Medsystems must follow at least 85% of Clarity patients out to three years, documented by two years worth of bi-annual reports detailing a variety of outcomes, the federal safety watchdog said.

“We are extremely pleased by the results of the Clarity study and the positive feedback we have received about the Cerene device, both from study investigators and numerous gynecologists surveyed,” president & CEO Ric Cote said in prepared remarks. “The Cerene device provides gynecologists with the first realistic option for treatment in their office, a setting that is more comfortable for women and significantly less expensive for the healthcare system. The shift away from the operating room that the Cerene device enables could potentially reduce the cost to treat heavy menstrual bleeding by hundreds of millions of dollars annually.”

“Channel Medsystems has developed a treatment that is easy to use, is reproducible in any setting of care and is very well tolerated without anesthesia. The development of new technology like the Cerene device could allow gynecologists to provide a safe, effective, affordable and convenient treatment to the millions of women who seek care for heavy menstrual bleeding annually in the United States,” added study investigator Dr. Ted Anderson of Nashville’s Vanderbilt University Medical Center.

Channel Medsystems has raised at least $47.6 million in a series of funding rounds that included Boston Scientific (NYSE:BSX), which acquired a 20% stake for $20.6 million spread over two of the rounds. In November 2017 the companies agreed to a deal that would have seen Boston acquire the remaining 80% for $275 million if it won FDA approval by Sept. 30 of this year.

The agreement foundered in the wake of an alleged embezzlement scheme in which federal prosecutors indicted then-quality assurance VP Dinesh Shankar on six counts of mail fraud. Channel sued to enforce the buyout, claiming that Shankar’s theft didn’t affect Channel’s pivotal trial or impede its the PMA bid it filed last August. The case is still under way in a Delaware state court.

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Sterilization plant closures: Here’s why you need to care

(Image by Jose Fontano on Unsplash)

The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant.

Medium-sized and smaller firms, including Teleflex Medical (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. With a Viant sterilization plant in Grand Rapids, Mich. slated to close later this year, the FDA is warning of spot shortages, and smaller medtech companies may be the hardest hit.

Get the full story on our sister site, Medical Design & Outsourcing.

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Boston Scientific prevails in employment case

Boston ScientificBoston Scientific (NYSE:BSX) has won summary judgment in an employment discrimination lawsuit brought by a former regional manager.

Boston Scientific fired the former manager, Michael Simons, in 2015 for impaired job performance due to alcohol consumption, being intoxicated at work events and getting arrested for drunken driving during work hours and failing to disclose the arrest, according to the facts of the case.

After the company issued two written warnings to Simons about his behavior, Simons emailed his supervisor citing complaints by Simons’ staff about the supervisor’s behavior. A company investigation found no wrong-doing.

Simons requested and was granted a 30-day leave to “address his alcoholism.” After his return to work, the company hired a private security team who turned up the DUI arrest. Boston Scientific subsequently fired Simons.

Simons sued the company and two superiors in New Jersey state court following his termination, alleging violations of state anti-discrimination law, the Family Medical Leave Act and a New Jersey employment protection law. Among his claims, Simons referred to the email to his supervisor as “whistleblowing,” although it included his promise to keep it confidential.

The state court ruled that Simons did not prove that Boston Scientific had discriminated against him for taking a leave of absence or that it had fired him for “purported whistleblowing.” A three-judge panel of the U.S. District Court for the Third Circuit agreed and dismissed the case.

Simons’ attorney did not immediately return a call for comment.

 

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Boston Scientific touts Luminize catheter study

Boston ScientificBoston Scientific (NYSE:BSX) this week touted results from a study of a single-shot ablation catheter for atrial fibrillation at a European cardiac rhythm conference.

The Marlborough, Mass.-based medical device giant said the 100-patient AF-ficient I study of intermittent AF proceeded in two stages. Phase one, testing the original Luminize design, showed a pulmonary vein isolation rate of 88.9%; phase two, testing enhanced steering and electrodes, showed a PV isolation rate of 99.4%. The median balloon dwell time dropped from 92 minutes in the first phase to 29 minutes in the second, bringing total procedure time down to a median 71 minutes. There were no device-related serious adverse events in either phase at 30 days, Boston Scientific said.

The results were presented March 17 at the annual meeting of the European Heart Rhythm Assn. in Lisbon.

“The study assessed the safety and effectiveness of isolating PVs through the combined benefits of RF and balloon-based ablation, both of which are found in the Luminize RF balloon catheter,” principal investigator Dr. Amin Al-Ahmad, of Austin’s Texas Cardiac Arrhythmia center, said in prepared remarks. “The data underscore the potential for this catheter to improve procedural efficacy and patient outcomes.”

“We are pleased with the data presented today as it highlights the potential benefits of the LUMINIZE RF Balloon Catheter,” added rhythm management and global health policy CMO Dr. Kenneth Stein. “By providing real-time visualization both before and during ablation and individualized control of electrode energy levels, this technology may allow physicians to swiftly and accurately isolate veins and decrease procedure times.”

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Report: Boston Scientific looks to lure Irish expats from Australia to fill its roster

Boston Scientific

In an effort to fill open positions at its Galway, Ireland-based facilities, Boston Scientific (NYSE:BSX) is offering to cover relocation costs for expatriated residents that left for positions in Australia, according to a Connacht Tribune report.

The residents left Galway for Australia during the recent recession, according to the report, leaving a shortage of skilled workers in Ireland.

Due to the shortage, the Marlborough, Mass.-based company has begun head hunting in Australia, looking for senior quality and manufacturing engineers and to fill R&D roles, according to the Connacht Tribune.

Boston Scientific is looking to fill approximately 50 positions in the region, and already employs nearly 3,000 individuals in the regions according to the report.

The company is primarily targeting ex-pats who left due to the recession, but is also looking for Europeans in Australia who are looking to return to the area, according to the Connacht Tribune.

Earlier this week, Boston Scientific said that it won CE Mark approval in the European Union for the next iteration of its Watchman anti-stroke heart implant.

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Boston Scientific wins CE Mark for Watchman FLX anti-stroke implant

Boston Scientific's Watchman FLXBoston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for the next iteration of its Watchman anti-stroke heart implant.

The Marlborough, Mass.-based medical device maker said the Watchman FLX is designed to be easier to implant during procedures to occlude the left atrial appendage and is re-capturable and re-positionable intraprocedurally.

Watchman FLX is under limited release in Europe, with more sites slated to come on line during the second half of the year, Boston Scientific said. A European post-market registry study is also planned, the company said.

“The Watchman device has been implanted in more than 75,000 patients worldwide and we are pleased that this next-generation technology has been granted European regulatory approval so that we can offer it to patients and clinicians throughout Europe,” interventional cardiology president Kevin Ballinger said in prepared remarks. “The robust clinical evidence and successful commercial outcomes of the Watchman device to-date reinforce the value of this procedure for all appropriate patients.”

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Study finds fault with ICD leads that Abbott inherited from St. Jude Medical

AbbottA review of FDA adverse event reports has revealed that some Abbott (NYSE:ABT) implantable cardioverter defibrillator (ICD) leads were much more likely than those made by Boston Scientific or Medtronic to fail due to internal insulation breaches (IBR).

Researchers at the Minneapolis Heart Institute Foundation combed through the FDA MAUDE database from 2008 to 2018 for reports of IBR breaches and other ICD failures. They found that insulation breaches led to 93% of Abbott’s (formerly St. Jude Medical’s) Durata pacemaker lead failures. All 11 failures to treat ventricular tachycardia/ventricular fibrillation were caused by high-voltage shorts between the proximal and distal right ventricular coil cables or sensing conductor. Testing showed low values of high-voltage impedance in three of the leads after a shock or an aborted shock or by an alert, they wrote in an article published in the journal Heart Rhythm.

Get the full story on our sister site, Medical Design & Outsourcing.

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BTG shareholders OK $4B Boston Scientific buyout

Boston Scientific acquires BTGBTG (LON:BTG) said yesterday that its shareholders voted to approve a more than $4 billion buyout offer by Boston Scientific (NYSE:BSX) and affirmed that the deal is on track to close mid-year.

The British medical device maker said that some 95.4% of the shareholders affected by the tie-up voted for the deal, with 4.6% of those shares voting against. Overall, the votes to approve the merger amounted to 62.4% of total BTG shares and the votes against were 0.03%, BTG said.

Earlier this week Marlborough, Mass.-based Boston Scientific said it closed a $4.3 billion debt round it plans use to defray the cost of buying BTG.

The £8.40-per-share offer, worth about $4.24 billion (£3.3 billion), is slated to close in mid-2019. The purchase price is a 36.6% premium over BTG’s closing price the day before the Nov. 20 announcement and a 51.0% premium over the stock’s 90-day volume-weighted average price.

BTG’s largest division makes devices for oncology and vascular conditions; the company also makes overdose and antivenin drugs for snakebite.

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Study of Boston Scientific’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years

Medtronic, Boston Scientific

Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products.

The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system.

Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices.

Patients, treated between September 22, 2014 and December 24, 2015, were randomized two to one to receive the Lotus valve or CoreValve system at 55 centers spanning North America, Australia and Europe, according to study results.

Main outcomes being explored by researchers were all-cause mortality and all-cause mortality or disabling stroke at two years. Other factors examined included overall stroke, disabling stroke, repeat procedures, rehospitalization, valve thrombosis and pacemaker implantation.

At two years, results indicated similar rates of all-cause mortality, mortality and disabling stroke between the competing valve devices, according to the study results.

All-cause death was reported at 21.3% with the Lotus valve, versus 22.5% with the CoreValve, while rates of all-cause mortality or disabling stroke were 22.8% with the Lotus and 27% with the CoreValve. Rates of overall stroke were 8.4% with Boston Scientific’s Lotus offering, and 11.4% with Medtronic’s CoreValve.

Disabling stroke rates were higher for patients treated with the CoreValve at 8.6% versus a lower 4.7% with the Lotus device, while more Lotus patients were likely to receive pacemakers than those treated with the CoreValve at 41.7% versus 26.1%, according to the results.

“Disabling stroke, functional class, valve migration, and PVL favored the Lotus arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation favored the CoreValve arm,” research investigators concluded.

Patients in the trial will be followed out to five-years post procedure, investigators said.

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Boston Scientific closes $4B debt offering for BTG buyout

Boston ScientificBoston Scientific (NYSE:BSX) said yesterday that it closed a $4.3 billion debt round it plans use to defray the cost of buying BTG (LON:BTG)

The Marlborough, Mass.-based medical device company said the flotation comprised $850 million worth of 3.45% notes due 2024, $850 million in 3.75% notes due 2026, $850 million of 4.0% notes due 2029, $750 million of 4.55% notes due 2039 and $1.0 billion of 4.70% notes due 2049.

Apart from covering some of the $4.24 billion BTG buyout, which is slated to close mid-year, Boston Scientific said it also plans to use the proceeds to redeem a collective $1.18 billion in notes due 2020 and pay down some of a $1 billion term loan and other short-debt.

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