Boston Scientific Archives - Page 12 of 19

Boston Scientific touts Watchman FLX trial data

[Image from Boston Scientific]Boston Scientific (NYSE:BSX) today touted positive 24-month results from a trial evaluating its Watchman FLX left atrial appendage closure device.

Marlborough, Mass.-based Boston Scientific’s Watchman FLX LAAC device for patients with non-valvular atrial fibrillation (NVAF) has previously proven its safety and efficacy in 12-month data from the same trial presented in April.

The latest data, presented as late-breaking clinical science at TVT: The Structural Heart Summit, evaluated Watchman FLX as an alternative to long-term oral anticoagulation therapy, including non-vitamin K antagonist oral anticoagulants (NOACs) fo stroke risk reduction in patients with NVAF, according to a news release.

Pinnacle FLX, a 400-patient trial in the U.S. met its secondary effectiveness endpoint, having already met primary safety and efficacy endpoints in the 12-month data from earlier this year. Watchman FLX hit the endpoint, defined as the…

The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news release.

Nominees need to be FDA-approved for the market within the last five years a…

MedTech 100 roundup: Nearing new highs once again

Having hit a downturn as the summer neared, the medtech industry is now consistently on the rise as June comes to a close.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 25) at 113.42 points, producing a 2.5% rise from the 110.64-point mark set one week prior (June 18). In all, the industry has risen 5.9% over the past three weeks.

The recent upswing shows no signs of slowing after the industry’s progress came to a halt with a -1.4% dip earlier this month. The index looks set to close in on the 114.58-point mark set in April, marking the industry’s all-time best performance.

Even with some recent setbacks, medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 22.9% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 82.6% increase from the mid-pandemic low …

Boston Scientific pulls trigger on Farapulse acquisition

Boston Scientific (NYSE:BSX) announced today that it exercised its option to acquire the remaining shares of Farapulse.

Marlborough, Mass.-based Boston Scientific first announced its intent to acquire Farapulse when it signed an investment agreement with an option to acquire the pulsed-field ablation (PFA) technology developer in September 2020.

Boston Scientific has been an investor in Farapulse since 2014 and currently holds an equity stake of approximately 27%. The transaction to acquire Farapulse includes an upfront payment of approximately $295 million for the 73% stake not yet owned, plus up to $92 million upon the achievement of certain clinical and regulatory milestones and additional revenue-based payments over the next three years, according to a news release.

The company said that, preceding consideration of current equity ownership, debt and other closing adjustments, the total transaction price amounts to $450 million upfront, up to $125 mil…

Barclays is bullish on medtech

Barclays analysis projects that medtech might be on its way to a stretch of “outperformance” even in the wake of the COVID-19 pandemic.

According to SeekingAlpha, the report cited eight reasons that make the investment bank bullish on the industry in the coming years, starting with what it calls “robust innovation.”

On top of the evolving innovation in medtech, Barclays expects the canceled procedures of 2020 (as a result of COVID-19) to return, while new technology could increase diagnoses.

Direct-to-consumer advertising, a potential return to “normality” in a post-pandemic scape, surveys indicating a resurgence in elective surgeries, healthy balance sheets and an aging population as a tailwind round out the reasons why Barclays expects success for medtech over the next several years.

Medtech companies that Barclays stands “overweight on” include Abbott (26.72% upside), Boston Scientific (18.55% ups…

Boston Scientific gets CE mark approval for single-use bronchoscope

Boston Scientific today said it received CE mark approval for its Exalt Model B single-use bronchoscope.

The Marlborough, Mass.-based company designed the device for bedside procedures in the intensive care unit, operating room and bronchoscopy suite.

Get the full story on our sister site, Medical Tubing + Extrusion.

Boston Scientific has a serious stent recall problem

The FDA announced today that it deemed Boston Scientific’s recall of its VICI SDS and VICI RDS venous stent systems as Class I, the most serious kind of recall.

Marlborough, Mass.-based Boston Scientific’s VICI SDS and VICI RDS venous stent systems treat obstructions and occlusions in narrowed or blocked venous veins.

According to the FDA notice, the company recalled the stent systems following reports indicating that they may migrate or move from where they are initially implanted.

If a stent migrates or moves from the initial implant location, it may require another surgery or catheter procedure to retrieve it, increasing the risk to the patient. Risks involved in this issue include possible damage to the blood vessel, heart walls or other organs, while migration of the stent to the heart could cause life-threatening injury, FDA said.

To date, there have been 17 complaints and reported injuries related to the issue of migration with …

Boston Scientific’s Acurate Neo performs well in latest trials

[Image from Boston Scientific]Boston Scientific (NYSE:BSX) touted positive results from multiple studies for its Acurate neo2 aortic valve system.

Marlborough, Mass.-based Boston Scientific presented results from the investigator-initiated Early neo2 Registry and ITAL-neo Registry studies at the EuroPCR 2021 meeting earlier this week, according to a news release.

Results from the Early neo2 Registry of 554 patients across 12 European centers showed a 1.3% post-operative moderate/severe paravalvular leakage (PVL) rate, which was lower than the rate observed in previous studies of the device. Mild and none/trace PVL rates registered at 33.3% and 65.4%, respectively.

Meanwhile, the study revealed a 6% permanent pacemaker implementation (PPI) rate, a 2.1% in-hospital stroke rate, a 1.3% mortality rate at 30 days, as well as excellent hemodynamics, according to Boston Scientific. Results demonstrated that the Acurate neo2 device was associated with significantly…

5 of the latest cardiac tech insights out of ACC.21

The American College of Cardiology’s 70th Annual Scientific Session has produced some positive news about some controversial cardiac tech.

Drug-coated stents, which a 2018 study linked to late-stage death, were shown to be non-inferior to non-drug-coated stents in patients with peripheral arterial disease. And a new study of renal denervation that used a different methodology showed significant progress in reducing high blood pressure.

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

DTW Podcast: Getting to the heart of Boston Scientific’s peripheral business; How Hologic sees trials changing

In this week’s episode of the DeviceTalks Weekly Podcast, Jeff Mirviss, executive vice president of Boston Scientific’s peripheral business, explains why the specialty’s name doesn’t really reflect the importance of arteries, veins and other critical “highways” that his business group is addressing.

Mirviss explains where the peripheral business is headed, and why Boston Scientific is uniquely positioned to address the business.

He also shares lessons learned over his 20-plus years at Boston Scientific including the challenges presented by the Guidant acquisition and the necessary spirit infused by CEO Michael Mahoney.

Also on this week’s podcast, Eric Kolodziej, corporate vice president and global head quality and regulatory affairs at Hologic, about how clinical trial management is changing. What role will real world evidence play going forward, and how will Hologic and others follow up on the record number of EUA’s issued over the past yea…

Boston Scientific initiates coronary drug-coated balloon study in U.S.

Boston Scientific (NYSE:BSX) this week launched its Agent IDE trial for its Agent drug-coated balloon.

The U.S. prospective, randomized clinical trial will evaluate the safety and effectiveness of a drug-coated balloon (DCB) in patients with coronary in-stent restenosis in lesions up to 26 mm in length in a coronary artery 2.0 mm to 4.0 mm in diameter.

It will evaluate the 12-month target lesion failure rate, defined as myocardial infarction related to the target vessel, the need for a revascularization procedure or cardiac mortality. The company said at least 480 patients will be enrolled in the study at 40 U.S. sites.

Get the full story on our sister site, Medical Tubing + Extrusion.

BWXT Medical, Boston Scientific forge agreement to manufacture TheraSphere microspheres

BWXT Medical announced today that it entered into a long-term, mutually exclusive agreement to manufacture Boston Scientific’s TheraSphere.

Ottawa, Ontario-based BWXT’s new deal with Boston Scientific covers manufacturing of the TheraSphere Y-90 glass microspheres from the Marlborough, Mass.-based medtech company.

TheraSphere treatment for patients with hepatocellular carcinoma (HCC) delivers millions of glass microspheres containing radioactive Yttrium-90 directly to liver tumors through a catheter with minimal exposure to surrounding healthy tissue, according to a news release.

Under the agreement, BWXT Medical, a subsidiary of BWX Technologies, will invest to automate the manufacturing process at its Ottawa facility in an effort to increase capacity and dependability to match the growing global demand for TheraSphere.

“We congratulate Boston Scientific on its recent receipt of FDA PMA approval of TheraSphere, which expands patient a…