Keystone Heart Ltd. had the unusual experience of being the sponsor of a rare class II device appearance before an FDA advisory committee, which considered whether the company’s Triguard 3 device was substantially equivalent (SE) to a predicate device. However, the company’s bid for an SE result was unsuccessful, likely leaving Keystone with a considerable additional regulatory lift before the company can get to market.
Boston Scientific Corp. has exercised an option as part of a 2020 agreement to acquire Farapulse Inc. in full, folding the startup’s pulsed electric field ablation technology for the treatment of atrial fibrillation and other cardiac arrhythmias into its own electrophysiology portfolio. With a 27% stake in Farapulse already, it will pay about $295 million for the remainder.
The controversy over the use of paclitaxel in devices for the peripheral vasculature has taken a significant bite out of sales, but a new study serves to help reverse the narrative regarding mortality. According to a study of more than 168,000 Medicare patients, stents and angioplasty balloons coated with paclitaxel (PTX) were non-inferior to non-coated devices for mortality out to nearly three years, a finding that may encourage clinicians to return to normal utilization patterns and thus help to restore sales volumes.
Boston Scientific Corp. presented late-breaking data at EuroPCR 2021 demonstrating positive procedural performance for its Acurate Neo2 aortic valve system, including low rates of paravalvular leakage (PVL) and permanent pacemaker implementation (PPI). The findings are good news, following the older Acurate Neo’s failure to demonstrate noninferiority to Medtronic plc’s Evolut R in the so-called SCOPE II study.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FCC says no need to revisit telehealth grants; NICE updates sphere usage for hepatocellular carcinoma; Health Canada: Docs, nurses not needed for workplace testing.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Evidence does not back hearing loss screening for asymptomatics; Boston Scientific settles on mesh marketing; FDA says approval phase for Barostim Neo was 240 days.
Boston Scientific Corp.'s Therasphere Y-90 glass microspheres received a PMA for treatment of patients with unresectable hepatocellular carcinoma (HCC). The radioembolization technique has been used in more than 70,000 patients under a humanitarian device exemption over the last 20 years. The U.K.'s NICE also recently recommended Therasphere for treatment of patients with HCC.
Boston Scientific Corp. has inked an agreement with an affiliate of Baring Private Equity Asia to acquire the global surgical business of Lumenis Ltd. for $1.07 billion up front. The med-tech giant has had a relationship with Lumenis for more than two decades and currently sells its urology laser portfolio in the U.S. and Japan. The transaction, expected to close in the second half of the year, expands Marlborough, Mass.-based Boston Scientific’s global urology footprint.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Task force gives CAS screening another thumbs down; USPTO expands program with Japan’s, South Korea’s patent offices; Boston Sci recalls electrode for ICD due to risk of fracture; CDSCO posts lists of approved tests.
Boston Scientific Corp. has received the U.S. FDA’s nod for its Synergy Megatron drug-eluting stent (DES) system. The company said the premarket approval makes Synergy Megatron the first platform in the U.S. that is designed for large, proximal vessels. The Synergy Megatron biopolymer (BP) stent is indicated “for improving coronary artery luminal diameter in patients with symptomatic ischemic heart disease, stable or unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in native coronary arteries.
