The U.S. FDA said the results of a Section 522 postmarket surveillance study of transvaginal mesh devices by Boston Scientific Corp. suggested similar effectiveness and safety outcomes at 36 months compared to native tissue repair. However, the agency said patients with mesh repair for pelvic organ prolapse (POP) are exposed to additional risks, such as mesh exposure and erosion, and thus the agency is disinclined to allow these devices back onto the market.
The FDA reported that Boston Scientific Corp. has recalled several models from the Ingenio line of cardiac electrophysiology devices in a class I action that affects 48,000 devices. The recall was triggered by the risk that these devices will inappropriately shift into safety mode and thus be unable to provide pacing, as demonstrated by 65 such incidents and three instances in which patients needed external pacing in response to the problem.
The annual scramble for elevated payment rates under the U.S. Medicare inpatient rule has concluded, and at least one artificial intelligence product came up short in its bid for a new technology add-on (NTAP) payment. However, Medtronic plc, Boston Scientific Corp. and Cook Medical Inc. all secured or sustained NTAP payments for products that are critical for patients with a variety of life-threatening conditions, such as severe pulmonary valve regurgitation in pediatric patients.
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.
