Feops SA reported that its Heartguide product has received de novo authorization from the FDA for pre-operative planning of left atrial appendage occlusion (LAAo) with the Boston Scientific Corp. Watchman device. The software platform is designed to help physicians virtually model clinical scenarios with different implant positions and sizes of the Watchman device using digital twin technology based on patient-specific virtual replicas of the heart. It is currently commercially available in the EU, U.K., Canada and Australia for transcatheter aortic valve implantation and LAAo workflows.
The Ernst & Young Pulse of the Industry 2021 report outlined several ways med-tech companies can benefit from fundamental changes in business wrought by the pandemic to build a stronger foundation for the future. While the need for more agile supply chains and the drive to measure social and environmental impact as well as financial metrics have affected all economic sectors, COVID-19 transformed the med-tech industry in specific ways that could have long-lasting impact.
Boston Scientific Corp. agreed to acquire the Baylis Medical Company Inc.’s cardiology business, Baylis Medical Co., for an upfront payment of $1.75 billion, subject to closing adjustments. The transaction is expected to close in the first quarter of 2022. Baylis Medical Technologies, which focuses on radiology and neurosurgery, is not part of the deal and will remain a separate entity.
The FDA posted an advisory for health care professionals regarding a “potential for differences” between men and women in connection with the use of left atrial appendage (LAA) closure devices. The agency said that differences in procedural outcomes as described in a new medical journal article included a procedure-associated death rate of 0.3% among women undergoing the procedure, triple the rate of 0.1% in men.
Boston Scientific Corp. has said pressure from the Delta variant in the U.S. means it is unlikely to hit the lower end of its current third-quarter sales guidance, which calls for 12% to14% organic growth vs. Q320 and 5% to 7% organic growth vs. Q319. Boston Scientific said it expected to still hit the full year sales guidance of 6% to 7% organic vs. 2019 that it issued on July 27 but would continue to monitor the economic and financial impacts of COVID-19. The company noted that the impact of Delta had been mostly in the NW and SE parts of the U.S. while the impact in EU/APAC region had been more modest.
Boston Scientific Corp. grabbed the remaining shares of Devoro Medical Inc. and its Wolf thrombectomy platform in a transaction valued at $269 million. Freemont, Calif.-based Devoro stands to gain an additional $67 million if the company achieves undisclosed clinical and regulatory milestones. Boston Scientific began investing in Devoro in 2019 and currently holds 16% of Devoro. The deal, the Marlborough, Mass.-based company’s fourth major transaction since the start of the second quarter, is expected to close by the end of the year. It follows the acquisitions of Preventice Solutions Inc., of Rochester, Minn., for $1.225 billion in April, which added to the company’s cardiac wearables, and Menlo Park, Calif.-based Farapulse Inc. for $295 million in June, to build out its cardiac ablation position. Boston Scientific purchased Yokneam, Israel-based Lumenis Ltd. for $1.07 billion, in a transaction that just closed three weeks ago.
Nectero Medical Inc. has secured $19.5 million in a series C financing round, led by Boston Scientific Corp. The company is developing the Endovascular Aortic Stabilization Treatment (EAST) system, a treatment platform that reduces the growth rate of aortic aneurysms. EAST is currently in a multisite phase I safety study for abdominal aortic aneurysm (AAA) patients and the financing will be used to fund further in vivo and clinical development.
The race is on. After six years as the only FDA approved devices for left atrial appendage closure, Boston Scientific Corp.’s Watchman products face a challenger, Abbott Laboratories’ Amplatzer Amulet. With the Amulet’s FDA approval in mid-August and positive results in a head-to-head trial presented at the 2021 European Society of Cardiology Congress on Tuesday, the Watchman has reason to look over its shoulder at a competitor that could change the game entirely. The trial results were published simultaneously in Circulation.
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.
