Boston Scientific Corp. said it is initiating a global, voluntary recall of all unused inventory of the Lotus Edge aortic valve system, blaming complexities associated with the product delivery system. The Marlborough, Mass.-based company emphasized that the valve itself continues to achieve positive and clinically effective performance post-implant. However, because of the time and investment needed to develop and reintroduce a delivery system, the company believes it is necessary to retire the entire Lotus platform immediately.

The history of TAVR devices is evolutionary as much as it is revolutionary, or that is at least the take-away from an Oct. 15 virtual session comparing the Acurate Neo device by Boston Scientific Corp., of Marlborough, Mass., with the Corevalve Evolut R by Dublin-based Medtronic plc.

Medtronic plc has kicked off two clinical trials of its Evolut transcatheter aortic valve replacement (TAVR) system. One study will pit the self-expanding Evolut Pro and Pro+TAVR systems against Edwards Lifesciences Corp.’s balloon-expandable Sapien 3 and Sapien 3 Ultra transcatheter heart valves in small annulus patients.

The annual publication of the draft Medicare physician fee schedule (MPFS) is an event, but this year’s draft has drawn substantial criticism from across the board, despite the promise of more coverage of telehealth. The Medical Imaging & Technology Association (MITA) and a coalition of surgeons have blasted the draft as a hazard to patient access to both evaluation and management (E/M) services and surgical procedures, both of which present substantial headwinds for the medical device industry.

Edwards Lifesciences Corp. reported better-than-expected results when it released its second quarter earnings late July 23, with revenue down 15% to $924 million, from $1.1 billion in the same period of 2019. The results beat Wall Street consensus of $797.5 million, and reflected an uptick in surgical procedures that had been delayed by the COVID-19 pandemic. The Irvine, Calif.-based company sustained a net loss of $121.9 million, or $0.20 per share, based on generally accepted accounting principles (GAAP), a sharp drop from $242.3 million, or $0.38 per share, in the same quarter last year. However, adjusted earnings looked brighter at $0.34 per share.

Startup Foldax Inc. has raised a $20 million series D round to back its development of biopolymer-based surgical and minimally invasive heart valves. Heart valves typically are either based on porcine or bovine tissues or are mechanical.

Medical science continues to define the relative risks of progressively smaller patient subsets across the disease spectrum, but this is particularly true of late in connection with aortic stenosis (AS).

BEIJING – Suzhou, China-based Peijia Medical Co. Ltd. became the second prerevenue med-tech company to go public on the Hong Kong Stock Exchange (HKEX) after Venus Medtech (Hangzhou) Inc., pocketing HK$2.3 billion (US$302 million) with an aim to develop and commercialize its transcatheter valve therapeutic medical device called Taurusone.

Pi-Cardia Ltd. has raised a $27 million round of financing led by Sofinnova Partners. The Rehovot, Israel-based company will use the round to back parallel U.S. feasibility and European pivotal trials of its catheter-based, nonimplant heart valve calcification treatment.

Physicians who perform a variety of device implant procedures face a difficult choice in determining whether a patient should be treated. A new article in the Journal of the American College of Cardiology (JACC) recommends that patients who ordinarily would be candidates for surgical aortic valve replacement (SAVR) might instead be referred for the transcatheter alternative.