Edwards Lifesciences Corp., of Irvine, Calif., petitioned the Centers for Medicare & Medicaid Services to revise the Medicare coverage policy for transcatheter aortic valve replacement (TAVR) devices on two points, the combination of which would make a big difference for TAVR devices across manufacturers. Edwards requested that CMS explicitly cover TAVR for asymptomatic aortic stenosis patients, a notion well supported by recent data, and bring an end to the coverage with evidence development mandate.

The U.K. National Institute for Health and Care Excellence has recommended that physicians in the U.K. use the least expensive, clinically appropriate TAVR device when possible, concluding a pricing review that commenced roughly a year ago.

The U.S. Federal Trade Commission (FTC) reported Aug. 6 that it will try to block Edwards Lifesciences Corp.’s proposed acquisition of Jenavalve because Edwards’ acquisition of both Jenavalve Technology Inc. and JC Medical would eliminate competition in the TAVR space for aortic regurgitation.

Edwards Lifesciences Corp.’s posted fourth quarter results slightly ahead of expectations, but indicated that the first quarter of 2025 might not be as bright. The company expects growth for both its lead transcatheter aortic valve replacement (TAVR) business and the company to fall below its full-year estimates, with a mid-year indication expansion for TAVR providing a critical boost in the back half of 2025.

At its investor day conference, Edwards Lifesciences Corp. prognosticated that an expanded indication in transcatheter aortic valve replacement and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.

Andera Partners involvement in a string of recent deals in the cardiovascular space demonstrates the ongoing appetite for devices to treat heart diseases, Olivier Litzka, a partner at Andera Partners told BioWorld.

Edwards Lifesciences Corp. continued its recent acquisition streak with its buy of JC Medical Inc., a subsidiary of Genesis Medtech International. The sale included the intellectual property and commercial rights for the J-Valve system, a transcatheter aortic valve replacement for the treatment of severe aortic regurgitation.

It’s a quad-pack for Edwards Lifescience Corp. as it reported its third and fourth deals this month – agreements to buy Jenavalve Technology Inc. and Endotronix Inc. for a combined up-front cost of about $1.2 billion plus up to $445 million in contingent milestone payments.

Andera Partners closed its Biodiscovery 6 fund at €456 million (US$442 million). The venture capital firm will maintain its custom of allocating about two-thirds of the fund to biotechnology and one-third to medical devices and medical technology. The fund just edges past its target of €450 million. It is considerably larger than its immediate predecessor, Biodiscovery 5, which raised €345 million.

Jenavalve Technology Inc. presented first real-world data for a study evaluating the safety and efficacy of its Jenavalve Trilogy transcatheter aortic valve implantation (TAVI) system for the treatment of severe aortic regurgitation (AR). The data, presented at the EuroPCR meeting on May 18, met the primary safety and efficacy endpoints with no major adverse events and no moderate or severe AR at discharge.