FDA approves TMVR system for high-risk patients | Abbott reports climbing medtech sales | CMS considering major policy changes

The Sapien M3 transcatheter mitral valve replacement system is implanted using a transseptal approach. The device previously received CE mark approval in 2025.

Abbott pointed to double-digit growth for its Navitor TAVR valve as well as big gains for the TriClip and MitraClip devices. The company also shared positive sales figures for its EP, heart failure and rhythm management portfolios. 

Nick West, MD, Shockwave Medical's chief medical officer, detailed how the company is continuing to push IVL technologies forward. "We are leading the space ... we have no intention of giving up that position," he said.

CMS is considering substantial updates to its TAVR policies, including coverage for asymptomatic patients. Some stakeholders are excited, embracing the possibility of expanded indications and fewer restrictions. Others are concerned that the changes would be too much, too soon.

TAVR has already transformed care for patients with severe aortic stenosis. Will it make a similar impact on the treatment of aortic regurgitation?

Cardiologists now have a new tool to assist with PDA closure in these vulnerable patients.

The device at the heart of this transaction is the PerQseal Elite system, a fully bioabsorbable patch for percutaneous vessel closure. The technology has already gained key approvals in Europe. 

Three out of four TTEs are being ordered by clinicians who are not cardiologists. Could this be having a negative impact on patient care?