Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation.

The new technology add-on payment for the TAG thoracic branch endoprosthesis is likely coming to an end, but the device’s manufacturer, Gore Medical Inc., petitioned CMS to reassign the procedure to a new diagnostic-related group that would more accurately reflect the costs of the related procedure.

In the wake of the pandemic, many leading med-tech companies took steps to on-shore and near-shore manufacturing, a move that could protect significant numbers of players from the worst of the effects of the tariffs announced by the Trump administration last week.

Don’t wait. Edwards Lifesciences Corp.’s additional insights from the Early TAVR trial showed a clear benefit for transcatheter aortic valve replacement (TAVR) in patients with asymptomatic aortic stenosis.

Medtronic plc’s Evolut Low-Risk trial continued to show non-inferiority of transcatheter aortic valve replacement to surgical aortic valve replacement in terms of death or disabling stroke at five years in a late-breaking presentation at the American College of Cardiology’s Annual Scientific Session in Chicago on March 30.

The final U.S. Medicare national coverage determination for transcatheter tricuspid valve replacement (TTVR) devices comes with an expected coverage with evidence development mandate, but some analysts expect that TTVR devices will face competition from tricuspid transcatheter edge-to-edge repair (T-TEER) devices, the subject of an impending national coverage analysis.

Medtronic plc released positive results from a two-year trial of Evolut TAVR that demonstrated superior valve performance in patients with small aortic annuli.

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.

The U.S. national coverage analysis for transcatheter tricuspid valve replacement drew support from cardiologists and device makers alike, but the Medical Device Manufacturers Association is urging CMS to plan ahead in its final coverage memo and consider the coverage needs outside the confines of the existing U.S. FDA-approved device.

To say that European investors are optimistic about the outlook for the med-tech sector in 2025 is an understatement. A couple of companies are already listed on public markets, acquisitions have been undertaken and med-tech players with cash-rich balance sheets are on the hunt.