Croívalve Ltd. secured a further $20 million in series B financing for its Duo Adapt system, a transcatheter device that treats tricuspid regurgitation. The company also received $7 million from the European Innovation Council and the Disruptive Technologies Innovation Fund in grant financing. Croívalve will use the funds to expand its clinical study, which is evaluating the safety and performance of the Duo Adapt system in patients with severe or greater symptomatic tricuspid regurgitation.

Edwards Lifesciences Corp. raised its full-year 2026 guidance after seeing strong sales in the first quarter, particulalry from its transcatheter aortic valve replacement (TAVR) business. The company now expects sales growth of 9% to 11%, up from prior outlook of 8% to 10%, and adjusted earnings per share of $2.95 to $3.05, compared with earlier guidance of $2.90 to $3.05.

Polares Medical SA raised $50 million in a series C financing round for Mrace, its posterior leaflet replacement system designed to treat mitral regurgitation.

Medtronic plc acted on the increase in M&A and expansion of its investment ecosystem touted at the J.P. Morgan Healthcare Conference earlier this month with a $90 million infusion into Brisbane, Australia-based Anteris Technologies Global Corp. The investment had been contingent on a public offering of stock by Anteris, which it completed on Jan. 22. Together, the new funds for the biomimetic heart valve company totaled $320 million.

Affluent Medical SAS is becoming Carvolix after it entered into binding agreements to acquire Caranx Medical SAS for €16.6 million (US$19.34 million) and Artedrone SAS for €11.4 million. The aim is to create an integrated med tech company which will focus on revolutionizing cardiac valve replacement and stroke treatment through AI-driven autonomous mini-robots and innovative implants.

Edwards Lifesciences Corp. said it is scrapping plans to acquire Jenavalve Technology Inc. for $945 million after a federal court ruled against the company in a case brought by the U.S. Federal Trade Commission (FTC) to block the deal.

Edwards Lifesciences Corp. received U.S. FDA approval for its Sapien M3 mitral valve replacement system, making it the first transcatheter therapy utilizing a transseptal approach to be indicated for treatment of mitral regurgitation (MR). The Sapien M3 transcatheter mitral valve replacement system is indicated for the treatment of patients with symptomatic moderate-to-severe or severe MR or symptomatic mitral valve dysfunction who are deemed unsuitable for surgery or TEER by a multidisciplinary heart team.

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.

Edwards Lifesciences Corp. released data from a health economics study done across nine countries in Europe which showed that early transcatheter aortic valve replacement in patients with asymptomatic severe aortic stenosis can deliver significant economic benefits alongside improved clinical outcomes.