Abbott announced that it received a Medicare win related to its TriClip TEER system. In a LinkedIn post, the company’s Cardiovascular unit wrote that the Centers for Medicare and Medicaid Services (CMS) released a National Coverage Determination (NCD) and coverage conditions for tricuspid transcatheter edge-to-edge repair (T-TEER) for tricuspid regurgitation (TR). That included the company’s […]
Replacement Heart Valves
Caranx Medical surgical robot TaviPilot AI software wins FDA clearance
The FDA has granted 510(k) clearance to the TaviPilot AI software developed by Caranx Medical, according to company officials. Pierre Berthet-Rayne, the company’s co-founder and chief technology officer, announced the clearance on LinkedIn. Nice, France-based Caranx Medical developed its TaviPilot robotic solution for aortic valve replacement. The robot can make an artery puncture and then, […]
MiRus reports positive early feasibility data for heart valve
MiRus announced new early feasibility study results supporting the use of its Siegel transcatheter aortic valve replacement (TAVR) system. Dr. Pradeep Yadav (Piedmont Heart Institute) and Dr. Raj Makkar (Cedars Sinai) presented findings in podium presentations at NY Valves. Thirty-day results came from the company’s U.S. early feasibility study (EFS). MiRus announced the start of […]
CroíValve picks up new funding from European accelerator
CroíValve announced today that it received new funding from Horizon Europe’s European Innovation Council (EIC) Accelerator Program. EIC awarded the funding as part of the EU’s Horizon Europe 2021-2027 Research and Innovation Program. It provides funding to high-potential, high-risk startups, scale-ups and subject matter experts. The competition included 959 applicants for 40 awards across 16 […]
Foldax presents positive polymer heart valve data
Foldax today announced one-year results from a clinical trial of its Tria polymer mitral heart valve offering. In a trial based in India, the mitral valve demonstrated a good safety profile and sustained hemodynamic performance. Investigators reported a statistically significant improvement in patient quality of life. “These results validate our strategy of taking heart valve therapy […]
Court sides with Cardiovalve in Edwards patent spat
The U.S. Court of Appeals for the Federal Circuit has taken Cardiovalve’s side after Edwards argued certain heart valve patent claims were invalid. In a final written decision, the U.S. Patent Trial and Appeal Board (PTAB) granted Cardiovalve’s non-contingent motion to amend and supplemental motion to amend, canceling original claims in U.S. Patent No. 10,702,385. […]
Foldax gets India approval for polymer mitral heart valve
Foldax this week announced it secured regulatory approval in India for its Tria mitral heart valve. The approval from India’s Central Drugs Standard Control Organization allows Dolphin Life Science to produce the valve locally. It is the first commercial approval of a polymer heart valve anywhere in the world, according to the company. Foldax designed […]
Designer of the first artificial heart Robert Jarvik passes away
The New York Times reported last week that Dr. Robert K. Jarvik, who led the development of the first artificial heart, passed away. He died last Monday at his home in Manhattan at the age of 79, according to the report. His wife, Marilyn vos Savant, told The New York Times that he died of […]
BiVacor wins FDA breakthrough nod for Total Artificial Heart
BiVacor announced today that it received FDA breakthrough device designation for its Total Artificial Heart (TAH) system. The designation supports the TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including LVADs, are not viable. “This is more than a regulatory milestone. It’s a validation […]
FDA approves Abbott mitral valve replacement device that doesn’t require open-heart surgery
Abbott announced today that it received FDA approval for its Tendyne transcatheter mitral valve replacement (TMVR) system. The TMVR system offers an option for patients with mitral valves that fail to function properly due to severe mitral annular calcification (MAC). MAC stiffens the annulus ring-like structure that supports the mitral valve. This can lead to […]
The biggest cardiovascular tech news out of EuroPCR 2025
This week, a number of companies, big and small, shared updates on their cardiovascular technology innovations at EuroPCR 2025 in Paris. The latest edition of EuroPCR delivered updates on technologies like intravascular lithotripsy (IVL), replacement heart valves, drug-eluting stents and many, many more innovative offerings. Usual suspects in the cardiovascular space like Edwards, Johnson & […]
