The FDA has granted breakthrough device designation to Micro Interventional Devices Inc. (MID) for its Mia-T percutaneous tricuspid annuloplasty system. The company will enjoy increased communication with the agency and priority review as it pursues regulatory approval.
Medtronic plc is celebrating its latest win following the U.S. FDA’s approval of an early feasibility study (EFS) of the Intrepid transcatheter tricuspid valve replacement system in patients with severe, symptomatic tricuspid regurgitation. The action comes after the agency granted breakthrough device designation for the system.
Edwards Lifesciences Corp. has gained a CE mark for its Pascal transcatheter valve repair system to treat tricuspid regurgitation (TR). It was previously approved for mitral regurgitation treatment. Due to the pandemic, Edwards has paused new enrollments in its ongoing mitral and tricuspid pivotal clinical trials.
Abbott Laboratories, of Abbott Park, Ill., reported that its Triclip transcatheter tricuspid valve repair system has received the CE mark. The device is a nonsurgical treatment for people with tricuspid regurgitation (TR), and, according to the company, it is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available. The Triclip is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood.
NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).
Abbott Laboratories has kicked off a pivotal study to evaluate its catheter-based Triclip transcatheter tricuspid valve repair system in patients with severe tricuspid regurgitation (TR). The first enrollments in the U.S. FDA-approved Triluminate study were performed at Abbott Northwestern Hospital in Minneapolis by a cardiac team led by Paul Sorajja, director of the Center for Valve and Structural Heart Disease at the Minneapolis Heart Institute and co-primary investigator for the trial.