Abbott Laboratories reported the U.S. FDA approval of a new device specifically designed for the repair of leaky tricuspid heart valves. The Triclip was granted a PMA for the treatment of tricuspid regurgitation following the recent recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee for the FDA, whose vote confirmed 13 to 1, with 0 abstention that the benefits of Triclip outweighed the risks.
Just in time for Valentine’s Day, the circulatory system devices panel of the medical devices advisory committee for the U.S. FDA showed some love for Abbott Laboratories’ Triclip transcatheter edge-to edge repair (TEER) system for leaky tricuspid heart valves.
Edwards Lifesciences Corp. received some good news with the earlier-than-expected U.S. FDA approval of its Evoque tricuspid valve replacement system. The company beat out rival Abbott Laboratories for the honor of being the first transcatheter therapy to receive FDA approval.
Abbott Laboratories Inc. reported late-breaking data from the Bright study which showed that its Triclip transcatheter edge-to-edge repair (TEER) system reduced tricuspid regurgitation and improved the quality of life of patients with leaky tricuspid valves. The results from the largest real-world dataset were presented, for the first time, at the EuroPCR 2023 conference in Paris.
Tricuspid valve regurgitation has lagged mitral regurgitation where device development is concerned, but new one-year data from the TRILUMINATE study of the Triclip device suggests that device therapy is safe and cuts down on regurgitation in a manner that makes the condition much more tolerable for patients. At this point, however, the data do not yet offer much difference when it comes to mortality and rehospitalization compared to medical management, a gap Abbott will have to overcome if it wants to maximize its investment in this underdeveloped area of medical technology.
The use of leads for cardiac electrophysiology devices has proven nothing short of controversial in the past, usually an artifact of efforts to craft ever-skinnier leads that won’t disrupt the blood vessels into which they are placed. Dublin-based Medtronic plc is working to avoid these problems with leads without sacrificing the advantages of leads via its EV ICD system, which soundly passed the test in a study presented at this year’s edition of the European Society of Cardiology (ESC) annual scientific sessions.
Abbott Laboratories Inc. reported 30-day results from its Triclip Bright Study at the EuroPCR meeting in Paris on May 19. The real-world outcomes showed that the company’s tricuspid repair systems Triclip and Triclip G4 transcatheter edge-to-edge repair (TEER) significantly reduced tricuspid regurgitation (TR) and substantially improved the quality of life across a wide range of anatomically diverse patients.
Minimally invasive structural heart implants are moving from mitral into tricuspid valve repair, as well as mitral valve replacement. Abbott Laboratories is presenting its latest data on all these fronts at the virtual PCR e-Course held by the European Association of Percutaneous Cardiovascular Interventions from June 25 to 27.
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.