Data from the first-in-human study of Tricares SAS Topaz transcatheter tricuspid valve replacement (TTVR) system, showed it significantly reduced tricuspid regurgitation (TR) in patients treated with the device. The early clinical data at 30 days demonstrated that all patients implanted with Topaz were at a TR grade ‘none’ (0+) or ‘mild’ (1+) following the procedure.
The U.S. FDA’s approval of the Abbott Laboratories Triclip was predicated on a data set comprised of 350 patients, but an additional bolus of data seems to reinforce the rationale for the FDA approval, including improvements in quality of life.
Croívalve Ltd. raised $16 million in a series B financing round that will be used to fund a clinical trial in the U.S. looking at the safety and performance of its Duo system to treat patients with severe or greater symptomatic tricuspid regurgitation.
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.
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.
Results from the largest trial yet in transcatheter valve replacement continues to demonstrate strong results for Edwards Lifesciences Corp.’s Evoque system. A late-breaking presentation at the PCR London Valves 2022 meeting provided one-year follow-up results from the Triscend study showing better than 90% survival and 99% freedom from heart failure hospitalization. Further, 97.6% of patients maintained mild or trace tricuspid regurgitation.
Venus Medtech (Hangzhou) Inc. reported it has acquired 100% equity interest and corresponding equity in Cardiovalve Ltd. for $300 million. Or Yehuda, Israel-based Cardiovalve produces the Cardiovalve system, a transcatheter interventional replacement product for mitral or tricuspid regurgitation.
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.
