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.
On March 1, Boston Scientific Corp.’s Agent drug-coated balloon (DCB) became the first DCB to gain U.S. FDA approval for treatment of in-stent restenosis in patients with coronary artery disease. With more than 100,000 patients already treated in Europe, Latin America and Japan, it’s no secret Agent provides significant benefit compared to balloon angioplasty or drug-eluting stents (DES) for the approximately 10% of patients with coronary stents who experience subsequent narrowing of the treated vessel.
Boston Scientific Corp. notched another win with the U.S. FDA approval of its spinal cord stimulator (SCS), Wavewriter, for treatment of non-surgical back pain just a week after receiving the agency’s nod for its Farapulse pulsed field ablation system. The new indication comes four months after expansion of approved uses for Wavewriter to include painful diabetic peripheral neuropathy.