FDA Advisors Vote That Benefits Of Abbott’s MitraClip Outweigh Risks
This article was originally published in The Pink Sheet Daily
The agency’s Circulatory System Devices Panel narrowly voted in favor of Abbott’s MitraClip transcatheter mitral valve repair system to reduce mitral regurgitation. But the discussions about the clinical evidence on the technology were complex and the panel’s support for Abbott’s PMA was not unanimous.
You may also be interested in...
Abbott to present data showing MitraClip is safer option for inoperable patients.
CMS held its annual new-technology Town Hall Feb. 5, hearing from applicants for a drug-eluting peripheral artery stent, a neurostimulator system for epilepsy seizures, a transcatheter mitral valve repair system and a retinal prosthesis system.
Former CMS coverage director Louis Jacques talks about the strong future ahead he envisions for the Medicare coverage-with-evidence-development program and new coverage policies that will be implemented for investigational device exemption trials.