P+F Earns FDA Breakthrough Status for Transcatheter Heart Valve System

The FDA has granted Vienna, Austria-based P+F Products a Breakthrough Device designation for its TricValve Transcatheter Bicaval Valves system, a transcatheter heart valve intended to treat tricuspid valve regurgitation and inferior vena cava reflux.

The dual-valve system is being developed as a “potentially simple, relatively low-risk yet effective treatment” for patients with symptomatic severe tricuspid regurgitation and heart failure, the company said.

The valve is especially intended for patients who cannot be treated with open heart surgery. The company expects to receive the CE mark in the first quarter of 2021.