Sorin Group has started an investigational device exemption (IDE) study of its Freedom Solo Stentless Pericardial aortic valve in the US.
The study, which enrolled 300 patients, is designed to evaluate the safety and effectiveness of the Freedom Solo Stentless valve in patients with symptomatic aortic stenosis.
The Freedom Solo is used to replace the diseased native aortic heart valves or malfunctioning prostheses.
Freedom Solo’s stentless design which uses two pericardial sheets constructed to maximize leaflet opening and closing, is safely implanted with in a period of 20 minutes using a proven single-suture line technique.
Implanted in the supra-annular position, Freedom Solo greatly reduces the risk of mismatch between the annulus of the patient and the size of the valve and provides the patient with best-in-class hemodynamic performance.
Heart Valves BU president Davide Bianchi said the Freedom Solo valve has showed unmatched hemodynamic performance, durability and ease of implant through years of clinical experience in Europe.