“The Freedom Solo valve has demonstrated unmatched hemodynamic performance, durability and ease of implant through years of clinical experience in Europe”
Italian Cardiovascular company Sorin Group, has announced the first patient in its United States investigational device exemption (IDE) study has received its Freedom Solo™ Stentless Pericardial aortic valve.
According to a company news release, the Freedom Solo prosthesis is indicated for the replacement of diseased native aortic heart valves or malfunctioning prostheses. Introduced in 2004 in Europe, Freedom Solo is a next-generation aortic valve that Sorin claims has demonstrated outstanding haemodynamic performance, durability and ease of implant through years of clinical performance.
The IDE study comprises an 8-centre, 300-patient U.S. trial, designed to assess the safety and effectiveness of the Freedom Solo Stentless valve for patients with symptomatic aortic stenosis.
The first patient was enrolled in the Freedom Solo IDE study at St. Vincent’s Heart Center of Indiana in Indianapolis by David Heimansohn, M.D., F.A.C.S, the study’s principal investigator.
Implanted using a proven single-suture line technique, Sorin says Freedom Solo can be safely implanted within 20 minutes. The Freedom Solo’s stentless design utilizes two pericardial sheets constructed to maximize leaflet opening and closing. Implanted in the supra-annular position, the company claims that 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 haemodynamic performance.
“The Freedom Solo valve provides superior hemodynamics and is much easier to implant than stented valves. This valve will change the way we do surgical aortic valve replacement”, said David Heimansohn, M.D., F.A.C.S. St. Vincent’s Heart Center of Indiana, Indianapolis.
“The Freedom Solo valve has demonstrated unmatched hemodynamic performance, durability and ease of implant through years of clinical experience in Europe,” said Davide Bianchi, President of the Heart Valves BU. “We are excited to bring this technology to the US market”.
Source: Sorin Group