Sorin Group has enrolled the first patient in the US investigational device exemption (IDE) study for its freedom solo stentless pericardial aortic valve.
The study trial, which is to be conducted at eight centres, will include 300-patients and evaluate the safety and efficacy of the freedom solo stentless valve for patients with symptomatic aortic stenosis.
Indicated for the replacement of diseased native aortic heart valves or malfunctioning prostheses, the freedom solo prosthesis can be implanted in 20 minutes using a single-suture line technique. The device is implanted in the supra-annular position and uses two pericardial sheets, constructed to maximise leaflet opening and closing.
Freedom solo will reduce the risk of mismatches between the annulus of the patient and the size of the valve, according to the Sorin Group. The study's principal investigator David Heimansohn said 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," David Heimansohn added.
Heart Valves BU president Davide Bianchi said the freedom solo valve has demonstrated unmatched hemodynamic performance, durability and ease of implant through years of clinical experience in Europe.
"We are excited to bring this technology to the US market," Bianchi added.
Introduced in 2004 in Europe, the next-generation aortic valve has demonstrated hemodynamic performance, durability and ease of implant through years of clinical performance.