Sorin announced on 21 February 2012 initiation of a United States investigational device exemption (IDE) study for its Freedom Solo Stentless Pericardial aortic valve. The first patient was enrolled in the Freedom Solo IDE study at St Vincent’s Heart Center of Indiana in Indianapolis by David Heimansohn, the study’s principal investigator.
The eight-centre, 300-patient study trial is designed to assess the safety and effectiveness of the Freedom Solo Stentless valve for patients with symptomatic aortic stenosis.
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 has demonstrated outstanding haemodynamic performance, durability and ease of implant through years of clinical performance, Sorin claims.
Implanted using a proven single-suture line technique, Freedom Solo can be safely implanted within 20 minutes. The Freedom Solo’s stentless design utilises two pericardial sheets constructed to maximise leaflet opening and closing. 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.
“The Freedom Solo valve provides superior haemodynamics and is much easier to implant than stented valves. This valve will change the way we do surgical aortic valve replacement”, said Heimansohn.