Sorin Group announced that it will be completing the study of FREEDOM SOLO by April 2014.
Freedom Solo is biological aortic valve with haemodynamic characteristics that is designed for native aortic leaflet replacement only. This is a stentless valve constructed from two pericardium sheets with no fabric reinforcement that helps in the case of active endocarditis. It has high biocompatibility and is easy to implant. It has no rigid support.
This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
The 700 patient study is currently recruiting participants. The official title of the trial is “Clinical Investigation of the Freedom SOLO Stentless Heart Valve”.