Sorin Group Announces First Implant in U.S. Study of Stentless Pericardial Aortic Valve
Milan, Italy, 21 February, 2012 –Sorin Group, (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, today announced 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, M.D., F.A.C.S, the study’s principal investigator.
The 8-center, 300-patient U.S. study trial is designed to assess the safety and effectiveness of the Freedom Solo Stentless valvefor 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 hemodynamic performance, durability and ease of implant through years of clinical performance.
Implanted using a proven single-suture line technique, 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, 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 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”.
About Sorin Group
Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,700 employees worldwide, Sorin Group focuses on three major therapeutic areas: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management, and heart valve repair and replacement. Every year, over one million patients are treated with Sorin Group devices in more than 80 countries.
For more information, please visit www.sorin.com, or contact:
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