Sorin Group Announces First North American Implant of the Freedom Solo Pericardial Aortic Valve
Designed to maximize hemodynamic performance and ease of implantation, Freedom Solo represents the first implant in the Canadian Investigational Testing Authorization clinical study. Additional Canadian investigational sites are scheduled to begin implanting the Freedom Solo pericardial aortic valve.
Pericardial aortic valves are typically constructed from bovine pericardial tissue. Currently available bovine pericardial valves have demonstrated in multiple peer-reviewed clinical papers that they can provide improved hemodynamic performance and long-term durability.
Introduced in Europe in 2004, Freedom Solo is the natural evolution of the Freedom valve which has been on the market since 1991. Implanted using a proven single-suture line technique, the Freedom Solo can be safely implanted in under 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 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 first North American implant of Freedom Solo was performed on a 65-year male patient by Pierre Voisine, MD, cardiac surgeon, Hopital Laval. “The unique design and implantation technique of the Freedom Solo valve are very exciting. Low gradients can be expected from a stentless valve with supra annular positioning, and Solo could be the prosthesis of choice in the vast majority of patients”, said Dr. Voisine.
"We are very excited about these implants, the first in North America of the Freedom Solo valve, a next-generation aortic valve that has demonstrated its outstanding hemodynamic performance, durability, and ease of implant through years of clinical performance in Europe," said Davide Bianchi, President of the Heart Valves BU. "We are proud to begin implants of the Freedom Solo valve in North America, with this unique technology providing an excellent alternative to physicians managing the care of patients with aortic valve disease. The Freedom Solo continues our legacy of providing surgeons with market-leading heart valve options”, added Davide Bianchi.
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 that include: 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.
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