Sorin Group Announces First Implant in U.S. Study of Stentless Pericardial Aortic Valve
Sorin Group, a global medical company and a leader in the treatment of cardiovascular diseases, announces 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. Learn more at http://bit.ly/xyJ4Ez .