Sorin Group, (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the U.S. commercial launch of the Mitroflow Valsalva ConduitTM, the only Valsalva conduit graft approved by the U.S. Food and Drug Administration (FDA) for use in combination with an aortic tissue valve.
Previously available only with mechanical valves, Sorin Group's innovative Mitroflow Valsalva Conduit now offers cardiac surgeons a solution for replacing simultaneously the ascending aorta and the diseased aortic valve with Sorin's highly durable MitroflowTM pericardial aortic valve.
The Mitroflow Aortic Pericardial Heart Valve has consistently demonstrated excellent hemodynamic performance, ease of implant and proven durability. Introduced in Europe in 1982 and U.S. FDA cleared in 2007, the Mitroflow valve is supported by 21 years of published long-term durability and demonstrates outstanding performance in patients under 60 years of age.
In addition to limiting the bypass, cross-clamp and procedural time, and reducing potential risks for the patient, the Mitroflow Valsalva Conduit also replicates the native sinus thereby preserving the patient's physiological hemodynamics and obviating the need for lifelong anticoagulation treatment. The Mitroflow Valsalva Conduit graft is impregnated with absorbable bovine cross-linked gelatine, thus eliminating the need for preclotting.
"The Mitroflow Valsalva Conduit offers the surgeons a convenient way to connect the Mitroflow valve to a clinically proven aortic graft at point of use in the operating room, allowing a quick and effective assembly of the Mitroflow valve", said Wilson Szeto, M.D., Associate Professor of Cardiac Surgery, University of Pennsylvania Medical Center, Penn Presbytarian Medical Center.
"The Mitroflow Valsalva Conduit launch represents our continued commitment to innovation and enhances our tissue heart valve portfolio in the U.S.," said André-Michel Ballester, CEO, Sorin Group.