U.S. Launch Of Sorin’s New Aortic Tissue Valve/Ascending Aorta Graft Combo

In short

Despite recent setbacks such as the odd earthquake, Italian cardiovascular device company Sorin Group has come back fighting and is trumpeting the U.S. commercial launch of the Mitroflow Valsalva Conduit™. This device is the only Valsalva conduit graft approved by the U.S. FDA for use in combination with an aortic tissue valve.

Background

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 Mitroflow™ 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 of preclotting.

Physician comments

“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 Presbyterian Medical Center.

Company comments

“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.

Source: Sorin Group