Sorin Group has announced the US commercial launch of the Mitroflow Valsalva Conduit. According to a company release, this is the only conduit graft approved by the US Food and Drug Administration (FDA) for use in combination with an aortic tissue valve.
Previously available only with mechanical valves, the Mitroflow Valsalva Conduit can now be used to replace simultaneously the ascending aorta and the diseased aortic valve with the Mitroflow pericardial aortic valve (Sorin Group).
The Mitroflow Aortic Pericardial Heart Valve has consistently demonstrated excellent haemodynamic performance, ease of implant and proven durability. Introduced in Europe in 1982 and US 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.1, 2
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 haemodynamics 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, associate professor of Cardiac Surgery, University of Pennsylvania Medical Center, Penn Presbytarian Medical Center, USA.
1. Yankah, et al. Aortic valve replacement with the Mitroflow pericardial bioprosthesis: Durability results up to 21 years. J Thorac Cardiovasc Surg. 2008; 136:688-696.
2. Yankah, C. Mitroflow pericardial aortic bioprosthesis in patients younger than 60 years. J Thorac Cardiovasc Surg. 2010; 140: e83-4.6.