Sep 23 2009
On Sept. 22, SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, announced an exclusive technology licensing agreement with AorTech International plc (AIM: AOR). This agreement licenses the use of AorTech’s Elast-Eon™ polymer heart valve (PHV) in the Total Artificial Heart, as well as SynCardia’s future family of pulsatile products.
“The Total Artificial Heart is the only device that eliminates biventricular heart failure by replacing both failing ventricles,” said Michael Gaul, SynCardia Chief Operating Officer (photo). “The Elast-Eon PHV is designed to provide reliable support for patients who need the Total Artificial Heart as their Bridge To Life™.”
“Our polymer heart valve has been tested extensively and has satisfied FDA pre-requisites for human use,” said Frank Maguire, AorTech Chief Executive Officer. “The valve has been shown to have durability superior to that of biologic valves and comparable hemodynamic characteristics. In these studies, it has consistently demonstrated freedom from calcification and thrombus formation.”
Due to its outstanding operating efficiency, the Elast-Eon valve requires less pressure and therefore less power to open and close. It is anticipated that the valve’s efficiency will lengthen discharge driver battery life and result in quieter operation of the Total Artificial Heart, helping improve patient quality of life while they wait for a matching donor heart.
The license structure includes $2.1 million in fees payable over an 18 month period, minimum valve purchases and volume related discounts.
SynCardia anticipates animal studies later this year, with FDA and CE Mark submissions in 2H 2010.
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