CryoLife Inc (NYSE: CRY), a cardiac and vascular surgery company focused on aortic disease, announced on Thursday that it has received the CE Mark for the On-X Ascending Aortic Prosthesis, allowing resumed distribution in the European Union.
The On-X Ascending Aortic Prosthesis is indicated for the treatment of diseased, damaged or malfunctioning native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm.
Pat Mackin, chairman, president, and chief executive officer of CryoLife, said, 'The absence of the On-X AAP from the market since late 2016 has hindered our ability to compete for certain mechanical valve tenders in the EU. With the receipt of the CE Mark on the AAP, we once again have a complete portfolio of On-X products available in Europe, allowing us to be more competitive and potentially drive market share gains in the mechanical valve market. The On-X AAP offers the best hemodynamics of any commercially available valved conduit device, and we will resume selling the On-X AAP in the EU immediately.'
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