CryoLife Inc. (NYSE:CRY) announced that it received CE Mark approval for the On-X ascending aortic prosthesis (AAP) for treating native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm.
The approval allows for resumed distribution of the On-X AAP in Europe, as the product has been off the market there since late 2016, according to a news release. CryoLife entered the valve market with the purchase of On-X Life Technologies in January 2016, but dealt with legal battles over a $10 million escrow account connected with the merger in 2017.
On-X AAP is part of On-X’s heart valve portfolio, which includes the On-X aortic valve and mitral valve. The On-X AAP is indicated for treating diseased, damaged or malfunctioning native or prosthetic heart valves. According to a news release, the associated aortic diseases it’s designed to treat coexist in as many as 10% of all aortic valve replacements
CryoLife chairman, president & CEO Pat Mackin said that the company plans to resume selling the On-X AAP in the European Union immediately.
“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,” Mackin said. “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. “