CryoLife has announced it has received CE mark for the On-X Ascending Aortic Prosthesis (AAP), allowing resumed distribution in the European Union (EU). The On-X AAP is indicated for the treatment of diseased, damaged or malfunctioning native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm. These associated aortic root diseases coexist in as many as 10% of all aortic valve replacements.
“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 haemodynamics of any commercially available valved conduit device, and we will resume selling the On-X AAP in the EU immediately,” said Pat Mackin, chairman, president, and chief executive officer of CryoLife.
The On-X AAP is part of the On-X Heart Valve portfolio, which also includes the On-X Aortic Valve and On-X Mitral Valve. The On-X Aortic Valve was the first mechanical aortic heart valve to receive both US Food and Drug Administration (FDA) and CE mark approval for labelling to permit use with a reduced warfarin dosage, based on results of the original PROACT trial that demonstrated a greater than 60% reduction in bleeding events without increased risk of stroke. The On-X Mitral Valve is currently completing enrolment in its own PROACT (Lowered INR Mitral Arm) prospective randomised clinical trial, seeking a reduced warfarin indication similar to that of the On-X Aortic Valve.