CryoLife has received CE mark for the On-X Ascending Aortic Prosthesis (AAP), allowing resumed distribution in the European Union.
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. CryoLife, a cardiac and vascular surgery company focused on aortic disease, says that associated aortic root diseases coexist in as many as 10% of all aortic valve replacements.
The On-X AAP has been absent from the market since late 2016. The company has said that it offers the best haemodynamics of any commercially available valved conduit device, and that it will resume selling the On-X AAP in the EU immediately.
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. According to CryoLife, the On-X Aortic Valve was the first mechanical aortic heart valve to receive both 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 enrollment 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.