The approval enables resumed distribution of the device in the European Union
US-based cardiac and vascular surgery company CryoLife has secured CE Mark for the On-X Ascending Aortic Prosthesis (AAP).
The approval enables resumed distribution of the device in the European Union. It 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 stated that these associated aortic root diseases coexist in 10% of all aortic valve replacements.
CryoLife chairman, president, and CEO Pat Mackin 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.”
CryoLife’s On-X portfolio includes three products
The On-X Heart Valve portfolio comprises the On-X AAP, the On-X Aortic valve and ON-X Mitral valve.
The company claims that 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.
The approval was based on results of the original PROACT trial, which showed a greater than 60% reduction in bleeding events without increased risk of stroke.
Currently, the On-X Mitral Valve is completing enrollment in its own PROACT trial, which seeks a reduced warfarin indication similar to that of the On-X Aortic Valve.
Based in suburban Atlanta, Georgia, CryoLife manufactures, processes, and distributes medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair.
The company markets and sells products in over 100 countries across the globe.