Cardiac and vascular surgery company CryoLife has secured CE Mark for its On-X Ascending Aortic Prosthesis (AAP), enabling resumed distribution of the device in the EU.
On-X AAP is intended to treat damaged (or rectify the malfunctioning of) native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm. Aortic root diseases co-exist in almost as much as 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.”
The device is a part of CryoLife’s On-X Heart Valve portfolio that consists of On-X Aortic Valve and ON-X Mitral Valve among other prosthetic heart valves.
On-X Aortic Valve by CryoLife is claimed to be the first mechanical aortic heart valve to secure both FDA and CE Mark approval for its use with a reduced warfarin dosage based on PROACT trial results.
Trial results indicated over 60% reduction in bleeding events without complete risk of stroke.
Enrolment for On-X Mitral Valve’s PROACT (Lowered INR Mitral Arm) prospective randomised clinical trial is currently being performed.
The study is seeking a reduced warfarin indication similar to that of the On-X Aortic Valve.
Headquartered in Georgia, CryoLife manufactures and distributes medical devices, as well as implantable tissues for cardiac and vascular surgical procedures that focus on aortic repair.