US-based Edwards Lifesciences has received CE Mark approval in Europe to market its next-generation Sapien XT transcatheter heart valve system for either mitral or aortic valve-in-valve procedures.
It provides a minimally invasive treatment option for patients who need to replace their surgical mitral or aortic valves and face risks from conventional surgery.
Edwards is claimed to be the only device maker with EU approval for transcatheter valve-in-valve implantation of the mitral valve.
Edwards transcatheter heart valves corporate vice-president Larry L Wood said: "While this is not a large financial opportunity, it represents an important benefit for patients unable to go through a second open-heart surgery to replace their failing bioprosthetic valves."
According to the company, more than 300,000 heart valve operations are performed worldwide annually through open-heart surgery, using either bioprosthetic tissue valves or mechanical valves.
Demand for Edwards' Perimount bovine pericardial tissue heart valves continues to increase due to bovine pericardial valves' durability and enhanced quality-of-life advantages over mechanical valves, which can cause blood clotting and require life-long blood-thinning medication that imposes lifestyle restrictions and long-term bleeding risks.
Decades of clinical experience and peer-reviewed data on Edwards' valves provide robust evidence of long-term performance and optimal haemodynamics of the Perimount valve platform.
King's College Hospital in London professor of cardiac surgery and one of the principal investigators of the SOURCE XT Registry Dr Olaf Wendler said just as native heart valves experience wear over time, bioprosthetic valves eventually degenerate too, creating a need for a replacement valve.
"The European adoption of valve-in-valve procedures using Sapien XT is an important development for treating patients who may otherwise go untreated," Dr Wendler said.
"In particular, patients needing a re-operation to address a failing mitral valve face a very challenging surgery, and the ability to offer a transcatheter replacement is extremely important for this patient group."
Dr Wendler provides paid consulting services to Edwards for education, and research and development of transcatheter valve technologies.
In the US, the Sapien XT valve is not commercially available; it is an investigational device being studied as part of the randomised, pivotal PARTNER II Trial.
According to GlobalData estimates, the Europeean transcatheter heart valves market was valued at $648m in 2012 and is expected to grow at a CAGR of 18.5% to reach $2.12bn by 2019.
Image: Edwards' Sapien transcatheter heart valve Model 9000TFX and accessories. Photo: courtesy of US Food and Drug Administration.