Edwards Lifesciences has received CE marking for its transfemoral transcatheter mitral valve replacement system, setting up market rivalry with Abbott.
Edwards’ device, dubbed Sapien M3, is the first approved system to use a transfemoral approach to treating mitral regurgitation. Edwards’ system consists of a dock made of nitinol, while the valve itself is made of cow tissue attached to a cobalt-chromium frame.
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Shares in the New York-listed company were up 1.8% at market open following the announcement on 14 April, compared with the prior day’s opening price. Edwards has a market capitalisation of $40.6bn.
Mitral regurgitation is the most common type of heart valve disease. It occurs due to dysfunction in the mitral valve, causing blood to leak back into the left atrium. Mitral valve replacement is a procedure that replaces a patient’s damaged valve with a new valve, either made from biological or mechanical structures. The device can either be implanted by open-heart surgery or through a minimally invasive approach.
Before the approval for Edwards’ Sapien M3, Abbott was the only company on the European market, courtesy of its Tendyne device. Tendyne received CE marking in 2020 to treat patients with severe mitral regurgitation who are ineligible for open-heart surgery.
A market model by GlobalData unsurprisingly shows Abbott as having a 100% share of the global market. The transcatheter mitral valve implant market is forecast to be worth more than $250m by 2034, owing to an increasing prevalence of heart disease. The broader mitral valve replacement market is projected to reach $16.3bn by the same year.
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By GlobalDataEdwards entry into the European market sets up an acute competition with Abbott due to the different routes of implantation. Unlike Sapien M3’s transfemoral approach, Abbott’s Tendyne is implanted via an insertion into the apex of the left ventricle.
Other devices such as Abott’s MitraClip use a transfemoral approach, but these repair the existing valve, rather than replacing it with a new one. The markets for transcatheter mitral valve implantation devices and transcatheter mitral valve repair devices are distinct.
Edwards states that data shows the Sapien M3 system substantially reduces mitral regurgitation and improves quality of life. The company expects to present results from the ENCIRCLE pivotal trial, evaluating its system in patients, in late 2025.
Edwards has made no secret of its intention to expand market share in the heart valve replacement sector. The company bought transcatheter mitral valve replacement specialist Innovalve Bio Medical in 2024 for around $300m. In further cardiovascular market boosts, Edwards then outlaid a further $1.2bn to acquire two other cardiac device companies last year.
Daveen Chopra, Edwards’ corporate vice-president for transcatheter mitral and tricuspid therapies, said: “We were the first to gain CE Mark for a transcatheter tricuspid valve replacement system, and with the Sapien M3 system’s approval, Edwards is now the only company providing a transcatheter portfolio that includes both replacement and repair treatment options for both the mitral and tricuspid valves.”
