Edwards Lifesciences has claimed an FDA approval for its Sapien M3 transcatheter mitral valve replacement system—marking the agency’s first in this type of implant that takes a potentially safer route through the heart’s chambers and can allow for a swifter patient recovery.
The company described it as the first minimally invasive mitral regurgitation therapy to employ the transseptal approach, where a small hole is made through the inner wall separating the heart’s left and right atria, so the catheter can reach its target.
The Sapien M3’s green light covers patients with moderate to severe backflow through the mitral valve who are unsuitable for open heart surgery or a transcatheter edge-to-edge repair procedure. It will also carry indications for severe narrowing of the valve and other dysfunction associated with calcification around its circumference, which may prevent some patients from receiving other treatments.
The procedure includes two steps: the implantation of a docking ring, which twists around the valve’s tendon-like cords to create a landing zone with a tight seal, followed by the placement of the valve itself. Both are inserted through a puncture in the leg’s femoral vein before being advanced into the heart.
“Over our more than 65-year history, Edwards has continued to push the boundaries of structural heart innovation, and today, with the addition of mitral replacement to our portfolio of FDA-approved transcatheter therapies that already includes mitral repair, we are expanding the treatable patient population in the U.S.,” Daveen Chopra, corporate VP of transcatheter mitral and tricuspid therapies, said in a statement.
Earlier this year, the Sapien M3 picked up a CE Mark in Europe, making it the continent’s first transfemoral mitral valve replacement implant. Edwards previously acquired the two-piece implant technology through its $300 million purchase of Innovalve in July 2024.
In October at the Transcatheter Cardiovascular Therapeutics conference in San Francisco, Edwards presented results from a single-arm pivotal trial of nearly 300 patients who were unsuitable for other therapies.
The year-long, international study met its primary and secondary endpoints, with about 95% of participants seeing an almost complete elimination of their mitral regurgitation, as well as no procedural complications. The results were simultaneously published in The Lancet.
In May, the FDA issued an approval to Abbott’s Tendyne mitral valve replacement, a sibling to the company’s MitraClip repair implant. Tendyne is also aimed at reaching more patients with calcifications or comorbidities that would make them ineligible for other procedures, with a dual-frame design that includes an outer ring and an inner bioprosthetic.
Instead of the transseptal approach, Tendyne takes the apical route and enters via the heart's ventricle through the lower tip of the cardiac muscle. The implant comes tethered to an anchoring pad that also seals off the entry point. Tendyne previously received European approval in January 2020.
Meanwhile, companies like 4C Medical have been advancing mitral implants such as its globe-shaped AltaValve, which fits entirely in the left atrium. The outfit posted a $175 million venture capital round in March, led by Boston Scientific.