FDA Approves Edwards Lifesciences' SAPIEN M3 Mitral Valve Replacement System as First Transseptal Transcatheter Therapy

IRVINE, Calif.--(BUSINESS WIRE)--Dec 23, 2025--

Edwards Lifesciences (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach to receive U.S. Food and Drug Administration (FDA) approval for the treatment of mitral regurgitation (MR). The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is indicated for the treatment of symptomatic moderate-to-severe or severe MR in patients who are deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy by a multidisciplinary heart team. It is also indicated for the treatment of symptomatic mitral valve dysfunction (moderate-to-severe or severe MR, severe mitral stenosis (MS), or moderate MR with moderate MS) associated with mitral annular calcification (MAC) in patients who are deemed unsuitable for surgery or TEER therapy by a multidisciplinary heart team.

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“Mitral regurgitation is very common among valvular heart diseases, and these patients often present with debilitating symptoms that are life-threatening and significantly diminish their quality-of-life. Up to this point, many patients were unsuitable for available treatment options, leaving the vast majority untreated and suffering,” said David Daniels, M.D., Sutter West Bay Medical Group cardiologist and structural heart section chief of Sutter’s Heart & Vascular Service Line. “The SAPIEN M3 system’s ability to provide a fully percutaneous mitral valve replacement that safely delivers near elimination of significant mitral regurgitation and meaningfully improves their symptoms is a game-changer for these patients.”

The SAPIEN M3 TMVR procedure involves two steps: dock delivery followed by valve delivery, completely replacing the mitral valve. Both the dock and the valve are delivered through a percutaneous, 29F outer diameter steerable guide sheath inserted through the femoral vein.

One-year data from the ENCIRCLE single-arm pivotal trial was presented at TCT on October 27, 2025, and was simultaneously published in The Lancet. The trial achieved all primary and secondary endpoints for safety and effectiveness in the trial’s main cohort (299 patients unsuitable for other treatment options), achieving significant MR elimination (95.7% MR ≤ 0/1+) and meaningful improvements in symptoms and quality-of-life.

"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 US,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “Edwards is once again transforming care for patients with the SAPIEN M3 system, which is built on the foundation of the proven SAPIEN platform and is supported by positive one-year ENCIRCLE pivotal trial data . ”

The SAPIEN M3 system received CE Mark in April 2025, making it the world’s first approved transfemoral transcatheter mitral valve replacement system. Edwards’ portfolio of FDA-approved transcatheter mitral and tricuspid therapies includes the PASCAL Precision mitral valve repair system and the EVOQUE tricuspid valve replacement system.

About Edwards Lifesciences

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube.

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements made by Mr. Chopra and statements regarding expected product benefits, including near elimination of significant mitral regurgitation, improvement of symptoms, transforming care for patients and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, ENCIRCLE, EVOQUE, PASCAL, PASCAL Precision, SAPIEN, and SAPIEN M3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Edwards Lifesciences' SAPIEN M3 Transcatheter Mitral Valve Replacement System

JERUSALEM (AP) — Israeli settlers attacked a Palestinian home in the south of the Israeli-occupied West Bank overnight, breaking in and killing sheep, a Palestinian official said Tuesday. It was the latest in a surge of attacks by settlers against Palestinians in the territory in recent months.

Israeli police said they arrested five settlers.

The settlers killed three sheep and injured four more, smashed a door and a window of the home, and fired tear gas inside, sending three Palestinian children under the age of 4 to the hospital, said Amir Dawood, who directs an office documenting such attacks within a Palestinian governmental body called the Wall and Settlement Resistance Commission.

Police said they arrested the five settlers on suspicion of trespassing onto Palestinian land, damaging property and dispensing pepper spray, not tear gas. They said they are investigating.

CCTV video from the attack in the town of As Samu’, shared by the commission, showed five masked settlers in dark clothing, some with batons, approaching the home and appearing to enter. Sounds of smashing are heard, as well as animal noises. Another video from inside shows masked figures appearing to strike sheep in the stable.

Photos of the aftermath, also shared by the commission, show smashed car windows and a shattered front door. Bloodied sheep lie dead as others stand with blood staining their wool. Inside the home, photos show broken glass and the furniture ransacked.

Dawood said it was the second settler attack on the family in less than two months. He called it “part of a systematic and ongoing pattern of settler violence targeting Palestinian civilians, their property and their means of livelihood, carried out with impunity under the protection of the Israeli occupation.”

During October’s olive harvest, settlers across the territory launched an average of eight attacks daily, the most since the United Nations humanitarian office began collecting data in 2006. The attacks continued in November, with the U.N. recording at least 136 by Nov. 24.

Israel captured the West Bank, east Jerusalem and Gaza — areas claimed by the Palestinians for a future state — in the 1967 war. It has settled over 500,000 Jews in the West Bank, in addition to over 200,000 in contested east Jerusalem.

Israel’s government is dominated by far-right proponents of the settler movement, including Finance Minister Bezalel Smotrich and Cabinet Minister Itamar Ben-Gvir, who oversees the nation’s police force. Earlier this week, Smotrich said the Israeli cabinet had approved a proposal for 19 new Jewish settlements, another blow to the possibility of a Palestinian state.

A Palestinian boy shows one of the sheep that was injured during an Israeli settlers attack in the town of As Samu', near the West Bank city of Hebron, Tuesday, Dec. 23, 2025. (AP Photo/Mahmoud Illean)

Wafaa Rabie, 30, shows the door of her house that was damaged during an Israeli settlers attack in the town of As Samu', near the West Bank city of Hebron, Tuesday, Dec. 23, 2025. (AP Photo/Mahmoud Illean)

Young Palestinians walk next sheeps that were killed during an Israeli settlers attack in the town of As Samu', near the West Bank city of Hebron, Tuesday, Dec. 23, 2025. (AP Photo/Mahmoud Illean)

An Israeli settlers outpost is seen on area next to the town of As Samu', near the West Bank city of Hebron, Tuesday, Dec. 23, 2025. (AP Photo/Mahmoud Illean)

A Palestinian boy shows one of the sheep that was injured during an Israeli settlers attack in the town of As Samu', near the West Bank city of Hebron, Tuesday, Dec. 23, 2025. (AP Photo/Mahmoud Illean)

Young Palestinians show some of the sheeps that were killed during an Israeli settlers attack in the town of As Samu', near the West Bank city of Hebron, Tuesday, Dec. 23, 2025. (AP Photo/Mahmoud Illean)