FDA Approval of Edwards Lifesciences’ PASCAL Precision System Opens New Treatment Pathway for Patients With Tricuspid Valve Disease

IRVINE, Calif.--(BUSINESS WIRE)--Oct 21, 2026--

Edwards Lifesciences Corporation (NYSE: EW) today announced that the U.S. Food and Drug Administration (FDA) has approved its PASCAL Precision system for tricuspid valve repair. The system is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical therapy who are deemed at intermediate or greater risk for surgery and deemed appropriate for transcatheter edge-to-edge tricuspid valve repair (T-TEER) by a multidisciplinary heart team. With this approval, Edwards is now the only company to provide a portfolio of repair and replacement transcatheter therapies for the mitral and tricuspid valves in the United States.

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“The PASCAL system has been a valuable option for treating patients suffering with debilitating symptoms from degenerative mitral regurgitation in the US for several years, and we’re pleased that this differentiated therapy is now available to tricuspid patients in the US,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “With the addition of the PASCAL tricuspid valve repair system to our portfolio of tricuspid transcatheter therapies, Edwards is able to support the treatment of a broader group of tricuspid patients, empowering clinicians to select the most appropriate therapy to treat more patients and support optimal clinical results.”

“The differentiated features of the PASCAL system provide many benefits in navigating complex and challenging anatomies, and it is exciting to now have this therapy available for our tricuspid patients in the US,” said Santiago Garcia, MD, director of The Structural Heart Program, The Christ Hospital Health Network.

The company also shared that the FDA has approved the PASCAL Ace with Capture Clarity system for use in degenerative mitral TEER procedures (M-TEER). The PASCAL Ace with Capture Clarity system has become the first FDA-approved TEER device to include fluoroscopic indicators that provide confirmation when valve leaflets have been grasped, addressing a challenging step in TEER cases and simplifying procedural complexity.

“Building on the PASCAL system’s intuitive design, the Capture Clarity indicators provide a novel and easy way of confirming leaflet capture, which is critical and can be challenging. This simplifies placement of the device and increases confidence in our ability to achieve a successful M-TEER outcome,” continued Dr. Garcia.

One-year data from the CLASP IITR pivotal trial studying the PASCAL tricuspid system will be presented during late-breaking sessions at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

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, statements regarding expected product benefits, including the benefits of the novel features of the device, statements regarding increasing confidence for successful results, 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, Capture Clarity, CLASP, CLASP II, PASCAL, PASCAL Ace, and PASCAL Precision are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

Edwards Lifesciences' PASCAL Ace with Capture Clarity transcatheter mitral valve repair system

Edwards Lifesciences' PASCAL transcatheter tricuspid valve repair system

BELGRADE, Serbia (AP) — When Irina Djordjic registered in Canada to vote in an election this weekend in her native Serbia, she expected a repeat of the 2023 poll: a short drive to the consulate in Vancouver for a relaxed Sunday afternoon voting with fellow Serbs. She was wrong.

Djordjic, who holds dual Canadian-Serbian citizenship, was told that her polling station had moved to Toronto, 3,500 kilometers (2,175 miles) away, and would open at 2 a.m. to match polls opening in the Serbian time zone, where it's 8 a.m.

The decision by the Serbian election authorities meant that she and hundreds of other Serbs in Vancouver would have to take a 4.5-hour flight and possibly line up in the middle of the night to vote. Thousands of Serb expatriates in the United States, Australia and New Zealand face the same problem. Some 100,000 people have registered to vote abroad this year, up from 39,000 in 2023.

Critics say it's a deliberate move to discourage voters abroad, who may be less supportive of populist strongman Aleksandar Vucic as he faces his biggest electoral challenge yet from a youth movement behind almost two years of protests against Vucic's tight rule in the Balkan country. Turnout in Serbia is expected to be high, which is believed to favor the students.

"Some people have small children, some can’t be absent for too long,” Djordjic, a former journalist from Belgrade who now works as a fundraiser in Canada, told The Associated Press in a phone interview.

Serbia’s student movement grew out of mass anti-corruption protests sparked by a canopy collapse that killed 16 people at a renovated railway station in northern Serbia on Nov. 1, 2024. They blamed the disaster on government graft during renovation work.

Vucic’s SNS party and the student movement are running close ahead of the vote and tens of thousands of ballots from abroad could make a difference.

Borko Stefanovic, an opposition politician who is a former senior Foreign Ministry official, told the AP that the “regime did everything to prevent our citizens abroad from voting, out of fear of losing power.” He noted that “diplomatic and consular missions must be in the service of every citizen.”

Government officials rejected criticism. Foreign Minister Marko Djuric has said on X that the changes were guided “not only by the number of registered voters, but also by logistical, security, spatial, (and) staffing” criteria.

Serbia’s election commission has rejected all complaints. Its final list includes 93 polling stations aboard, 12 more than in 2023. Nine of the additional 12, however, are in Bosnia, a neighboring country slightly smaller than West Virginia, where ethnic Serbs have mostly supported Vucic and his party. Many have dual Serbian citizenship and the right to vote in Serbian elections. Authorities in Serb-run half of Bosnia, who are allied with Serbia's populists, have banned any activities in support of the students.

Realizing the global scale of the issue, Serbs around the world decided to try a more universal solution. Enter VoteBnB, a nonprofit website that connects people willing to offer spare rooms, car-sharing, or organized transport.

The website has offered 1,300 accommodation offers and more than 750 ride-share offers that have been matched with hundreds of requests from Serbs eager to reach polling stations in Europe, North America and Australia.

In Canada, Serbs from Vancouver “reached out to our friends in Toronto and arranged airport transfers, accommodation with other volunteers, whatever was needed," Djordjic said. "And it worked.”

It's a “large network of volunteers, one big community,” Djordjic said.

This story corrects the spelling of name to Djordjic.

A billboard with an image of Aleksandar Vucic, former authoritarian president, is seen on a closed brewery in Belgrade, Serbia, Sunday, Oct. 18, 2026. (AP Photo/Darko Vojinovic)

Citizens have badges with the number "3", the ballot number of Students' List election ticket and stickers with the logo "Students are winning", on the main pedestrian street in downtown Belgrade, Serbia, on Oct. 14, 2026. (AP Photo/Darko Vojinovic)

A billboard with the image of Aleksandar Vucic, former authoritarian president, is seen on a closed brewery in Belgrade, Serbia, Sunday, Oct. 18, 2026. (AP Photo/Darko Vojinovic)