Two Year Data on Edwards Lifesciences’ EVOQUE System Continue to Demonstrate Significant and Sustained Patient Benefits

Key Terms

transcatheter tricuspid valve replacement medical

A transcatheter tricuspid valve replacement is a minimally invasive medical procedure that replaces the heart’s tricuspid valve using a device delivered on a thin tube (catheter) threaded through blood vessels, avoiding open‑chest surgery. For investors, it matters because successful devices and clinical results can expand treatment options, drive sales, reduce hospital stays and costs, and affect regulatory approvals and reimbursement decisions that influence company revenue and market growth.

ttvr medical

Transcatheter tricuspid valve replacement (TTVR) is a minimally invasive procedure that uses a thin tube threaded through a blood vessel to implant a replacement valve in the heart’s tricuspid valve, which controls blood flow between two right-side chambers. For investors, TTVR represents a potential commercial opportunity tied to an aging population and unmet medical need, but its market impact depends on clinical success, regulatory approval, procedural adoption, and reimbursement—similar to how a new, easier-to-use tool can open a big niche if it works reliably and pays off financially.

tricuspid regurgitation medical

Tricuspid regurgitation is a condition where the tricuspid valve in the heart does not close properly, allowing blood to leak backward from the pumping chamber into the receiving chamber. Think of it like a door that won’t seal, so flow moves the wrong way. Investors care because its severity drives demand for medical treatments, devices and diagnostics, affects healthcare costs and reimbursement, and can influence clinical trial outcomes and company revenue in the cardiovascular sector.

all-cause mortality medical

All-cause mortality is the total number of deaths from any cause within a defined group over a specific time period. For investors, it is a broad safety and outcome measure used in clinical trials and public-health studies—like counting everyone who leaves a club for any reason—because higher or lower all-cause mortality can influence regulatory decisions, product reputation, long-term liability and market value.

sts/acc tvt registry medical

A national clinical database run jointly by leading professional societies that collects standardized, real‑world data on transcatheter heart valve procedures (who gets treated, outcomes, and complications) from hospitals across the country. Think of it as a national scoreboard and safety log for these minimally invasive valve treatments; its findings influence regulators, hospitals and insurers, shape adoption of devices, and therefore affect regulatory approval, reimbursement decisions and the commercial prospects investors care about.

TRISCEND II randomized trial data presented at ACC show lower mortality with EVOQUE system, when accounting for patient crossover

NEW ORLEANS--(BUSINESS WIRE)-- Edwards Lifesciences (NYSE: EW) today announced new data on the EVOQUE transcatheter tricuspid valve replacement (TTVR) system at the American College of Cardiology Annual Scientific Session (ACC.26), demonstrating significant and sustained patient benefits including lower mortality when accounting for patient crossover, extending the findings presented at the European Society of Cardiology Congress (ESC 2025).

The new TRISCEND II trial data presented today during a late-breaking featured research session at ACC.26 demonstrated confidence in two-year performance of TTVR with the EVOQUE system and showed:

• Significant and sustained near elimination of tricuspid regurgitation (TR);
• Improvements in health status and quality of life;
• No added device-related risk; and
• Significantly lower all-cause mortality when accounting for patient crossover.

“There is a significant patient population suffering with debilitating symptoms from tricuspid regurgitation with very limited treatment options. It’s not a surprise that the sickest patients enrolled in the medical therapy control group of the randomized TRISCEND II trial opted to receive treatment with the EVOQUE system following the one-year primary endpoint, underscoring both the benefits of and need for TTVR therapy,” said Vinod Thourani, MD, FACS, FACC, Bernie Marcus Chairman, Department of Cardiovascular Surgery and Marcus Valve Center, Piedmont Heart Institute. “Our analyses, including the many highly symptomatic crossover patients, showed significantly improved outcomes for all of the EVOQUE treated patients.”

The 18-month data of the TRISCEND II trial were presented at ESC in August 2025, showing achievement of a hard endpoint benefit for the most severe TR patients who received the EVOQUE therapy, and superior quality of life benefits, regardless of baseline TR.

“Edwards remains focused on developing innovative solutions that meet the most pressing needs of patients with structural heart disease, and we’re proud of the life-changing benefits demonstrated with the EVOQUE system,” said Daveen Chopra, Edwards’ corporate vice president, transcatheter mitral and tricuspid therapies. “In addition to TRISCEND I and II data, the growing body of evidence on EVOQUE includes data on more than 1,000 patients in the STS/ACC TVT Registry presented at TCT last year, demonstrating consistent near elimination of tricuspid regurgitation, improved quality of life, and a positive real-world safety profile across the broad tricuspid patient population.”

The EVOQUE system is approved in both the US and Europe.

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 life-changing, significant and sustained benefits of the product, including superior quality of life, near elimination of tricuspid regurgitation, improved quality of life, and a positive real-world safety profile; 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, EVOQUE, TRISCEND, and TRISCEND II are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

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Media Contact: Loree Bowen, 714-403-2475

Investor Contact: Gerianne Sarte, 949-250-2528

Source: Edwards Lifesciences Corporation