Tricuspid Valve Replacement: Why Edwards Is Expanding Back Into Surgery

For years, the conversation around structural heart innovation has centered on less invasive procedures. That is what makes Edwards Lifesciences’ latest FDA approval noteworthy. While the company helped drive the shift toward catheter-based therapies, it has now introduced a new surgical option through the approval of the Triformis Resilia valve, the first device specifically designed for tricuspid valve replacement in the surgical setting.

The approval applies to a relatively limited patient population, but the broader significance extends beyond the label itself. It highlights how the treatment landscape for tricuspid disease is maturing and how Edwards is positioning itself to participate across the entire continuum of care.

The Numbers Behind the Opportunity

Tricuspid regurgitation (TR) affects an estimated 3.7% of adults over age 65. By comparison, aortic stenosis, the condition that helped build Edwards’ multibillion-dollar aortic valve franchise, impacts roughly 2% to 3% of that same population.

Despite the prevalence of TR, intervention rates remain remarkably low. More than 1.6 million adults are estimated to have moderate-to-severe TR, yet only about 40,000 patients, or roughly 2.5%, undergo tricuspid valve repair or replacement.

Historically, physicians have been hesitant to treat the condition surgically. Isolated tricuspid procedures carried significant risk, and outcomes were often uncertain. As a result, many patients were managed medically rather than referred for intervention.

Procedure volumes illustrate the gap. Data from the STS Adult Cardiac Surgery Database show that just over 2,000 isolated tricuspid operations are performed annually in the U.S. At most hospitals, that translates to only a handful of cases each year.

For a disease affecting more than 1.6 million patients, those numbers emphasize how underserved the market has been.

Recent advances in transcatheter therapies have begun to change referral patterns. Since FDA approval of Edwards’ Evoque transcatheter tricuspid valve replacement system, and Abbott’s TriClip became available for transcatheter repair, structural heart programs have reported growing patient interest and increasing evaluation volumes.

A trend familiar from the early days of TAVR is beginning to emerge. Some patients referred for catheter-based procedures are ultimately found to be better candidates for surgery.

Where Surgical Tricuspid Valve Replacement Fits

The Triformis Resilia valve is not intended to compete directly with Evoque or other transcatheter therapies. Instead, it addresses patient groups that current catheter-based technologies do not serve as effectively.

Those groups include patients with very large tricuspid annuli that exceed the sizing capabilities of today’s transcatheter devices, individuals already undergoing open-heart surgery for left-sided disease, and younger patients for whom surgical durability may be particularly important.

The concomitant surgery population is especially significant. Nearly half of tricuspid procedures performed in the U.S. occur alongside mitral valve surgery. In these cases, the chest is already open, making the addition of a tricuspid intervention a relatively modest extension of the procedure.

Before Triformis became available, surgeons often adapted valves originally designed for the aortic or mitral position. Edwards now offers a product purpose-built for the unique anatomy of the tricuspid valve while incorporating its Resilia tissue technology, which has demonstrated strong long-term durability in the surgical aortic setting.

A Portfolio Strategy Rather Than a Product Strategy

The approval is unlikely to materially alter the growth trajectory of Edwards’ transcatheter mitral and tricuspid businesses. The company expects those franchises to generate more than $780 million in 2026 revenue and grow 35% to 45% annually on the path toward a projected $2 billion opportunity by 2030.

What Triformis adds is strategic coverage.

Edwards already offers Evoque for transcatheter replacement and is awaiting FDA review of Pascal for transcatheter tricuspid repair. Once Pascal is approved, the company will have products spanning every major interventional approach for tricuspid disease.

The model resembles the strategy Edwards successfully executed in the aortic market. There, the SAPIEN platform serves transcatheter patients while the Resilia surgical portfolio addresses those who are not candidates for catheter-based treatment. That franchise now generates more than $1.3 billion in quarterly revenue.

The tricuspid market remains much smaller, but the underlying philosophy is similar. By offering solutions across surgical replacement, transcatheter replacement, and repair, Edwards can keep patients within its ecosystem rather than losing referrals when anatomy or clinical circumstances make a different treatment approach necessary.

The tricuspid valve was once known as the “forgotten valve” because treatment options were limited and intervention rates remained low. With Triformis, Evoque, and the anticipated addition of Pascal, Edwards is building a portfolio designed to address nearly every major tricuspid valve replacement and repair pathway. If referral patterns continue to develop as they did in the aortic market, the company’s long-term revenue targets may prove more achievable than they initially appear.