Edwards wins U.S. approval for tricuspid valve repair after segment sales rise 47.3%
Key Facts
Edwards Lifesciences said in a statement dated October 21 that its PASCAL Precision system had received U.S. Food and Drug Administration approval for transcatheter tricuspid valve repair. The approved indication aims to improve quality of life and functional status in patients with severe symptomatic regurgitation. The eligible population includes those whose symptoms persist despite optimal medical therapy, according to the company's statement. The approval requires patients to be at intermediate or greater surgical risk, with a multidisciplinary heart team assessing their suitability for transcatheter repair. The approval adds a repair option to Edwards' portfolio, which also includes the EVOQUE system for transcatheter replacement of the native tricuspid valve.
The move follows growth in the company's transcatheter mitral and tricuspid therapies segment sales to $195.9 million in the second quarter of 2026. The year-on-year increase was 47.3%, while constant-currency growth was 44.8%, according to Edwards' earnings statement. These figures represent adjusted segment sales, excluding the implantable heart failure management business. The company attributed the performance to its portfolio of transcatheter valve repair and replacement therapies. It raised its segment sales guidance range to $760–780 million from $740–780 million previously. Longer term, Edwards aims to generate $2 billion in segment sales by 2030, according to its stated investor strategy.
Tricuspid regurgitation occurs when the valve does not close fully, allowing blood to flow backward within the heart, according to Edwards' patient information. The PASCAL system treats the valve through a minimally invasive catheter procedure. The catheter is inserted through a vein in the groin and advanced to the treatment site. The device is then attached to the valve leaflets, according to the company's description of the procedure. The design uses clasps and paddles to grasp the leaflets, along with a spacer for the regurgitant opening. Edwards said in its description of the device's design that the spacer is "designed to fill the area of the regurgitant opening and prevent backward flow."
The CLASP II TR study compares the device's safety and effectiveness when added to optimal medical therapy with optimal medical therapy alone. On U.S. healthcare coverage, the Centers for Medicare & Medicaid Services issued a national coverage determination for transcatheter tricuspid valve repair on July 2, 2025. The determination covers FDA-approved devices under the Coverage with Evidence Development framework and subject to specific conditions. This framework ties coverage to participation in a CMS-approved study, according to the determination. It states that the procedure is "not covered for patients outside a CMS-approved study."
Edwards is entering a U.S. tricuspid valve repair market that includes Abbott's TriClip G4 device. Abbott's device has an FDA approval decision dated April 1, 2024, according to the agency's records. The PASCAL Precision system previously received U.S. approval for mitral valve repair on September 14, 2022. In Europe, Edwards announced that PASCAL had received the CE mark for treating tricuspid regurgitation on May 18, 2020. The company's recent approvals also include the AUTUS surgical pulmonary valve for children. Edwards says the valve can be expanded as a child grows, potentially reducing the need for repeat open-heart surgeries.
Edwards plans to hold an investor meeting in San Diego on Monday, November 2, alongside the Transcatheter Cardiovascular Therapeutics conference. The meeting includes a question-and-answer session with physicians and company management, according to its announcement. Edwards had listed the CLASP II TR study among the clinical presentations expected at the conference. This will be followed by its third-quarter earnings release, which the company has scheduled for Wednesday, November 4. The results are due after the market closes, according to Edwards' announcement of the financial reporting date.