FDA approves Edwards Lifesciences' PASCAL Precision system for tricuspid valve repair
Oct 22, 2026
Edwards Lifesciences (NYSE: EW) announced on Wednesday, October 21, 2026 that the US Food and Drug Administration (FDA) has approved its PASCAL Precision system for transcatheter repair of the tricuspid valve.
What was approved
According to the company, the FDA approved:
- the PASCAL Precision system for transcatheter edge-to-edge repair of the tricuspid valve (T-TEER), for patients with symptomatic severe tricuspid regurgitation who remain symptomatic despite optimal medical therapy, are at intermediate or greater surgical risk and are considered suitable for the procedure by a heart team
- the PASCAL Ace implant with Capture Clarity for edge-to-edge repair of the mitral valve in patients with degenerative mitral regurgitation
Edwards said the Capture Clarity design is the first FDA-approved TEER device with indicators visible on X-ray imaging that confirm when the valve leaflets have been grasped. The company said the tricuspid therapy is now available to patients in the United States.
What tricuspid regurgitation is
The heart has four valves that keep blood flowing in one direction. The tricuspid valve sits between the two chambers on the right side of the heart. In tricuspid regurgitation, the valve does not close properly and blood leaks backwards. Severe cases can cause symptoms such as tiredness, shortness of breath and swelling in the legs and abdomen.
How the procedure works
Transcatheter edge-to-edge repair is carried out through a thin tube, called a catheter, that is usually inserted through a vein in the leg and guided to the heart. The device clips the edges of the valve leaflets together to reduce leakage. Because it does not require open-heart surgery, this type of procedure may be an option for patients who face higher risks from surgery.
Trial data
The approval for the tricuspid valve is supported by the CLASP IITR pivotal trial. Edwards said one-year data from the trial will be presented at a late-breaking session at TCT, an annual cardiology conference organised by the Cardiovascular Research Foundation.
What Edwards said
Daveen Chopra, corporate vice president for transcatheter mitral and tricuspid therapies at Edwards, said PASCAL is "a valuable option for treating patients suffering with debilitating symptoms". Edwards said it is now the only company in the US offering a portfolio of both repair and replacement transcatheter therapies for the mitral and tricuspid valves.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, California, develops medical devices for structural heart disease and critical care. It is known for its transcatheter aortic valve replacement (TAVR) products, which replace the aortic valve without open-heart surgery. In recent years, the company has expanded into therapies for the mitral and tricuspid valves, which it describes as a growing part of its business.
Why approvals matter for medical device companies
For medical device makers, regulatory approval allows a product to be sold in a market and can open up new groups of patients. The commercial impact usually depends on factors such as how quickly doctors adopt the procedure, training, reimbursement by insurers and competition from other devices.
What to watch
Key items include the full CLASP IITR data at TCT, the pace of adoption of the tricuspid therapy in US hospitals and any comments on the new products in Edwards' upcoming quarterly results.
Risks and uncertainties
Medical devices carry risks for patients, and longer-term data may differ from early results. Uptake of new therapies can be slower than expected, and competition in structural heart devices is significant. Medical technology shares can be volatile.
What this means for investors
For Investing.one users following EW, the new approvals and their adoption may be relevant. The information above is based on the company's announcement.
Sources
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