Edwards Lifesciences Gains FDA Approval for PASCAL Tricuspid Repair and Mitral Capture Clarity

Edwards Lifesciences received FDA approval for its PASCAL Precision system for tricuspid valve repair, the company said on October 21, 2026. The approval covers patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy who are deemed at intermediate or greater risk for surgery. Edwards also said the FDA approved PASCAL Ace with Capture Clarity for degenerative mitral TEER procedures. The announcement was distributed by Business Wire.

What the PASCAL Precision Approval Covers

Edwards Lifesciences is a global medical device company that designs and sells transcatheter and surgical heart valve therapies, including the SAPIEN, PASCAL and EVOQUE platforms, to hospital systems and cardiac care centers treating structural heart disease. The PASCAL Precision system is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation who are deemed appropriate for transcatheter edge-to-edge tricuspid valve repair by a multidisciplinary heart team.

"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.

Santiago Garcia, MD, director of The Structural Heart Program at The Christ Hospital Health Network, said the PASCAL system's features help in navigating complex anatomies. Edwards said the PASCAL Ace with Capture Clarity system is the first FDA-approved TEER device to include fluoroscopic indicators that confirm when valve leaflets have been grasped.

Edwards Lifesciences' Structural Heart Portfolio

According to akta.pro company records, Edwards Lifesciences completed the sale of its Critical Care product group to Becton, Dickinson and Company for $4.2 billion in April 2026, refocusing the company on structural heart as its core growth platform. The same records show Edwards serves patients in numerous countries and that more than 500,000 patients have received its heart valve technologies worldwide. Edwards Lifesciences was founded in 1960 and is headquartered in Irvine, California.

Earlier FDA Actions and Investor Events

On October 15, 2026, Yahoo reported that the FDA warned of a high-risk issue with certain Edwards delivery systems for transcatheter mitral valve replacement after one death and one serious injury, and that Edwards asked customers to remove affected devices from use and return impacted products. On October 1, 2026, Stock Titan reported that Edwards received FDA approval for the AUTUS Size-Adjustable Valve, the first surgical pulmonary valve for pediatric patients with congenital heart disease. On October 5, 2026, Stock Titan reported that Edwards will host an investor event on November 2 in conjunction with the TCT scientific symposium in San Diego.

What Comes Next for Edwards

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, the annual scientific symposium of the Cardiovascular Research Foundation. Edwards will host an investor event on November 2 in San Diego with a live Q&A with physicians and management.