FDA clears Edwards tricuspid valve repair device

Medical team conducting surgery in a sterile operating room with surgical tools on display. Photo: DΛVΞ GΛRCIΛ/Pexels

Edwards Lifesciences announced Wednesday that the FDA granted clearance for its Pascal Precision platform to treat tricuspid valve issues. The expanded indication applies to patients suffering from severe symptomatic tricuspid regurgitation, despite receiving optimal medical treatment, who face intermediate or higher surgical risk.

Analysts said the approval should strengthen the company’s position in the large and underpenetrated transcatheter tricuspid market.

To use Pascal in this setting, a multidisciplinary heart team must deem the patient appropriate for transcatheter edge-to-edge tricuspid valve repair. The expanded label allows clinicians to select the most appropriate therapy for patients between Pascal and Edwards’ Evoque, which is used for transcatheter tricuspid valve replacement.

Edwards primarily competes with Abbott for the transcatheter mitral and tricuspid therapy market. The new approval gives Edwards a broader portfolio, with the company claiming it is the only U.S. provider of repair and replacement transcatheter therapies for mitral and tricuspid valves. Abbott sells TriClip for tricuspid valve repair but lacks an FDA-approved medical device for transcatheter replacement of the tricuspid valve.

The FDA has also authorized the Pascal Ace with Capture Clarity system for use in degenerative mitral TEER procedures. Santiago Garcia of The Christ Hospital Health Network said, “Building on the Pascal system’s intuitive design, the Capture Clarity indicators provide a novel and easy way of confirming leaflet capture, which is critical and can be challenging.”

The Capture Clarity indicators simplify placement of the device and increase confidence in the ability to achieve a successful M-TEER outcome, Garcia said. They are fluoroscopic indicators that confirm when valve leaflets have been grasped, Edwards said.