Dive Brief:

• Edwards Lifesciences has won Food and Drug Administration approval for its Pascal Precision system for tricuspid valve repair, the company said Wednesday.
• Pascal’s expanded label covers use in patients with symptomatic severe tricuspid regurgitation. Edwards previously received FDA approval for the device in degenerative mitral regurgitation.
• The approval should expand the group of tricuspid repair patients that Edwards can treat, Leerink Partners said in a note to investors.

Dive Insight:

The approval covers patients who have symptomatic severe tricuspid regurgitation, despite optimal medical therapy, and are at intermediate or greater risk for surgery. To use Pascal in that setting, a multidisciplinary heart team must deem the patient appropriate for transcatheter edge-to-edge tricuspid valve repair.

Securing an expanded label should “strengthen the company’s position in the large and underpenetrated transcatheter tricuspid market,” Leerink analysts said. Edwards already sells Evoque for transcatheter tricuspid valve replacement. Offering repair and replacement devices will allow clinicians “to select the most appropriate therapy for patients between Pascal and Evoque,” the analysts added.

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 company’s mitral valve portfolio is more comprehensive, with MitraClip used to repair valves and Tendyne implanted to replace them. 

Edwards shared details of the approval alongside the news that the FDA has authorized the Pascal Ace with Capture Clarity system for use in degenerative mitral TEER procedures. Pascal Ace is the first FDA-approved TEER device to include fluoroscopic indicators that confirm when valve leaflets have been grasped, Edwards 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 Christ Hospital Health Network’s Santiago Garcia said in a statement. “This simplifies placement of the device and increases confidence in our ability to achieve a successful M-TEER outcome.”