The agency’s green light in severe tricuspid regurgitation adds the clip-based Pascal Precision system alongside Edwards’ Evoque implant for replacing the valve entirely.
According to the company, the latest approval now makes it the only manufacturer to offer transcatheter edge-to-edge repair and replacement therapies in the U.S. for both the mitral and tricuspid valves. Pascal Precision picked up its mitral regurgitation approval in 2022, while the Sapien M3 was approved for replacing that valve late last year.
“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 VP for transcatheter mitral and tricuspid therapies.
Delivered through the femoral artery, the nitinol implant can independently grasp the leaflets of the tricuspid valve separating the right atrium and ventricle, and can be repositioned before final closure. At that point it holds the leaflets together to help the valve form a tighter seal.
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“With the addition of the PASCAL tricuspid valve repair system to our portfolio of tricuspid transcatheter therapies, Edwards is able to support the treatment of a broader group of tricuspid patients, empowering clinicians to select the most appropriate therapy to treat more patients and support optimal clinical results,” Chopra added.
In addition, Edwards announced that it collected a new approval from the FDA for its Pascal Ace clip implant, adding the company’s Capture Clarity system that provides fluoroscopic indicators when valve leaflets have been grasped in mitral repair procedures.
The company said it plans to present clinical data from Pascal Precision’s pivotal trial in tricuspid repair at the Cardiovascular Research Foundation’s annual Transcatheter Cardiovascular Therapeutics conference, being held October 31 to November 3 in San Diego.
