Transcatheter Repair System Gains FDA Approval for Severe Tricuspid Regurgitation

For these patients, a multidisciplinary heart team determines whether transcatheter edge-to-edge tricuspid valve repair is appropriate. Expanding treatment options in this setting, a new system has received U.S. Food and Drug Administration (FDA) approval for transcatheter repair.

Edwards Lifesciences’ PASCAL Precision system for tricuspid valve repair is indicated to improve quality of life and functional status in patients with symptomatic severe tricuspid regurgitation who remain symptomatic despite optimal medical therapy. The system is intended for patients at intermediate or greater surgical risk who are considered appropriate for transcatheter edge-to-edge tricuspid valve repair (T-TEER) by a multidisciplinary heart team. With the approval, Edwards Lifesciences becomes the only company in the United States with a portfolio of transcatheter repair and replacement therapies for both the mitral and tricuspid valves.

The PASCAL Precision tricuspid system uses a transcatheter edge-to-edge repair approach to treat tricuspid valve disease. Edwards Lifesciences also received FDA approval for the PASCAL Ace with Capture Clarity system for degenerative mitral transcatheter edge-to-edge repair (M-TEER). The system incorporates fluoroscopic indicators that confirm when valve leaflets have been grasped, helping simplify a technically challenging step of the procedure.

The PASCAL Ace with Capture Clarity system is the first FDA-approved TEER device to include fluoroscopic indicators for confirming leaflet capture. One-year data from the CLASP IITR pivotal trial evaluating the PASCAL tricuspid system are scheduled for presentation during late-breaking sessions at Transcatheter Cardiovascular Therapeutics.

“The differentiated features of the PASCAL system provide many benefits in navigating complex and challenging anatomies, and it is exciting to now have this therapy available for our tricuspid patients in the US,” said Santiago Garcia, MD, director of The Structural Heart Program, The Christ Hospital Health Network.

“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. This simplifies placement of the device and increases confidence in our ability to achieve a successful M‑TEER outcome,” added Dr. Garcia.