Edwards Lifesciences Corporation announced that its PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) has received FDA approval for the treatment of patients with degenerative mitral regurgitation (DMR). The PASCAL Precision system, with its independent grasping, atraumatic clasp and closure, and ability to elongate, enables safe and effective treatment for patients with DMR. Engineered with an intuitive catheter and handle, the system is designed for maneuverability and stability, enabling precise navigation and implant delivery. Data from the CLASP IID pivotal trial, the first randomized controlled trial to directly compare two contemporary TEER therapies, will be presented as a late-breaking clinical science session on Sept.
17 at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. The PASCAL Precision system is one of multiple transcatheter repair or replacement therapies in development by Edwards that are designed to address mitral and tricuspid valve disease, and the company's first such therapy approved for DMR in the US. Edwards is committed to transforming the treatment of mitral and tricuspid patients, supported by a robust body of clinical evidence.
The commercial opportunity related to this approval is factored into 2022 financial expectations. Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve is used in the treatment of mitral regurgitation. TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stitch.