Edwards Lifesciences’ Pascal Precision System Gains FDA Approval
Edwards Lifesciences’ Pascal Precision transcatheter valve repair system has received FDA approval for the treatment of patients with degenerative mitral regurgitation, a condition that leads to degeneration of the heart valves.
The system — which includes an intuitive catheter and handle plus independent grasping and atraumatic clasp and closure — is used for transcatheter edge-to-edge repair, which approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device.
The system is designed for maneuverability and stability as well as enabling precise navigation and implant delivery, the company said.
The Pascal Precision System also has CE mark certification for the treatment of both mitral and tricuspid regurgitation. The company said patients receiving treatment with the system in the U.S. will be enrolled in the Transcatheter Valve Therapy (TVT) Registry for five years.
The registry, created through a collaboration between the Society of Thoracic Surgeons and the American College of Cardiology, monitors patient safety and real-world outcomes related to transcatheter valve replacement, repair procedures and emerging treatments for valve disease patients.