Edwards Lifesciences has announced that its Pascal Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) has received US Food and Drug Administration (FDA) approval for the treatment of patients with degenerative mitral regurgitation (DMR).
Bernard Zovighian, Edwards’ corporate vice president of transcatheter mitral and tricuspid therapies, said: “Patients suffering with debilitating symptoms as a result of degenerative mitral regurgitation represent a large and significantly underserved group in the USA.
“Edwards’ 60-year history of innovation and leadership within structural heart disease positions our team well to bring the Pascal Precision system to US clinicians, supporting excellent real-world outcomes for patients.”
According to Edwards, 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 manoeuvrability and stability, enabling precise navigation and implant delivery, the company adds.
Firas Zahr, associate professor of medicine, Division of Cardiovascular Medicine, School of Medicine, Oregon Health & Science University (Portland, USA), whose patients participated in the CLASP IID clinical trial, commented: “The mitral valve is highly complex and challenging to treat. Through my participation in the CLASP IID pivotal trial, I have performed many cases with the Pascal system. With FDA approval of the Pascal system, US clinicians now have an additional option for treating patients with severe mitral regurgitation.”
Data from the CLASP IID pivotal trial, which Edwards say is the first randomised controlled trial to directly compare two contemporary TEER therapies, will be presented as a late-breaking clinical science session on 17 September at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 meeting (16–19 September 2022; Boston, USA).
The Pascal Precision system has CE Mark certification for the treatment of both mitral and tricuspid regurgitation. Patients receiving treatment with the Pascal Precision system in the US will be enrolled in the TVT registry for five years.
