The PASCAL system comes with independent grasping, atraumatic clasp and closure features and is developed with an intuitive catheter and handle designed to enable precise navigation and implant delivery
The PASCAL Precision transcatheter valve repair system. (Credit: Edwards Lifesciences Corporation)
Edwards Lifesciences has received the US Food and Drug Administration (FDA) approval for its PASCAL precision transcatheter valve repair system to treat patients with degenerative mitral regurgitation (DMR).
The US-based medical device maker designed the PASCAL system for transcatheter edge-to-edge repair (TEER) of the mitral valves to treat mitral regurgitation.
TEER involves grasping of the anterior and posterior mitral valve leaflets with a clipping device, mimicking a cardiac surgery technique known as the Alfieri stitch.
The PASCAL system comes with independent grasping, atraumatic clasp and closure features, along with the ability to elongate.
In addition, the system has been developed with an intuitive catheter and handle design to enable precise navigation and implant delivery, said the company.
Edwards transcatheter mitral and tricuspid therapies corporate vice president Bernard J Zovighian said: “Patients suffering with debilitating symptoms as a result of degenerative mitral regurgitation represent a large and significantly underserved group in the US.
“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.”
The PASCAL precision system is one of the company’s multiple transcatheter repair or replacement therapies in development, intended for mitral and tricuspid valve disease.
Last month, the system has been granted the CE Mark certification for the treatment of both mitral and tricuspid regurgitation.
Edwards intends to release data from the CLASP IID randomised controlled trial (RCT), which directly compared two contemporary TEER therapies, on 17 September at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.
Furthermore, patients receiving treatment with the PASCAL precision system in the US will be enrolled in the TVT registry for five years, said the company.
Oregon Health & Science University school of medicine cardiovascular division associate professor Firas Zahr said: “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.”