Edwards Lifesciences Canada, a subsidiary of Edwards Lifesciences Corp., has secured Health Canada approval for its Pascal Precision transcatheter valve repair system.
The system is indicated for the percutaneous reduction of significant, symptomatic mitral regurgitation (MR) due to abnormality of the mitral apparatus or degenerative MR (DMR).
It is intended for patients at prohibitive risk for mitral valve surgery, and those with existing comorbidities would not preclude the expected benefit from reduction of the MR.
The risk for surgery is determined by a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease.
According to Edwards, the Pascal Precision system will provide safe and effective treatment for DMR patients, building on its independent grasping, atraumatic clasp and closure, and ability to elongate.
The system features an intuitive catheter and a handle for manoeuvrability and stability, enabling precise navigation and implant delivery.
Edwards Lifesciences Canada managing director Frank Wuest said: “The PASCAL Precision system is one of the multiple-transcatheter repair or replacement therapies in development by Edwards that are designed to address mitral valve disease.
“Edwards is committed to transforming the treatment of mitral and tricuspid patients, supported by a robust body of clinical evidence.”
Data from the CLASP IID trial confirmed the clinical and quality-of-life benefits of mitral regurgitation (MR) reduction with the Pascal system.
CLASP IID is the first randomised controlled trial to directly compare two contemporary transcatheter edge-to-edge repair (TEER) therapies in a large population of patients with DMR.
TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device, using an approach similar to the Alfieri stitch developed in cardiac surgery.
The study showed 84.7% freedom from major adverse events, and significant and sustained MR reduction at one year, while 95.8% of patients achieved MR ≤2+ at one year.
The PASCAL Precision system received approval from the US Food & Drug Administration (FDA) for the treatment of degenerative mitral regurgitation (DMR) in 2022.
It also obtained CE mark certification for the treatment of both mitral and tricuspid regurgitation.
St Michael’s Hospital structural heart program director and interventional cardiologist Neil Fam said: “Patients suffering with debilitating symptoms due to symptomatic degenerative mitral regurgitation (DMR) represent a large and significantly underserved group.
“In the CLASP IID data, patients receiving the PASCAL system experienced significant improvements in functional capacity and quality of life that were sustained for the one year of the study period.
“With the approval of the PASCAL Precision transcatheter valve repair system, we now have a new efficient option for treating patients with severe mitral regurgitation in Canada.”
