Edwards’ Pascal Precision System Approved in Canada to Treat Degenerative Mitral Regurgitation

July 18, 2024—Edwards Lifesciences (Canada) Inc. recently announced Health Canada approval of the company’s Pascal Precision transcatheter valve repair system to treat mitral regurgitation (MR). The device is indicated for the percutaneous reduction of significant, symptomatic MR (≥ 3+) caused by primary abnormality of the mitral apparatus (degenerative MR) in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the MR.

In 2022, the Pascal Precision system received FDA approval for the treatment of degenerative MR in the United States and CE Mark approval for the treatment of both mitral and tricuspid regurgitation in the European Union.

Edwards noted that the Pascal Precision system features independent grasping; atraumatic clasp and closure; and the ability to elongate. It enables safe and effective treatment for patients with symptomatic degenerative MR. The device’s intuitive catheter and handle provide maneuverability and stability, enabling precise navigation and implant delivery.

The company stated that data from the pivotal CLASP IID randomized controlled trial comparing two contemporary transcatheter edge-to-edge repair therapies confirmed the clinical and quality-of-life benefits of MR reduction with the Pascal system in a broad population of patients with degenerative MR. In the trial, the Pascal system achieved a freedom from major adverse events rate of 84.7% at 1 year. Additionally, the system showed significant and sustained MR reduction with 95.8% of patients achieving MR ≤ 2+ at 1 year.

“Patients suffering with debilitating symptoms due to symptomatic, degenerative MR represent a large and significantly underserved group,” commented Neil Fam, MD, in Edwards’ press release. “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 1 year of the study period.”

Dr. Fam, who is an interventional cardiologist and director of the Structural Heart Program at St. Michael’s Hospital in Toronto, Canada, added, “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.”

The 1-year results from the CLASP IID randomized trial were presented at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California. Simultaneously, the findings were published by Firas Zahr, MD, et al online in JACC: Cardiovascular Interventions.