EDWARDS PASCAL PRECISION TRANSCATHETER VALVE REPAIR SYSTEM RECEIVES HEALTH CANADA APPROVAL FOR SIGNIFICANT, SYMPTOMATIC MITRAL REGURGITATION

TORONTO, July 12, 2024 /CNW/ - Edwards Lifesciences (Canada) Inc today announced Health Canada's approval of the company's PASCAL Precision transcatheter valve repair system for the percutaneous reduction of significant, symptomatic mitral regurgitation.*

"Patients suffering with debilitating symptoms due to symptomatic degenerative mitral regurgitation (DMR) represent a large and significantly underserved group," said Dr Neil Fam, Interventional Cardiologist and Director of the Structural Heart Program at St Michael's Hospital, Toronto. "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."

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 maneuverability and stability, enabling precise navigation and implant delivery.

Data from the CLASP IID pivotal trial, the first randomized controlled trial to directly compare two contemporary transcatheter edge-to-edge repair (TEER) therapies, confirm the clinical and quality-of-life benefits of MR reduction with the PASCAL system in a broad population of patients with DMR. One-year results from the CLASP IID randomized trial, presented at the 35th Transcatheter Cardiovascular Therapeutics symposium of the Cardiovascular Research Foundation in October 2023, and published in JACC: Cardiovascular Interventions, showed the PASCAL system achieved:

• Freedom from major adverse events rate of 84.7 percent at one year, and
• Significant and sustained MR reduction, with 95.8 percent of patients achieving MR ≤2+ at one year.

"The PASCAL Precision system is one of 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," said Frank Wuest, Managing Director for Edwards Lifesciences in Canada.

The PASCAL Precision system received US Food & Drug Administration (FDA) approval for the treatment of DMR in 2022, in addition to CE mark certification for the treatment of both mitral and tricuspid regurgitation.

About TEER

Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve is used in the treatment of mitral regurgitation. TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stitch.

* Indications for Use

The PASCAL Precision transcatheter valve repair system is indicated for the percutaneous reduction of significant, symptomatic mitral regurgitation (MR ≥ 3+) due to 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.

About Edwards Lifesciences

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo, CLASP, Edwards PASCAL, Edwards PASCAL Precision, PASCAL, and PASCAL Precision are trademarks of Edwards Lifesciences Corporation and its affiliates. All other trademarks are the property of their respective owners. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries.

SOURCE Edwards Lifesciences

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