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