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The implant and transcatheter delivery system represent Edwards’ bid to compete with Abbott and its MitraClip in the DMR treatment space.
Irvine, California-based Edwards Lifesciences designed its Pascal Precision system for precision transcatheter edge-to-edge repair (TEER) for heart valves.
The system features independent grasping, atraumatic clasp and closure and the ability to elongate. According to a news release, it enables safe and effective treatment for patients with DMR. It includes an intuitive catheter and handle for maneuverability and stability to offer precise navigation and implant delivery.
“Patients suffering with debilitating symptoms as a result of degenerative mitral regurgitation represent a large and significantly underserved group in the US,” said Bernard J. Zovighian , Edwards’ corporate VP, transcatheter mitral and tricuspid therapies. “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.”
In addition to the FDA approval, Pascal Precision holds CE mark approval for treating both mitral and tricuspid regurgitation. Pascal Precision is the company’s first transcatheter repair or replacement therapy approved for treating DMR in the U.S. Edwards plans to build evidence for the system through a U.S. registry enrolling patients for five years.
The company will present data from the CLASP IID pivotal trial on Sept. 17 at the 34th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. The study directly compares two contemporary TEER therapies.
“The mitral valve is highly complex and challenging to treat,” said Dr. Firas Zahr, associate professor of medicine, division of cardiovascular medicine, School of Medicine, Oregon Health & Science University, whose patients participated in the CLASP IID clinical trial. “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, U.S. clinicians now have an additional option for treating patients with severe mitral regurgitation.”
Truist analysts said it was possible that some of the data subsets or registry analysis in the pivotal trial results could yield insights on how Pascal Precision compares with MitraClip. Analysts Richard Newitter, David Rescott, Samuel Brodovsky and Lin Zhang said: “A slightly earlier than expected FDA approval increases our confidence that the company will be positioned to hit [the] ground running in the U.S. launch efforts on (or even potentially ahead of) plan.”
EW shares were up more than 1% to $95.71 apiece by midday trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly.
Filed Under: Cardiac Implants, Cardiovascular, Catheters, Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Replacement Heart Valves, Structural Heart Tagged With: Edwards Lifesciences, FDA
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