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The US Food and Drug Administration has approved the PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) as a treatment for patients with degenerative mitral regurgitation, according to a release from Edwards Lifsciences Corporation.
Announced on September 15, the FDA’s approval is based on the results of CLASP IID pivotal trial, which Edwards Lifesciences purports is the first randomized controlled trial to directly compare two contemporary TEER therapies.
"The mitral valve is highly complex and challenging to treat," said Firas Zahr, MD, Associate Professor of Medicine, Division of Cardiovascular Medicine, School of Medicine, Oregon Health & Science University, whose patients participated in the CLASP IID clinical trial, in the aforementioned statement. “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, US clinicians now have an additional option for treating patients with severe mitral regurgitation."
Billed as latest advancement from Edwards Lifesciences in transcatheter mitral therapies, the PASCAL Precision system is designed with independent grasping, atraumatic clasp and closure, and ability to elongate to enable safe and efficacious treatment, as well as availability in 2 implant sizes to allow for adjustment to procedural needs. At the time of approval, the PASCAL Precision system had already received a CE Mark certification for treatment of both mitral and tricuspid regurgitation.
In their release, Edwards Lifesciences Corporation noted plans to present data from the pivotal CLASP IID trial at the 34th Transcatheter Cardiovascular Therapeutics (TCT). On their own website, Edwards Lifesciences pointed out the company currently investing in 5 transcatheter mitral and tricuspid pivotal trials.
"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 vice president, 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."
The Edwards Lifesciences website also notes multiple contraindications for the PASCAL Precision system, including contraindications in patients who cannot tolerate procedural anticoagulation or post procedural antiplatelet regimen, with untreatable hypersensitivity or contraindication to nitinol alloys or contrast media, with active endocarditis of the mitral valve, with rheumatic etiology for mitral regurgitation, or with evidence of intracardiac, inferior vena cava, or femoral venous thrombus.