Transcatheter system to treat degenerative mitral regurgitation gains FDA approval
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Edwards Lifesciences announced its precision transcatheter mitral valve repair system for edge-to-edge repair received FDA approval for the treatment of degenerative mitral regurgitation.
The system (Pascal) features independent grasping, atraumatic clasp and closure and elongation functionality enabling the treatment of degenerative mitral regurgitation, according to a company press release.
The approval is based on data from the CLASP IID pivotal trial comparing the Pascal system with a previously approved transcatheter mitral valve repair system (MitraClip, Abbott), the results of which will be presented as late-breaking clinical science on Sept. 17, 2022 at TCT 2022, the company stated in the release.
Patients in the U.S. who receive treatment of degenerative mitral regurgitation with the new system will be enrolled in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry for 5 years, according to the release.
"This system’s FDA approval will provide another option to treat the large population of patients who have degenerative mitral valve disease who are at high surgical risk, and will increase our confidence in the ability of transcatheter edge-to-edge repair to deliver good outcomes to these patients," Firas Zahr, MD, associate professor of medicine in the division of cardiovascular medicine at Oregon Health and Science University, whose patients participated in the CLASP IID clinical trial, told Healio. “This device has many unique features, including free range of steering, spacer, and the ability to elongate and retract if the device position needs to be adjusted.
“The field of transcatheter mitral valve therapies is rapidly evolving and this approval is definitely a step in the right direction,” Zahr said.
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