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FDA: Cerebral Protection System, TAVR for Valve-in-Valve Procedures Approved
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The FDA recently cleared a cerebral protection system for patients undergoing transcatheter aortic valve replacement and approved a transcatheter heart valve for use in aortic and mitral valve-in-valve procedures.
Cerebral Protection System
The cerebral protection device (Sentinel Cerebral Protection System, Claret Medical) captures and removes debris dislodged during TAVR before it reaches the brain and is the first available in the United States for that purpose, according to a company press release.
“This is an extremely promising advent for the management of aortic stenosis and for the performance of transcatheter valve therapies,” Vinod H. Thourani, MD, co-director of Emory Heart and Vascular Center’s Structural Heart and Valve Center, professor of cardiothoracic surgery at Emory University School of Medicine, Atlanta, and an investigator on the pivotal SENTINEL trial, told Cardiology Today’s Intervention. “For the first time, we will have an adjunct technology [to assist in] decreasing morbidity. The most important morbidity that we all fear from any procedure in the CV space is stroke.”
Clearance was based in part on the SENTINEL trial, in which the device was associated with a reduction in stroke of 63% in the first 72 hours, sustained to 90 days, according to the release.
Valve-in-Valve Procedure
According to a press release from Edwards Lifesciences, its balloon-expandable valve (Sapien 3) is the first transcatheter heart valve approved in the U.S. for treatment in patients with either a failed aortic or mitral bioprosthetic valve at high risk for another open-heart procedure.
“This approval brings a safe and effective transcatheter therapy to patients who would do very poorly with repeat open-heart surgery,” John D. Carroll, MD, professor of cardiology at the University of Colorado School of Medicine and director of interventional cardiology at the University of Colorado Hospital, Denver, said in the release. – by Dave Quaile and Erik Swain
Disclosures: Carroll reports receiving research funding from Direct Flow Medical, Edwards Lifesciences and Medtronic, and serving on a data safety and monitoring board and a clinical events committee for Tendyne. Thourani reports serving as an uncompensated investigator for a trial sponsored by Claret Medical.
Perspective
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Danny Dvir, MD
These new valve-in-valve indications are important, especially for the mitral position. In the mitral position in the U.S., we basically had no indication for a less invasive transcatheter treatment for patients with a failed valve after surgery. This is especially important since redo mitral surgery is commonly a very high-risk procedure and many of these patients have cardiomyopathy and other comorbidities.
A very large set of data gathered in the VIVID registry, mostly from European sites, show that mitral valve-in-valve is a very effective procedure, and I believe that this indication is truly lifesaving for many patients that did not have good options before.
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