FDA News

Cerebral protection system cleared for use in TAVR procedures

Claret Medical announced that the FDA, via the de novo classification system, cleared its cerebral protection system for patients undergoing transcatheter aortic valve replacement.

The device (Sentinel cerebral protection system) 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 release issued by the company.

“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.”

Virnod Thourani
Vinod H. Thourani

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.

In an analysis of clinical studies, the device removed visible debris headed toward the brain in 99% of patients undergoing TAVR, regardless of replacement valve type, with no compromise in safety, the company stated in the release.

In February, the FDA’s Circulatory System Devices Panel concluded that the device is safe and, despite lack of definitive efficacy data, it appears to prevent disastrous outcomes.

Martin Leon
Martin B. Leon

“Anything we can do as clinicians to reduce the risk of brain injury is extremely meaningful,” Martin B. Leon, MD, professor of medicine at Columbia University Medical Center, director of the Center for Interventional Vascular Therapy, director of the cardiac catheterization laboratories and a member of the executive board of the Columbia NewYork-Presbyterian Heart Valve Center, founder and chairman emeritus of the Cardiovascular Research Foundation, and chairman of the SENTINEL trial’s clinical steering committee, said in the release. “The 63% reduction in clinical strokes in the first 72 hours after TAVR, combined with the fact that one in four patients had an average of 25 particles of debris collected that were visible to the naked eye, is striking. The device was delivered safely, added minimal time to the procedure and performed as intended with capture of embolic material and reduction in ischemic brain injury.”

While the SENTINEL trial was not powered to determine a reduction in clinical strokes, it did show that “a huge amount of debris going into the brain was captured with the device, which should make all of us feel better,” Thourani told Cardiology Today’s Intervention. “The capture of debris in almost every patient is a substantial finding that we will think about, especially in patients at the highest risk for stroke.”

Disclosure: Leon reports chairing the steering committee for a trial sponsored by Claret Medical and being an unpaid member of the executive committee for a trial sponsored by Edwards Lifesciences. Thourani reports serving as an uncompensated investigator for a trial sponsored by Claret Medical.

Claret Medical announced that the FDA, via the de novo classification system, cleared its cerebral protection system for patients undergoing transcatheter aortic valve replacement.

The device (Sentinel cerebral protection system) 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 release issued by the company.

“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.”

Virnod Thourani
Vinod H. Thourani

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.

In an analysis of clinical studies, the device removed visible debris headed toward the brain in 99% of patients undergoing TAVR, regardless of replacement valve type, with no compromise in safety, the company stated in the release.

In February, the FDA’s Circulatory System Devices Panel concluded that the device is safe and, despite lack of definitive efficacy data, it appears to prevent disastrous outcomes.

Martin Leon
Martin B. Leon

“Anything we can do as clinicians to reduce the risk of brain injury is extremely meaningful,” Martin B. Leon, MD, professor of medicine at Columbia University Medical Center, director of the Center for Interventional Vascular Therapy, director of the cardiac catheterization laboratories and a member of the executive board of the Columbia NewYork-Presbyterian Heart Valve Center, founder and chairman emeritus of the Cardiovascular Research Foundation, and chairman of the SENTINEL trial’s clinical steering committee, said in the release. “The 63% reduction in clinical strokes in the first 72 hours after TAVR, combined with the fact that one in four patients had an average of 25 particles of debris collected that were visible to the naked eye, is striking. The device was delivered safely, added minimal time to the procedure and performed as intended with capture of embolic material and reduction in ischemic brain injury.”

While the SENTINEL trial was not powered to determine a reduction in clinical strokes, it did show that “a huge amount of debris going into the brain was captured with the device, which should make all of us feel better,” Thourani told Cardiology Today’s Intervention. “The capture of debris in almost every patient is a substantial finding that we will think about, especially in patients at the highest risk for stroke.”

Disclosure: Leon reports chairing the steering committee for a trial sponsored by Claret Medical and being an unpaid member of the executive committee for a trial sponsored by Edwards Lifesciences. Thourani reports serving as an uncompensated investigator for a trial sponsored by Claret Medical.