Claret Medical on June 5 announced it has gained FDA approval for a device designed to protect patients undergoing heart-valve replacement from having a stroke, by removing debris dislodged by the procedure before it reaches the brain.
The Santa Rosa-based firm said its device, the Sentinel Cerebral Protection System, will be marketed for patients undergoing transcatheter aortic valve replacement (TAVR), a procedure that replaces a diseased heart valve.
More than 5 million Americans are diagnosed with heart-valve disease, and an estimated 80,000–85,000 TAVR procedures are performed every year in the U.S, according to John Muir Health Care Services.
Recent studies have found that almost 1 in 10 patients experience a stroke from such valve replacement. The majority of strokes occur during the procedure or within 72 hours, likely caused by debris that breaks loose from the native heart valve or aortic wall and travels towards the brain, leading to potential neurological damage.
The Sentinel Cerebral Protection System is said to be the first and only device available in the U.S. to capture and remove debris dislodged during TAVR before it reaches the brain. In trials, it reduced TAVR procedural strokes by 63 percent in the first 72 hours after the procedure, the company stated.
The first commercial uses of the device will likely be happening soon, a company spokesperson said.
“The advent of ‘protected TAVR’ is here, and we believe that Sentinel will create a paradigm shift in how TAVR patients are treated in the U.S.,” said Claret Medical President and CEO Azin Parhizgar in a statement. “The science behind the device has set a high bar for other embolic protection devices to meet, and its safety record is indisputable. By helping to reduce the occurrence of periprocedural strokes, we intend to provide patients and physicians with greater peace of mind as they approach a TAVR procedure.”
The device was evaluated in more than 1,000 patients in multiple studies, including three randomized controlled trials. More than 3,500 patients worldwide have been protected with the device to-date. It also is the only cerebral protection system commercially available in Europe and selected Asian countries, according to the company.
Strokes related to TAVR is a topic of much discussion, Sentinal’s spokesperson said. According to the Journal of the American Heart Association, in on-going discussions between doctors about measures to prevent such strokes, add-on devices such as the Sentinal is one avenue. Others include modifying the replacement-valve system themselves and pharmacology, and those will need more study.
“Strokes are devastating — they are random and unpredictable, and they are one of the biggest fears of any TAVR patient and their treating physician,” said Martin Leon, M.D., of Columbia University Medical Center New York-Presbyterian Hospital, and chairman of the Sentinal trial clinical steering committee. “Anything we can do as clinicians to reduce the risk of brain injury is extremely meaningful.”
Claret Medical, Inc., with headquarters in Santa Rosa and its European operation based in Belgium, was incorporated in 2009. It has developed other filtration devices for use during vascular procedures, although the Sentinel is its sole current product. The company has just under 40 employees, five chief officers, two board members, and according to crunchbase.com is worth $24 million. In August 2014 it announced an $18 million round of new funds to develop the cerebral protection device.