FDA approves Sentinel device from Claret to reduce stroke during TAVR
In a June 5 release, Claret Medical announced it had received regulatory clearance from the U.S. Food and Drug Administration for its Sentinel Cerebral Protection System. The device protects against stroke during transcatheter aortic valve replacement (TAVR) by capturing debris dislodged during the procedure.
In a randomized clinical trial, the Sentinel device reduced strokes by 63 percent in the 72 hours following TAVR, maintaining a substantial difference for 90 days. In an interview with Cardiovascular Business, James Hallums, chief commercial officer of Claret Medical, noted how previous work had shown the value of preventing debris from reaching the brain.
“What was remarkable in the Sentinel study was the size of the material that was released,” Hallums said. “If one were to understand that a middle cerebral artery in the brain, which is the largest of the intracranial anterior blood vessels, is approximately three to four millimeters in diameter, it is easy to see how these large pieces of debris can occlude atherosclerotic eccentric vessels that supply oxygen to multiple distal vascular beds in the brain.”
In reducing stroke in the 72 hours following TAVR, the Sentinel uses a dual-filter system to reduce lesions in the brain. According to the Journal of the American College of Cardiology, nearly one in 10 patients experience a stroke from debris from the heart valve or aortic wall.
The Sentinel has been evaluated in more than 1,000 patients. Some 3,500 patients in Europe and Asia have undergone TAVR with the device.
Claret Medical will immediately distribute the device to high-volume TAVR facilities in the U.S. The company is also working with CMS to find a pathway to reimbursement.
“Our goal currently is to focus on the safe and cadenced rollout of the therapy,” Hallums told Cardiovascular Business. “Our success will be based on ensuring that the message of enhanced patient safety is backed up by consistent device performance and we translate the well-established learning curve from the clinical trial into the real world of a busy TAVR program. We remain convinced that, over time, this therapy will become standard of care for TAVR in the same way that embolic protection has become standard of care in carotid stenting. “
Nicholas joined TriMed in 2016 as the managing editor of the Chicago office. After receiving his master’s from Roosevelt University, he worked in various writing/editing roles for magazines ranging in topic from billiards to metallurgy. Currently on Chicago’s north side, Nicholas keeps busy by running, reading and talking to his two cats.