SANTA ROSA -- A team at Claret Medical, Inc., has developed what's designed to be a feasible and safe blood filtration technique to help reduce strokes following heart valve implantation.
The company is being recognized for its leadership in medical-device manufacturing.
In February, Claret Medical (claretmedical.com) announced that it had received investigative device exemption (IDE) approval for U.S. pivotal trial of The Sentinel cerebral protection system in the transcatheter aortic valve replacement (TAVR) patient population from the U.S. Food and Drug Administration (FDA).
The company now plans to initiate a 15-center human patient study in the U.S. over eight to 10 months, followed by a 510(k) FDA review cycle. Following final FDA approval, the device would be approved for use within the U.S. The approval process considers both the type of device and an analysis of clinical data from patients that have had the procedure.
[caption id="attachment_95447" align="alignleft" width="360"] Larry Carrier (left), vice president for regulatory and clinical quality; Tony Fields, chief operating officer; and Dan Fifer, vice president for research and development, in front of Claret Medical's clean room in north Santa Rosa.[/caption]
TAVR involves delivering a new heart value tightly packaged into a catheter and typically inserted through an artery in a patient’s leg and guided to the heart.
In a similar procedure, the two Sentinel filters are remotely deployed in arteries leading from the heart to the brain.
“The Sentinel is designed to work with any cardiac intervention you can think of,” said Tony Fields, chief operating officer with Claret Medical. “While stroke is one of the most feared complications of cardiac interventions, other neuro cardiac cognitive impairing events, or deficits, can occur due to what is called silent infarct. Symptoms include short- and long-term memory loss, personality changes and a reduction in functional mobility, among others.”
He said there is big potential for Claret Medical, headed by President and CEO Azin Parhizgar, Ph.D., if their company can prove that its device can also reduce neurocognitive deficits.
[caption id="attachment_95448" align="alignright" width="315"] Claret Medical's The Sentinel filter is designed to collect debris from a transcatheter aortic heart valve replacement procedure before it can travel to the brain through the bloodstream and cause a stroke. These dual filters are placed in the carotid arteries branching from the aortic bridge leading away from the heart.[/caption]
With The Sentinel, small filters are temporarily placed inside the two carotid arteries leading to the brain from the aortic arch above the heart. These filters capture and remove debris (tissue fragments, calcium, etc.) released during TAVR, thus preventing them from traveling through the bloodstream to the brain where they can cause a stroke.
Without this next-generation dual filter-based solution, patients in need of a new heart valve have a one in 16 chance of stroke resulting from the TAVR procedure itself, because it does not utilize any form of cerebral vascular protection as a standard of care.
“Open heart surgery involves hospitalization, weeks of recovery time and often produces severe side effects,” Mr. Fields said. "Inserting a replacement valve through a patient’s artery is becoming widely accepted as a less-invasive alternative. Our procedure uses a similar transcatheter arterial delivery system to put Sentinel in place and remove it after sufficient time has passed to collect debris and mitigate the risk of stroke and neurocognitive deficit.