SANTA ROSA, Calif.--(BUSINESS WIRE)--Since FDA clearance in June 2017, the Sentinel Cerebral Protection System, developed by Claret Medical, has become an emerging standard of care in the U.S. to protect patients from the risk of stroke by capturing and removing debris associated with transcatheter aortic heart valve replacement (TAVR) before it travels to the brain. The novel system, which has been shown to significantly reduce the risk of stroke in the first three days after TAVR by more than 60 percent, has been adopted by 50 U.S. centers as part of its controlled rollout. The technology has protected more than 5,500 patients worldwide to date.
“During the TAVR procedure, we must remember that we liberate a wide spectrum of debris from the hostile aortic arch and the aortic valve complex due to the atherosclerotic nature of this disease. Some of the liberated debris is several millimeters in size, and can travel to the brain and cause ischemic brain damage or stroke, as demonstrated by outcomes from the SENTINEL U.S. and SENTINEL ULM trials,” said Hemal Gada, MD, of Pinnacle Health, Harrisburg, Pennsylvania.
Dr. Gada continued, “We have adopted the Sentinel System as the standard of care to protect our patients during every TAVR case, since the occurrence of embolic stroke is unpredictable, devastating and consequential to our patients, their caregivers and the healthcare community at large. Since the introduction of Sentinel in our center in July 2017, we have had significant improvement in neurologic outcomes.”
Dr. Gada led a presentation of clinical benefits of the Sentinel System at the February 13, 2018 Centers for Medicare and Medicaid Services (CMS) Town Hall meeting as part of the device’s approval process for gaining a New Technology Add-on Payment (NTAP) under the Medicare hospital inpatient prospective payment system (IPPS).
Azin Parhizgar, PhD., CEO of Claret Medical, said, “The rapid adoption of Sentinel in the U.S. is the result of a strong and consistent evidence base from multiple clinical studies, a superb safety profile, a highly effective training program and the inherent ease of use of the Sentinel technology. We have seen the Sentinel being used in all or the majority of TAVR cases in the centers that have adopted it, reflecting physician belief in the patient benefits of Protected TAVR. As a result, the Company has ramped manufacturing and sales significantly in the last eight months. Since the initial launch in the U.S., we have been strategically investing in growing the clinical training team and expanding our manufacturing infrastructure to meet this growing customer demand.”
Parhizgar continued, “We are proud to lead the development of the cerebral protection space in a responsible and clinically credible manner. We continue to invest in the future of the Sentinel, including clinical studies exploring its use in new indications, research and development of next generation technology, and continued patient education initiatives.”
The company also announced that Stacy Enxing Seng, a 30-year medical technology leader, has joined the company’s board of directors. She is currently a venture partner with Lightstone Ventures and a member of the board of directors for a variety of public and private companies, including The Fogarty Institute for Innovation. Ms. Enxing Seng’s extensive experience includes leading Covidien’s vascular division and ev3, as well as a variety of management roles with Boston Scientific, SCIMED Life Systems, Baxter Healthcare and American Hospital Supply.
“We are thrilled to have a medtech veteran of Stacy’s caliber join our board,” said Parhizgar. “Her deep experience and successful legacy of growing innovative, emerging companies will be invaluable as we expand the company’s commercial operations globally, while remaining focused on delivering the key patient benefits that Protected TAVR offers.”
Sentinel is the first and only FDA-cleared device that captures and removes debris that is dislodged ubiquitously during TAVR before it can travel to the brain and potentially cause neurological and neurocognitive damage, regardless of the TAVR system used or a patient’s risk profile. The SENTINEL IDE trial demonstrated that Protected TAVR with the Sentinel results in a greater than 60 percent reduction in the occurrence of periprocedural strokes.
About Claret Medical
A privately-held company, Claret Medical develops innovative solutions for cerebral protection during structural heart and vascular interventions. Believing that not all cerebral protection devices are created equal, the company developed the Sentinel dual-filter system as the only system to capture and remove debris from the patient. It has been the leader in the field of cerebral protection since 2011 and is currently the only commercialized cerebral protection device available in the U.S., Europe and Asia. For more information on Sentinel or the Company, please visit www.claretmedical.com.