Since it received FDA clearance in June 2017, the Sentinel cerebral protection system (Claret Medical) has become an emerging standard of care in the USA to protect patients from the risk of stroke by capturing and removing debris associated with transcatheter aortic heart valve implantation (TAVI) before it travels to the brain. A press release reports that the system has been adopted by 50 US centres as part of its controlled rollout.
According to the press release, Sentinel has been shown to significantly reduce the risk of stroke in the first three days after TAVI by more than 60%. It is the first and only FDA-cleared device that captures and removes debris that is dislodged ubiquitously during TAVI before it can travel to the brain and potentially cause neurological and neurocognitive damage, regardless of the TAVI system used or a patient’s risk profile.
Hemal Gada (Pinnacle Health, Harrisburg, USA) led a presentation of clinical benefits of the Sentinel System at a Centers for Medicare and Medicaid Services (CMS) Town Hall meeting (13 February) 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).
Gada comments: “During the TAVI 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 millimetres in size, and can travel to the brain and cause ischaemic brain damage or stroke, as demonstrated by outcomes from the SENTINEL US and SENTINEL ULM trials.”
He adds that, at his centre, they have adopted the system as “the standard of care to protect our patients during every TAVI case”, noting they have had a “significant improvement in neurologic outcomes” since they started using the system in July 2017.
Azin Parhizgar, CEO of Claret Medical, says: “The rapid adoption of Sentinel in the USA 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 TAVI cases in the centres that have adopted it, reflecting physician belief in the patient benefits of protected TAVI.”
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. 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. 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 TAVI offers,” comments Parhizgar.