Sentinel Cerebral Protection System Emerging as U.S. Standard of Care for Protecting the Brain from Risk of Stroke During Transcatheter Aortic Heart Valve Replacement

VERITAS Vision System Is Introduced by Johnson & Johnson

The company will offer live demos of the new system in a wet lab at the Johnson & Johnson booth (#2813) this weekend at the 2021 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting.

GenesisCare Orders 27 Elekta Flexitron Treatment Devices

"GenesisCare continues to demonstrate its commitment to improving patient outcomes worldwide and Elekta is delighted to play a vital partnering role to achieve this mission," said Gustaf Salford, Elekta's President and CEO.

FoodMarble AIRE Shown to Exceed the Performance of ‘Gold Standard’ SIBO Testing in Clinical Trial

SIBO is a very common disorder where there are excessive bacteria present in the small intestine. The true prevalence of SIBO in the general population is largely unknown, with some studies estimating its occurrence in up to 15% of healthy individuals. It is also largely associated with many other common clinical conditions, including irritable bowel syndrome, where 40-80% of IBS patients have SIBO.

Hemal Gada, MD, of Pinnacle Health, Harrisburg, Pennsylvania said, “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.” Read on:

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.

spot_img

DON'T MISS

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.