News | Embolic Protection Devices | September 20, 2016

Claret Medical Submits for U.S. Clearance of TAVR Cerebral Protection System

Filing based on data from the SENTINEL pivotal IDE trial

Claret Medical, Sentinal CPS, cerebral protection system, FDA marketing application, TAVR, embolic protection

September 20, 2016 – Claret Medical announced its filing of a marketing application with the U.S. Food and Drug Administration (FDA) for clearance of the Sentinel Cerebral Protection System (CPS). The Sentinel CPS is designed to protect the brain by capturing and removing debris dislodged during transcatheter aortic valve replacement (TAVR) that enters cerebral circulation and carries the potential for stroke. There are currently no cerebral embolic protection technologies available in the United States to protect TAVR patients from cerebral embolic events, according to Claret Medical.

The filing includes data from the recently completed SENTINEL pivotal investigational device exemption (IDE) trial, a prospective, randomized, controlled, blinded study of 363 TAVR patients at 19 centers in the United States and Germany. Trial endpoints included reduction in new ischemic cerebral infarcts, major adverse cardiac or cerebrovascular events, neurocognitive outcomes, and qualitative and quantitative histopathological findings. The SENTINEL trial allowed inclusion of all commercially available TAVR platforms available in the U.S.

Results from the recently published CLEAN-TAVI blinded, randomized, controlled trial in the Journal of the American Medical Association (JAMA) and the MISTRAL-C randomized, controlled trial, published in Eurointervention, showed that patients protected with the system had significantly fewer and smaller new ischemic cerebral infarcts following the procedure than unprotected patients. MISTRAL-C also demonstrated that the TAVR procedure created embolic debris in 100 percent of patients, which could have traveled to the brain if not for the protection offered by the Sentinel CPS.

Stroke continues to be a devastating complication of TAVR and other endovascular procedures. Ischemic brain infarcts have been associated with adverse neurologic and cognitive consequences, as well as dementia. In population-based studies, they have also been shown to increase the risk of future stroke by two- to four-fold.

The Sentinel CPS received the CE Mark in 2013.

For more information: www.claretmedical.com

Related Content

News | Cath Lab | February 23, 2018
February 23, 2018 — CorFlow Therapeutics AG announced that the company will present new insights into the coronary mi
Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab | November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab | November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Overlay Init