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Medical Devices / Regulatory Affairs / Research and Development

FDA Grants IDE for Claret Medical’s Sentinel Cerebral Protection System

Feb. 20, 2014
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The FDA has granted Claret Medical an investigational device exemption for its Sentinel cerebral protection system, clearing the way clinical trials to commence, the Santa Rosa, Calif.-based devicemaker said Tuesday. The device is intended to prevent embolisms during transcatheter aortic valve replacement.

The SENTINEL trial is set to begin in the second quarter at up to 15 U.S. sites. The study will assess the device during TAVR versus standard of care in high-risk patients and patients ineligible for surgical valve replacement who are undergoing TAVR with approved valves, CEO Tony Fields told Device Daily Bulletin.

Primary endpoints will include reduction in total new lesion volume by diffusion-weighted MRI and rate of major adverse cardiac and cerebrovascular events, the devicemaker said.

The Sentinel system consists of a catheter that is inserted into the right radial artery in the right arm and threaded over the shoulder area, where it is placed at the confluence of the brachiocephalic and right common carotid arteries. It deploys two filters that capture and remove debris launched into the bloodstream during cardiac procedures that could potentially lodge in the brain and cause strokes.

Claret Medical earned a CE mark for the system in January. In addition to CE mark countries, it is available in the Czech Republic, Norway, Slovakia and Poland. — Lena Freund

The FDA has granted Claret Medical an investigational device exemption for its Sentinel cerebral protection system, clearing the way clinical trials to commence, the Santa Rosa, Calif.-based devicemaker said Tuesday. The device is intended to prevent embolisms during transcatheter aortic valve replacement.

The SENTINEL trial is set to begin in the second quarter at up to 15 U.S. sites. The study will assess the device during TAVR versus standard of care in high-risk patients and patients ineligible for surgical valve replacement who are undergoing TAVR with approved valves, CEO Tony Fields told Device Daily Bulletin.

Primary endpoints will include reduction in total new lesion volume by diffusion-weighted MRI and rate of major adverse cardiac and cerebrovascular events, the devicemaker said.

The Sentinel system consists of a catheter that is inserted into the right radial artery in the right arm and threaded over the shoulder area, where it is placed at the confluence of the brachiocephalic and right common carotid arteries. It deploys two filters that capture and remove debris launched into the bloodstream during cardiac procedures that could potentially lodge in the brain and cause strokes.

Claret Medical earned a CE mark for the system in January. In addition to CE mark countries, it is available in the Czech Republic, Norway, Slovakia and Poland. — Lena Freund