Concentric Medical, a privately held medical device company, announced today it has received clearance from the US Food and Drug Administration (FDA) to market the Merci(R) Retriever. This is the first medical device cleared by the FDA to remove blood clots from the brain in patients experiencing an ischemic stroke.
An ischemic stroke occurs when a blood vessel in the brain is blocked by a blood clot which can impair brain function and cause severe disability or death. Of the 700,000 annual strokes in the US, approximately 83 percent (or 581,000) are ischemic. The Merci Retriever is a novel therapy that removes clots, restores blood flow and offers hope for ischemic stroke patients with no other options.
The FDA granted clearance after a thorough review of patient data obtained in a clinical study at 25 medical centers in the United States. The MERCI (Mechanical Embolus Removal in Cerebral Ischemia) Trial evaluated the device in 141 patients who were ineligible for a "clot-busting" drug that can only be used within three hours of stroke onset.
Physicians participating in the study navigated the Merci Retriever into the brain using standard catheterization techniques. A small puncture in the groin was used to introduce the Merci Retriever into an artery leading to the brain. Upon reaching the targeted area, the Merci Retriever is designed to restore blood flow by engaging, capturing and removing the blood clot.
"FDA clearance of the Merci Retriever heralds a new era in stroke management," said Wade Smith, MD, PhD, National Principal Investigator for the MERCI Study and Associate Professor of Neurology, University of California, San Francisco. "This is a very exciting result for all of our patients and for stroke research. We experienced some remarkable outcomes during the trial and look forward to having this available for patients experiencing devastating strokes."