FDA clears device to remove blood clots from the brain in patients experiencing an ischemic stroke

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."

"Our goal has been to develop a straightforward technology that will change how stroke is treated around the world," said Gary Curtis, President and CEO of Concentric Medical. "In the US alone, stroke rates are increasing as our population ages, and costing the US economy an estimated $53 billion annually. By working with stroke centers to increase public awareness of the Merci Retriever and stroke symptoms, we expect to greatly improve stroke management."

According to the American Heart Association, stroke killed 163,538 people in 2001 and is the leading cause of serious, long-term disability in the US. It is also the third largest cause of death, ranking behind heart disease and all forms of cancer. Research indicates approximately 500,000 Americans suffer a new stroke each year and 200,000 have a recurrent stroke. By 2050, an estimated one million will have strokes annually.