Concentric Medical Receives Shonin Approval for Merci Retriever(R) in Japan

MOUNTAIN VIEW, Calif., May 4 /PRNewswire/ -- Concentric Medical, Inc., the global leader in devices for clot removal in ischemic stroke patients, today announced that the Merci Retriever®, Merci® Microcatheter, and Merci® Balloon Guide Catheter have received Shonin approval in Japan. The Merci Retriever is a catheter-based medical device that stroke centers use to remove blood clots from the brains of patients suffering an ischemic stroke. Century Medical Inc. of Japan is Concentric Medical’s distribution partner. The two companies have worked together to obtain Shonin approval.

Nobuyuki Sakai, M.D., D.M.Sc., Director, Neurosurgery & Stroke Center at Kobe General Hospital said, “The approval of the first endovascular device in Japan for acute ischemic stroke patients is a humbling reminder of the importance of a physician’s responsibility to perform endovascular treatments. Current treatment for acute ischemic stroke in Japan has been limited to IV-tPA. With the addition of the Merci Retriever as a treatment option, we have the opportunity to save more lives. In Japan, we intend to quickly establish treatment protocols with the Merci Retriever and share our clinical experience with our colleagues around the world.”

Maria Sainz, President and CEO of Concentric Medical said, “The opportunity to provide the first approved mechanical clot retrieval technology to Japanese physicians for acute ischemic stroke patients is a highly significant milestone and represents an exciting opportunity for Concentric Medical. We are committed to working closely with Japanese clinicians to help advance stroke care with the Merci Retriever. Our clinical data and experience outside of Japan gives Concentric a solid platform to successfully introduce the Merci Retriever to the Japanese market.”

Akira Hoshino, President and CEO of Century Medical said, “Over 250,000 people suffer a stroke every year in Japan. Obtaining Shonin approval for the Merci Retriever marks a great achievement in the advancement of interventional stroke care for both Japanese physicians and patients. Century Medical is committed to working with physicians and hospitals throughout Japan to make the Merci Retriever widely available for Japanese stroke patients.”

About Concentric Medical

Concentric Medical is located in Mountain View, California and is the global leader in the development of endovascular devices for revascularizing stroke patients. The company manufactures and markets solutions for ischemic stroke: minimally invasive devices that are delivered into the brain to restore blood flow by removing blood clots that cause ischemic stroke. Concentric Medical’s devices are available in over 500 leading stroke centers around the world, and have been the subject of several clinical studies. For more information about Concentric Medical, please visit www.concentric-medical.com.

About Acute Ischemic Stroke

Stroke is the third leading cause of death in the developed world and the leading cause of serious long-term disability. Ischemic stroke represents over 85% of strokes and occurs when a blockage or clot develops in one of the arteries supplying blood to the brain. In 2004 the FDA cleared Concentric Medical’s Merci Retriever® for use in patients who are ineligible for IV-tPA or who fail to respond to IV-tPA therapy. This pioneering device creates a departure from the historic method of caring for stroke patients and offers physicians and patients a long-awaited option for stroke intervention.

Media Contact: Scott Meggs, Corporate Counsel

+1 650-938-2100

strokeinfo@concentric-medical.com

MORE ON THIS TOPIC