Concentric Medical, a provider of devices for clot removal in ischemic stroke patients, has received Shonin approval for Merci Retriever, Merci Microcatheter, and Merci Balloon Guide Catheter 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 of Japan is Concentric Medical’s distribution partner. The two companies have worked together to obtain Shonin approval.
Nobuyuki Sakai, director of 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.
“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: “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.”