Penumbra said it won Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Penumbra Coil 400 intracranial aneurysm device.
The Alameda, Calif.-based medical device company said it plans to launch the device immediately via an exclusive distribution agreement with Japan’s Medico’s Hirata.
The device is a platinum coil that is placed into a brain aneurysm through the blood vessels, according to a press release.
The Penumbra clot-removal system won Japanese regulatory approval for treating ischemic stroke in June of last year.
Penumbra recalled another coil in April 2011 after the FDA said a pull wire on the delivery tool can slip out of place and allow premature detachment of the coil. That could cause the coil to slip into the blood stream and lead to serious injury including blood clots and stroke.