California-based Penumbra’s revascularization system, for use in acute ischemic stroke patients, has received Shonin approval by the Japanese Ministry of Health, Labor and Welfare.
The Penumbra System is a platform of devices used by neuro-interventional specialists to gently remove clots from the intracranial vessels that cause acute stroke.
Kobe City Medical Center General Hospital Neurosurgery and Stroke Center director Nobuyuki Sakai said the Penumbra System’s ability to restore flow quickly and easily will contribute significantly to Japanese stroke therapy.
Nakamura Memorial Hospital in Sapporo, Japan Department of Neurosurgery chief said their hard work with the MHLW has resulted in this expedited Shonin approval for the Penumbra System in Japan.
Los Angeles, California-based endovascular neurosurgeon Satoshi Tateshima said it will be rewarding to see the Japanese neuro-interventional community share in the widespread success the Penumbra System has enjoyed in the US, Europe and other international markets.
Penumbra, along with its exclusive distribution partner, Medico’s Hirata, is set to start commercializing the device in Japan.