Penumbra system receives Shonin approval in Japan for use in the revascularisation of acute ischaemic stroke patients


Penumbra announced the Shonin approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) of the Penumbra system for revascularisation of patients with acute ischaemic stroke. Penumbra, together with its exclusive distribution partner, Medico’s Hirata will begin immediate commercialisation of the device in Japan. 

“I am pleased that the Penumbra system was approved and will now be available for use in Japan. I believe the Penumbra system’s ability to restore flow quickly and easily will contribute significantly to Japanese stroke therapy,” said Nobuyuki Sakai, director, Neurosurgery and Stroke Center at Kobe City Medical Center General Hospital, Japan.

“I am very happy that our hard work with the MHLW has resulted in this expedited Shonin approval for the Penumbra system in Japan. The Penumbra system is a very important tool for us, and a new method for treating large vessel occlusions causing acute stroke,” said Toshio Hyogo, chief, department of Neurosurgery at Nakamura Memorial Hospital in Sapporo, Japan.

The Penumbra system is used to remove occlusions from the large vessels of the brain that are causing an acute ischaemic stroke. It works on the proximal surface of the occlusion, optimising safety and eliminating the need for navigation beyond the occlusion. The Penumbra system is a platform of devices that are size-matched to the specific neurovascular anatomy allowing clots to be gently aspirated out of intracranial vessels. It has been commercially available worldwide for four years and is now used in the majority of all interventionally treated patients with acute ischaemic stroke.