Healthcare Industry News:  Penumbra 

Devices Interventional Neurosurgery Regulatory

 News Release - June 17, 2011

Penumbra, Inc. Receives Shonin Approval for the Penumbra System(R) in Japan for Use in the Revascularization of Patients with Acute Ischemic Stroke

Penumbra, Inc. And Exclusive Distribution Partner Medico’s Hirata, Inc. To Begin Immediate Commercialization

ALAMEDA, Calif.--(Healthcare Sales & Marketing Network)-- Today, Penumbra, Inc. announced the Shonin approval by the Japanese Ministry of Health, Labor and Welfare of the Penumbra System for revascularization of patients with acute ischemic stroke. Penumbra, together with its exclusive distribution partner, Medico’s Hirata, Inc., will begin immediate commercialization 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, MD, DMSc, Director, Neurosurgery and Stroke Center at Kobe City Medical Center General Hospital.

“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, MD, Chief, Department of Neurosurgery at Nakamura Memorial Hospital in Sapporo, Japan.

“I am looking forward to bringing my experience with the Penumbra System to Japan to help train my colleagues there,” remarked Satoshi Tateshima, MD, PhD, Endovascular Neurosurgeon in Los Angeles, California. “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.”

The Penumbra System is a package of tools used by neuro-interventional specialists to remove occlusions from the large vessels of the brain that are causing an acute ischemic stroke. It works on the proximal surface of the occlusion, optimizing 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.

ABOUT Penumbra

Penumbra, Inc. is an independent medical device company committed to delivering clinically beneficial products that help patients suffering from stroke and other neurovascular diseases. Penumbra’s global headquarters is located in Alameda, California with sales operations in North and South America, Europe, Australia and Asia.

ABOUT Medico’s Hirata

With 90 years of history, Medico's Hirata was one of the first companies in Japan to focus on catheter intervention and the development of minimally invasive devices for use in a wide range of fields, such as endovascular treatment. The company continues to grow with the evolution of new medical technologies, and using its substantial experience and performance will continue to be a leader in technology and relationships with medical professionals.

ABOUT The Penumbra System

The Penumbra System continuous aspiration thrombectomy devices are used by neuro-interventional specialists to gently remove clots from the large vessels of the brain that are causing an acute stroke. The Penumbra System has been commercially available worldwide for four years and is now used in the majority of all interventionally treated patients with acute ischemic stroke.

Source: Penumbra

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