Healthcare Industry News:  neuroradiology 

Devices Neurology Interventional FDA

 News Release - January 7, 2008

Penumbra, Inc. Announces 510(k) Clearance of the Penumbra System(TM) for Use in the Revascularization of Patients With Acute Ischemic Stroke

Device to Be Available for Immediate Commercialization; Clinical Data From 125 Patient Pivotal Trial to Be Released at the ASA International Stroke Conference in New Orleans on February 22, 2008

SAN LEANDRO, Calif.--(HSMN NewsFeed)--Penumbra, Inc. today announced the 510(k) clearance by the US Food and Drug Administration of the Penumbra System, which is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within 8 hours of symptom onset. Penumbra will commence the immediate commercialization of the device in the United States.

“We were very impressed with the performance and efficacy of the Penumbra System during the clinical trial, and are excited to now have access to this important tool to treat acute ischemic stroke patients in our daily practice. This system of tools is an important advance that may transform the acute treatment of this devastating disease,” said Michael Madison, MD, Director of Interventional neuroradiology, St. Paul Radiology in St. Paul, Minnesota.

“Acute ischemic stroke is a major public health issue and its treatment often requires a variety of therapeutic approaches. We welcome the addition of the Penumbra System to the therapeutic options available to the neuro interventionalist, and look forward to seeing it in clinical practice,” said Mary E. (Lee) Jensen, M.D. Professor of Radiology and Neurosurgery at the University of Virginia Health System in Charlottesville, Virginia, and President of the Society of NeuroInterventional Surgery.

Clinical results from the pivotal trial of the Penumbra System have been accepted for presentation at the 2008 ASA International Stroke Conference in New Orleans. The abstract was accepted under the Late Breaking Science category and will be presented by Dr. Cameron McDougall, Chief of Endovascular Neurosurgery at Barrow Neurological Institute, on Friday, February 22 in Plenary Session III. Based upon the American Stroke Association’s requirements, the clinical data is embargoed from public disclosure prior to presentation at the International Stroke Conference.

“Physicians treating patients with acute ischemic stroke often have limited treatment options to offer, particularly for patients presenting beyond the three-hour time window for intravenous thrombolysis. The availability of a new endovascular device system that may allow safe revascularization of occluded vessels and restoration of brain blood flow in acute ischemic stroke for up to 8 hours after symptom onset is a promising development. We look forward to additional data addressing the effect of revascularization on clinical outcome,” said Pierre Fayad, MD the Reynolds Centennial Professor and Chairman of the Department of Neurological Sciences at the University of Nebraska Medical Center in Omaha, Nebraska, and Chair-elect of the Stroke and Vascular Neurology section of the American Academy of Neurology.

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 comprised of an aspiration platform containing multiple devices that are size-matched to the specific neurovascular anatomy allowing clots to be gently aspirated out of intracranial vessels.

In the pivotal trial, in addition to the multiple aspiration devices, the system included a clot-grabbing device that was designed to be used if the aspiration devices were not successful. Based upon the results of the trial with the aspiration devices, and due to the small number of cases in which the clot-grabbing device was necessary, Penumbra, in consultation with the FDA, decided to exclude the clot-grabbing device from its final submission.

The Penumbra System is CE Marked and has been commercially available in Europe since June, 2007.

ABOUT PENUMBRA

Penumbra, Inc. (www.penumbrainc.com) is a medical device company committed to delivering clinically beneficial products that help patients suffering from stroke and neurovascular disease. Penumbra’s global headquarters is located in the east San Francisco Bay city of San Leandro, California with sales operations in the United States and Europe.


Source: Penumbra

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