Healthcare Industry News: Penumbra
News Release - September 5, 2007
Penumbra, Inc. Completes Pivotal Stroke Trial of Intracranial Revascularization
Milestone Marks Progress in Extending the Time Window Available to Treat Patients Suffering From Acute Ischemic Stroke Using Novel Non-Drug Based Device PlatformsSAN LEANDRO, Calif.--(HSMN NewsFeed)--Penumbra, Inc. today announced completion of a 125 patient Penumbra Stroke Trial evaluating the Penumbra System(TM) in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. With data collection now complete, 510(k) submission to the FDA is expected this year with the results of the trial to be available in 2008.
The Penumbra System is a package of tools used by neurointerventional 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, thereby eliminating the need for navigation through or beyond the occlusion. The first component of the system is a clot debulking and aspiration platform that allows soft clots to be gently aspirated out of the vessel. The second component includes a Thrombus Removal Ring that allows hard or fibrous occlusions, such as from the heart, to be captured and extracted without the need to cross through the clot.
A total of 125 patients were enrolled in this single arm, prospective, independently monitored, core lab adjudicated Penumbra Stroke Trial at 24 centers in the US and Europe. Patient enrollment was completed on June 5, 2007, less than one year from the start of the trial, and the 3-month follow-up period is now complete. Patients could be enrolled in the trial if they arrived at the hospital within 8 hours of stroke symptom onset and were ineligible for or refractory to IV tPA therapy, among other criteria.
Prior to this Pivotal Penumbra Stroke Trial, a Phase I safety and feasibility trial was conducted at 6 international centers in Europe, treating 20 patients. All patients arrived at the hospital within 8 hours of stroke symptom onset and were suffering from complete or near-complete occlusions of at least one large artery in the brain. Of these 20 patients in the Phase I Trial, 100% (20/20) had complete, or near-complete restoration of flow at the site of primary occlusion. 42% (8/19) had a good clinical outcome as measured by functional independence or substantial improvement of stroke symptoms at 30 days. The Penumbra System is CE Marked and has been commercially available in Europe since June 2007.
"The results of the Penumbra System Phase I trial were extremely encouraging," explained Wayne Clark, MD, Professor of Neurology at Oregon Health Sciences University and Director of the Oregon Stroke Center. "We look forward to seeing the outcome from the 125 patient Pivotal Trial on this promising new mechanical thrombectomy system from Penumbra."
"I am very pleased to see this trial successfully completed," remarked Cameron McDougall, MD, Chief of Endovascular Neurosurgery at Barrows Neurologic Institute. "I have been impressed by the ability of the device to rapidly and atraumatically re-establish cerebral blood flow. The addition of a safe mechanical device that can facilitate cerebral revascularization without having to use thrombolytic drugs is a big step forward in the treatment of acute stroke."
According to the American Stroke Association, each year about 580,000 Americans suffer an ischemic stroke resulting from an obstruction within a blood vessel supplying blood to the brain. Generally, only 3-5 percent of these patients arrive at a hospital within the 3 hour time window required to receive IV drug therapy. Stroke is the No. 1 cause of disability and the No. 3 cause of death behind heart disease and cancer, killing more than 150,000 people per year in the US. In 2007 Americans will pay about $63 billion in stroke-related medical costs and disability.
ABOUT Penumbra
Penumbra, Inc. (www.Penumbrainc.com) is a medical device company focused on developing and manufacturing products to treat patients suffering from stroke and other neurovascular diseases. Penumbra's global headquarters is located in the east San Francisco Bay city of San Leandro, CA with sales operations in the United States and Europe.
Source: Penumbra
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