Suction device to remove blockages, open arteries studied for safety and efficacy

International Stroke Conference Late-Breaking News:

NEW ORLEANS, Feb. 22 — A mechanical system that can reopen blocked vessels after an acute ischemic stroke resulted in improvemen in those whose arteries were opened, according to late-breaking science presented at the American Stroke Association’s International Stroke Conference 2008.

The Penumbra System suctions stroke-causing blockages from large vessels. According to the device’s manufacturer, Penumbra, Inc., the system works on the closest edge of the blockage, eliminating the need to navigate through or beyond the blockage.

In the single arm, prospective Phase 2 study, “The Penumbra Stroke Trial,” researchers studied 125 patients in 24 centers in the United States and Europe.  The main criteria for entry were a National Institutes of Health Stroke Scale (NIHSS) of eight or greater, presentation within eight hours of the onset of stroke symptoms and an occlusion or blockage (TIMI blood flow 0 or I) of a treatable intracranial vessel. TIMI refers to levels of perfusion, or blood flow, with TIMI 0 being no flow and TIMI III being complete and normal flow. 

The Penumbra System reopened 82 percent of the treated vessels to a blood flow of TIMI II or III, with 41.6 percent of the patients having a favorable outcome at 30 days. A favorable outcome was defined as a four-point improvement on the NIHSS at discharge or a 30-day modified Rankin Scale of two or less.  There was bleeding in the brain that caused symptoms, called “symptomatic intracerebral hemorrhage” in 14 out of the 125 (11.2%) patients, and bleeding n the brain without symptoms in 21 out of the 125 (16.8%).

This was not a trial comparing this treatment with another treatment or with a placebo, so it could not determine the difference between this and other approaches.

“The trend for a better outcome when vessels were opened was consistently observed across all neurological and functional measures,” said Cameron McDougall, M.D., presenting author and chief of endovascular neurosurgery at Barrow Neurological Institute in Phoenix, Ariz.  “These results suggest that the Penumbra System may allow safe and effective revascularization in patients experiencing ischemic stroke secondary to large vessel occlusion.”  Statistical significance was not provided in the abstract.

In December 2007, the U.S. Food and Drug Administration granted clearance of the Penumbra System for revascularization of intracranial vessels in patients with acute ischemic stroke.   The Penumbra System has been commercially available in Europe since June 2007.

Disclosures: Consultant/medical advisory board or proctor for Boston Scientific, Cordis Neurovascular, Cardiomind, EV3, (all amounts <$5,000.)

Statements and conclusions of abstract authors that are presented at American Heart Association/American Stroke Association scientific meetings are solely those of the abstract authors and do not necessarily reflect association policy or position.  The associations make no representation or warranty as to their accuracy or reliability.

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NR08-1026 (ISC08/LB4/McDougall)

Note: This abstract will be presented at 12 p.m. CST, Fri., Feb. 22, 2008.