MOUNTAIN VIEW, Calif., March 6 /PRNewswire/ -- Concentric Medical, Inc., the global leader in devices for clot removal in ischemic stroke patients, today announced that the results of its Multi MERCI trial will be published in the April 2008 edition of the medical journal, Stroke. The Multi MERCI trial was the second trial studying safety and efficacy of the Merci Retrieval System(TM), a "corkscrew-type" device that is delivered into the brain and is designed to restore blood flow by engaging, capturing and removing blood clots that cause ischemic stroke. The full, peer reviewed trial results are available now to online subscribers. Stroke is published by the American Heart Association.
In the Multi MERCI trial, patients treated with the newer Merci(R) L5 Retriever had their cerebral blood flow successfully restored 57.3% of the time with the Merci Retrieval System alone. With the addition of adjunctive therapy, physicians successfully restored cerebral blood flow 69.5% of the time. For patients to be successfully revascularized, not only the target vessel, but all treatable downstream vessels needed to achieve TIMI 2 or 3 flow.
In addition, a total of 36% of all patients treated achieved a "good" outcome at 90 days post procedure, a higher rate than reported in any other device trial in large vessel acute ischemic stroke patients. Ninety-day clinical outcomes in stroke trials are generally measured using the modified Rankin Score, a measure of functional independence, with a score of 2 or less considered a good outcome. These outcome data are superior to those reported in recent studies of other devices in which successful revascularization was not as stringently defined.
Multi MERCI was a multi-center, prospective trial including 164 patients treated at 15 hospitals in the United States and Canada. All patients had moderate-to-severe, large vessel ischemic strokes. The trial included patients who were ineligible for or had failed treatment with a clotdissolving drug called t-PA. Patients had treatment initiated up to eight hours after stroke symptom onset, extending the three-hour treatment window for intravenous clot-dissolving drugs.
"We are excited that both clinical outcome and recanalization rates are improved with the next-generation devices tested in the Multi MERCI Trial. This provides further evidence that timely recanalization is a surrogate marker for clinical benefit, especially when one uses the conservative definition of recanalization used in this trial," said Wade Smith, MD, PhD Professor of Neurology at the University of California, San Francisco, and Principal Investigator for the Multi MERCI trial.
About Concentric Medical
Concentric Medical is located in Mountain View, California, and was
founded in August 1999. The company manufactures and markets the Merci
Retrieval System, which is available in over 250 leading stroke centers
around the world. Concentric Medical estimates that over 7,000 patients
have been treated with its devices. For more information about Concentric
Medical, please visit http://www.concentric-medical.com.
|SOURCE Concentric Medical, Inc.|
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