Devices Interventional Radiology Neurosurgery Neurology

 News Release - October 7, 2009

Penumbra, Inc. Enrolls First Patient in the START Clinical Trial to Define Image Guided Patient Selection Criteria for Interventional Acute Ischemic Stroke Treatment

ALAMEDA, Calif.--(HSMN NewsFeed)--The Stroke Team at the Medical University of South Carolina (MUSC) in Charleston, SC, including Aquilla Turk, DO, Associate Professor of Radiology, M. Imran Chaudry, MD, Assistant Professor of Radiology, and Raymond D. Turner IV, MD, Assistant Professor of Neurosurgery and Radiology, enrolled the first patient in the Stroke Treatment And Revascularization Therapy (START) trial. The START trial aims to correlate clinical outcome after acute stroke intervention to pragmatic image guided patient selection criteria.

“The START Trial is the beginning of a scientific process to understand which acute stroke patients will benefit most from interventional therapeutic procedures. The entire Stroke Team including neurointerventional physicians often put a tremendous amount of organizational and personal effort into treating this emergency disease 24 hours per day. Using non-invasive imaging to quickly understand which patients are likely to have a good recovery will allow us to treat this devastating condition much more efficiently and aggressively,” said Dr. Turk.

The START Trial is an open-label, prospective, single arm, multi-center outcome trial of severe (NIHSS = 10) large vessel ischemic stroke in the anterior circulation with known infarct size on admission. Patients must be enrolled less than 8 hours from symptom onset. A central core lab headquartered at Massachusetts General Hospital in Boston, MA will read all imaging data.

“The use of non-invasive imaging for assessment of acute stroke patients has been a controversial topic for many years. To date, a pragmatic, easily implemented imaging criterion has not been studied and validated for widespread clinical use. The START Trial proposes to look at this issue in a rigorous way. Looking at the relevance of pre-treatment infarct core to good functional outcome may reveal just such a clinically useful criterion,” said R. Gilberto Gonzalez, MD, PhD, Professor of Radiology, Harvard Medical School; Director of Neuroradiology, Massachusetts General Hospital.

“There are hundreds of thousands of patients in the United States and around the world that suffer a large vessel ischemic stroke each year. Only a tiny fraction of them are currently treated with intra-arterial therapy. One of the reasons for this is the lack of appropriately powered, randomized data that would indicate which patients to treat, and with which therapies. The START Trial is an important step in this direction, proposing to validate simple imaging criteria that can drive patient selection. We are delighted to be a part of the START Trial, and look forward to contributing to this important effort,” said Marilyn M. Rymer, MD, Medical Director for the Saint Luke's Brain and Stroke Institute at Saint Luke's Hospital of Kansas City.

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 other neurovascular diseases. Penumbra’s global headquarters is located in Alameda, California with sales operations in the United States, Europe and Asia.

ABOUT The START Trial

The Stroke Treatment And Revascularization Therapy (START) trial aims to correlate clinical outcome after acute stroke intervention to pragmatic image guided patient selection criteria. It is an open-label, prospective, single arm, multi-center outcome trial of severe (NIHSS = 10) large vessel ischemic stroke in the anterior circulation with known infarct size on admission. Patients must be enrolled less than 8 hours from symptom onset. For more information, see: www.clinicaltrials.gov/ct2/show/study/NCT00963989.

Source: Penumbra, Inc.

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