Concentric Medical Completes Enrollment in Prospective Multi Center Stentriever(TM) Trial for Mechanical Thrombectomy in Stroke
MOUNTAIN VIEW, Calif., Sept. 8, 2011 /PRNewswire/ -- Concentric Medical, Inc., a global leader in acute ischemic stroke intervention, today announced completion of enrollment of the TREVO Study. The TREVO Study (Thrombectomy REvascularization of large Vessel Occlusions in acute ischemic stroke) is the first evaluation of Stentriever technology in a European, multicenter, prospective clinical trial. The TREVO Study was designed to assess the ability of the Trevo® System to remove the blood clots that cause strokes and to restore blood flow to the brain.
The TREVO Study employed the latest generation of the Trevo® Retrieval System and the preliminary results are very promising. Interim data from the study were presented in May at the European Stroke Congress by Professor Olav Jansen, Head of Neuroradiology at Universitatsklinikum Schleswig-Holstein Kiel. The interim revascularization rate in the first 36 patients was 96%. Thirty patients had 90-day follow up and 63% of these had a good outcome. A "good outcome" was defined as being functionally independent at 90 days (modified Rankin score of 2 or less).
Professor Olav Jansen and Professor Nils Wahlgren, Professor of Neurology at Karolinska University Hospital, are co-Principal Investigators of the Study. Professor Wahlgren commented: "The TREVO study represents an important step forward in the evidence supporting the treatment of patients with moderate and severe strokes with mechanical thrombectomy devices, such as the Trevo System. The rigorous conduct of this prospective multicenter trial provides more confidence not only in patient selection, but in the successful procedural and clinical outcomes for these patients."
"The Trevo System is the first device of this type designed specifically for removal of the clot in ischemic stroke patients. Not only was it easy to use, but the architectural properties of the device enhance clot integration into the device, making the procedures fast and remarkably effective," commented Juan Macho, MD, PhD of Hospital Clinic Barcelona.
Maria Sainz, President and CEO of Concentric Medical, commented on the importance of the study: "Clinical evidence remains key for wider adoption of interventional device-based therapies for acute ischemic stroke patients. The prospective design of the TREVO Study continues to support Concentric Medical's commitment to building robust evidence for our technologies for physicians and their stroke patients. This is an important milestone which supports the clinical efficacy of the Trevo Retrieval System. We sincerely thank all of our Principal Investigators and all other investigators for their commitment and passion in completing this significant study."
About Concentric Medical
Concentric Medical is located in Mountain View, California and is a global leader in the development of endovascular devices for revascularizing stroke patients. Concentric Medical's devices are available in over 500 leading stroke centers around the world, and have been the subject of several clinical studies.
For more information about Concentric Medical, please visit www.concentric-medical.com.
About the Trevo System
The Trevo System is an innovative, high-performing, easy-to-use thrombus retrieval system. The main component of the Trevo System is the Trevo Retriever which introduces Stentriever technology, creating a new generation of retrieval devices to remove clots in acute stroke patients. Concentric Medical is the pioneer in developing devices for ischemic stroke intervention. Since 2002, Concentric Medical's devices have been used in thousands of stroke patients worldwide. This experience has been incorporated into the design of the Trevo System to make thrombus removal an easier, faster and more predictable procedure. The new Trevo System combined with the Merci®Retriever, DAC® (Distal Access Catheters) and Balloon Guide Catheter portfolio of products further strengthens Concentric Medical's position as a global leader in acute ischemic stroke intervention.
About Acute Ischemic Stroke
Stroke is one of the leading causes of death in the developed world and the leading cause of serious long-term disability. Ischemic stroke represents over 85% of strokes and occurs when a blockage or clot develops in one of the arteries supplying blood to the brain.
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strokeinfo@concentric-medical.com
SOURCE Concentric Medical, Inc.