Healthcare Industry News: neuroradiology
News Release - July 26, 2011
Initiation of Penumbra, Inc.’s THERAPY Trial Announced at the Society of NeuroInterventional Surgery’s 8th Annual Meeting in Colorado Springs, COFDA has granted Investigational Device Exemption (IDE) approval and patient enrollment will begin immediately
ALAMEDA, Calif.--(Healthcare Sales & Marketing Network)-- The THERAPY trial, a Penumbra-sponsored groundbreaking trial designed to prove the clinical benefit of interventional treatment of acute ischemic stroke (AIS) was announced today by the trial’s Principal Investigator J Mocco, MD, MS, Assistant Professor of Neurosurgery, The University of Florida, Gainesville, FL.
“Patient selection is the key to both clinical trial design and high quality patient care. The THERAPY trial focuses on patients who are potentially responsive to aspiration thrombectomy but resistant to intravenous tPA. We believe this design can enable an efficient, cost effective, and most importantly, realistic trial. Treating patients with stroke and providing medical evidence of benefit to those patients’ clinical outcome is the goal of the THERAPY trial,” said Dr. Mocco.
“The THERAPY Trial offers the opportunity to prove that embolectomy can improve clinical outcomes in a selective patient group. It complements the more general approach of the NIH-funded 900-subject IMS III Trial. As we pass the half-way point for IMS III, and look forward to its results, we will need further definition of subpopulations that will benefit from endovascular treatments. My hope is that the stroke community will move quickly to randomize patients in these studies and get our current stroke armamentarium established on firmer ground,” said Pooja Khatri, MD, MSc., Associate Professor, University of Cincinnati Department of Neurology, Director of Acute Stroke, Greater Cincinnati/Northern Kentucky Stroke Team, and Neurology Principal Investigator.
“I enthusiastically welcome the THERAPY trial comparing endovascular thrombo-aspiration adjunctive to IV tPA, to IV tPA alone. Not only does this Phase III trial address the critical question of whether thrombo-aspiration in combination with IV tPA leads to superior functional outcomes but it also targets a specific selection criteria for endovascular therapy of AIS. The results of this trial could be widely applied as patient selection can be done with only a modern CT scanner and hence potentially have a major impact on standard of care for our patients with acute ischemic stroke,” said Dileep Yagaval, MD, Assistant Professor of Clinical Neurology and Neurosurgery / Director of Interventional Neurology, Co-Director of Endovascular Neurosurgery at the University of Miami in Miami, FL, and President of the Society of Vascular and Interventional Neurology (SVIN).
“The field of ischemic stroke intervention has seen dramatic change in the last ten years,” said Don Heck, MD, Director of Interventional neuroradiology, Forsyth Stroke and Neurosciences Center, Winston Salem, North Carolina.
“Our options have come from intra-arterial thrombolysis, which remains off-label, to a variety of FDA-approved mechanical thrombectomy devices, which are constantly undergoing further innovation and improvement. Numerous studies have demonstrated that these devices can restore flow in cerebral arteries, and yet there is no randomized trial demonstrating superior clinical outcome compared with a concurrent control group,” explained Dr. Heck.
“We have arrived at a time when devices such as the Penumbra 054 catheter are routinely opening occluded brain arteries quickly and effectively, and there is a growing skilled population of stroke interventionalists. There remains, however, lingering doubt within the stroke neurology community about the clinical effectiveness of catheter-based stroke intervention. Now is the perfect time to prove, with a randomized trial, that patients are benefitting from stroke intervention and lives are being altered for the better,” stated Dr. Heck. “I strongly believe that intervention with the Penumbra system will prove superior to intravenous t-PA alone in the THERAPY trial, but if it does not, we need to know that to guide our future efforts.”
The THERAPY trial has Investigational Device Exemption (IDE) approval from the FDA and will begin enrolling patients immediately.
THERAPY, The Randomized, Concurrent Controlled Trial to Assess the Penumbra System’s Safety and Effectiveness in the Treatment of Acute Stroke is designed to assess the Penumbra System as adjunctive treatment to IV rtPA in patients with acute ischemic stroke from large vessel occlusion. It is a prospective, randomized, concurrent controlled study of patients presenting with symptoms of acute ischemic stroke in the anterior circulation. Patients will be assigned to either IV rtPA therapy alone or a combined IV rtPA therapy and intra-arterial (IA) treatment with the Penumbra System. Each treated patient will be followed and assessed for 3 months after randomization.
ABOUT Penumbra and the Penumbra System
Penumbra, Inc. (www.penumbrainc.com) is an independent 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 North and South America, Europe, Australia and Asia.
The Penumbra System continuous aspiration thrombectomy devices are used by neuro-interventional specialists to gently remove clots from the large vessels of the brain that are causing an acute stroke. The Penumbra System has been commercially available worldwide for four years and is now used in the majority of all interventionally treated patients with acute ischemic stroke.
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