Penumbra Initiates THERAPY Trial for Treatment of Acute Ischemic Stroke

July 26, 2011—Penumbra, Inc. (Alameda, CA) announced immediate commencement of the THERAPY (The Randomized, Concurrent Controlled Trial to Assess the Penumbra System's Safety and Effectiveness in the Treatment of Acute Stroke) trial at the Society of NeuroInterventional Surgery 8th Annual Meeting in Colorado Springs, Colorado.

THERAPY will assess the Penumbra system of continuous aspiration thrombectomy devices as adjunctive treatment to intravenous (IV) recombinant tissue plasminogen activator (rtPA) in patients with acute ischemic stroke (AIS) from large vessel occlusion. The US Food and Drug Administration (FDA) has granted an investigational device exemption to conduct THERAPY, which is designed to prove the clinical benefit of IV treatment of AIS. J. Mocco, MD, is the trial's principal investigator.

According to the company, THERAPY is a prospective, randomized, concurrent controlled study of patients presenting with symptoms of AIS 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.

“Patient selection is the key to both clinical trial design and high quality patient care,” commented Dr. Mocco. “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 are the goals of the THERAPY trial.”

In October 2009, the company announced that the Penumbra system had been added as a therapeutic option in the combined IV/IA therapy arm of the IMS III (International Management of Stroke III) trial, a prospective, randomized, controlled, international study of acute stroke intervention funded by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health (NIH).

Pooja Khatri, MD, the trial's neurology principal investigator, added, “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 halfway 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.”

Dileep Yagaval, MD, who is president of the Society of Vascular and Interventional Neurology, commented, “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 the standard of care for our patients with acute ischemic stroke.”

In related news, Penumbra announced in June that the Japanese Ministry of Health, Labor and Welfare granted Shonin regulatory approval of the Penumbra system for the revascularization of patients with AIS. Penumbra and its exclusive distribution partner, Medico's Hirata, Inc. (Tokyo, Japan) will begin immediate commercialization of the device in Japan.