European PROMISE Study of Penumbra System Presented at International Stroke Conference
January 25, 2018—Penumbra, Inc. announced results of the company-sponsored PROMISE study, a European registry evaluating the company's Ace reperfusion catheters and demonstrating real-world safety and efficacy of the Penumbra system with Ace 68 and Ace 64 reperfusion catheters as frontline treatment in patients with acute ischemic stroke using the ADAPT (a direct aspiration first-pass technique) approach. The results were presented at ISC 2018: the International Stroke Conference held January 24–26 in Los Angeles, California.
Peter Schramm, MD, who is with the Department of Neuroradiology, Universitatsklinikum Schleswig-Holstein in Lubeck, Germany, commented in the company's announcement, "ADAPT as a frontline approach demonstrated excellent results—both in revascularization rates and clinical outcomes. In addition, the low mortality rate and strong safety profile indicate that stroke revascularization with aspiration is safer and more effective with Ace 68 and Ace 64 than ever before."
According to the company, the prospective, single-arm, multicenter PROMISE study enrolled 204 patients across 20 European centers. Core lab–adjudicated modified treatment in cerebral infarction (mTICI) 2b–3 revascularization was achieved in 93.1% of patients, with 39.2% of patients attaining mTICI 3 revascularization.
Clinical independence, as measured by modified Rankin Score 0 to 2, was achieved in 61% of patients at 90 days. Key secondary safety-related endpoints also demonstrated excellent results (all-cause mortality at 90 days, 7.5%; symptomatic intracranial hemorrhage at 24 hours, 2.9%; embolization in new territories, 1.5%). Median procedure time, measured as groin puncture to mTICI 2b–3 revascularization, was 31 minutes (range, 20–53 min), advised the company.