January 25, 2018 – Penumbra Inc. today announced results of the company-sponsored PROMISE Study, demonstrating real-world safety and efficacy of the Penumbra System with ACE68 and ACE64 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 the International Stroke Conference (ISC 2018) in Los Angeles.
The PROMISE Study was a prospective, single-arm multi-center study that enrolled 204 patients across 20 European centers. Core-lab adjudicated mTICI 2b-3 revascularization was attained in 93.1 percent of patients, with 39.2 percent of patients attaining mTICI 3 revascularization. Clinical independence, measured by modified Rankin Score (mRS) 0-2, was achieved in 61 percent of patients at 90 days. Key secondary safety related endpoints also demonstrated excellent results: All-cause mortality at 90 days was 7.5 percent, symptomatic intracranial hemorrhage (sICH) at 24 hours was 2.9 percent and embolization in new territories (ENT) was 1.5 percent. Median procedure time, as measured as groin puncture to mTICI 2b-3 revascularization, was 31 min [20.0 – 53.0].
Results of an additional study evaluating Penumbra’s aspiration thrombectomy system for ischemic stroke revascularization using the ADAPT approach, the COMPASS Trial (A Comparison of Direct Aspiration vs. Stent Retriever as a First Approach), was presented in the main event plenary session at the International Stroke Conference.
For more information: http://www.penumbrainc.com/