Medical device makers today were quick to jump on the bandwagon after the New England Journal of Medicine today published study results showing that new-generation thrombectomy devices were superior in treating severe ischemic strokes than standard medical care with an anti-thrombosis drug.
The Dutch study, know as the Multi-center Randomized Clinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands or “Mr. Clean,” enrolled 500 patients in 16 centers in Holland. Eligible subjects had image-confirmed blockages in the anterior cerebrum that were treatable intra-arterially within 6 hours of symptom onset, according to the study.
Mr. Clean‘s primary outcome was the modified Rankin scale score at 90 days, a categorical scale measure of functional outcome, with scores ranging from 0 (no symptoms) to 6 (death), according to the study. Some 233 patients were randomly assigned to thrombectomy, with the remaining 267 assigned to usual care alone (89% of all patients were treated with the anti-thrombosis drug alteplase). Retrievable stents were used in 190 patients in the thrombectomy arm, according to the study.
The thrombectomy arm showed a 13.5% higher rate of functional independence than the medical care cohort; there were no significant differences in mortality or symptomatic intra-cerebral hemorrhage, according to the report.
“In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe," the study’s authors wrote.
Device makers wasted no time in touting the results.
"We continue to support the clinical evaluation of this breakthrough technology through several additional randomized controlled clinical trials like Swift Prime, Escape and Revascat that will look to confirm and validate the Mr. Clean results," Covidien neurovascular president Brett Wall said in prepared remarks. "We remain committed to furthering the body of clinical evidence that drives best medical practice and improved patient outcomes, and we believe that the Mr. Clean study suggests that stent thrombectomy is an important treatment option that should be made available to patients suffering from moderate to severe stroke."
"The MR CLEAN study results provide evidence to support intra-arterial treatment in the fight against stroke and have the potential to change the standard of care," noted Penumbra founder & CEO Adam Elsesser. "Penumbra is proud to have supported the MR CLEAN trial, and these important results will aid our efforts to improve access to intra-arterial treatment for the millions of stroke patients around the world."
"We recently received validation of our tireless efforts in the form of the prestigious Prix Galien award for Best Medical Technology in 2014 and today’s publication adds even more fuel to the fire. Our focus on innovation and our continued promise to complete stroke care is paying off – we are q step closer to winning the battle against stroke and we are incredibly proud that the Trevo Retriever is playing an instrumental role," Stryker neurovascular president Mark Paul said in a statement.