Imperative Care Wins FDA Nod for Zoom Stroke System

Imperative Care has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Zoom system, a comprehensive stroke thrombectomy system that includes the first large-bore .088” catheters indicated for both access and aspiration.

The FDA nod grows the company’s portfolio of aspiration catheters to now include the Zoom .088” catheters (Zoom 88, Zoom 88 Support, and TracStar) for aspiration as part of the Zoom system. The Zoom Stroke Solution is a complete stroke system from access through reperfusion designed for fast and effective clot removal in patients presenting with acute ischemic stroke.

In July 2024, the company reported its Zoom 6F inserts catheters gained FDA clearance as well as the first cases using them.

Ariel Sutton, executive VP and GM of Imperative Care’s Stroke business, said the company focuses on developing a patient-centric and well-studied comprehensive stroke system so physicians can provide the best care based on their patients’ specific needs and anatomy.

“We know that with stroke, time is the most critical factor in driving positive patient outcomes,” Sutton told the press. “The Zoom System is the first purpose-built technology from access to aspiration that maximizes versatility for rapid and effective procedures as validated by the Imperative Trial and previous clinical studies of the Zoom Stroke Solution. Thank you to all the physicians, patients and their families who participated in this landmark trial and placed their trust in our technology.”

Data supporting the FDA clearance

The Imperative Trial took place in 26 institutions, with a cohort of 211 patients who were treated with concomitant aspiration thrombectomy using two catheters.

Key results included:

• Median time from groin puncture to mTICI ≥2B reperfusion of 19 minutes
• A core-lab adjudicated rate of mTICI ≥2B reperfusion was achieved in 84% of patients within three passes or less without the use of any additional thrombectomy devices as rescue therapy
• Stent retriever rescue therapy used in only 4.7% of cases to achieve mTICI ≥2B reperfusion
• A core-lab adjudicated rate of symptomatic intracranial hemorrhage of 0.9% and a rate of independently adjudicated dissection and vessel perforation of 0.5%

“In addition to the remarkable efficacy of the Zoom System, I was impressed by the demonstrated safety profile as evidenced by a 0.5% instance of serious vessel injury reported in the study. Even more impressive was the 0.9% rate of symptomatic intracranial hemorrhage,” said Dr. William Mack, M.D., Professor of Neurosurgery at the Keck School of Medicine, University of Southern California and Co-Principal Investigator of the Imperative Trial. “These data, combined with our extensive experience with the Zoom System, reinforce our confidence in the technology and its clinical benefits for our practice and the patients we treat.”