Imperative Care, Inc. has announced FDA 510(k) clearance for its Zoom System, a comprehensive stroke thrombectomy system featuring large-bore 0.088-inch catheters. This clearance allows for both access and aspiration when used with a Zoom catheter, marking a significant advancement in stroke treatment options. The system's efficacy and safety were validated in the Imperative Trial, a prospective, multi-center study conducted across 26 U.S. institutions.
The Zoom System expands Imperative Care's existing portfolio of 0.035- to 0.071-inch aspiration catheters, now including the Zoom 88, Zoom 88 Support, and TracStar catheters. These are designed for aspiration as part of the Zoom system.
Clinical Trial Results
The Imperative Trial, which supported the FDA clearance, involved 211 patients treated with concomitant aspiration thrombectomy using two catheters. Key findings include:
- A median time of 19 minutes from groin puncture to mTICI ≥ 2B reperfusion, the fastest among referenced thrombectomy trials.
- An 84% rate of mTICI ≥ 2B reperfusion achieved within three passes or less without additional thrombectomy devices.
- Stent retriever rescue therapy was required in only 4.7% of cases to achieve mTICI ≥ 2B reperfusion.
- A core-lab adjudicated rate of symptomatic intracranial hemorrhage of 0.9%, lower than previous trials (4.7%).
- A rate of independently adjudicated dissection and vessel perforation of 0.5%, also lower than previous trials (1.3%).
Expert Commentary
Dr. William Mack, Professor of Neurosurgery at the Keck School of Medicine, University of Southern California, and Co-Principal Investigator of the Imperative Trial, commented on the system's safety profile: "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. 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."
The Zoom Stroke Solution
The Zoom Stroke Solution is designed for rapid and effective clot removal in acute ischemic stroke patients. It includes the Zoom 6 Fr Insert Catheters, Zoom 88 and Zoom 88 Support Large Distal Platform, Zoom RDL Radial Access Platform, the Zoom 35, 45, 55 and 71 Catheters, Zoom Pump, Zoom POD, and accessories. All Zoom Catheters feature the TRX Tip, designed for enhanced clot engagement and smooth navigation through challenging vasculature.
Ariel Sutton, EVP and GM of Imperative Care’s Stroke business, stated, "At Imperative Care, we are focused on developing a patient-centric and well-studied comprehensive stroke system for physicians to best care for their patients based on their specific needs and anatomy. We know that with stroke, time is the most critical factor in driving positive patient outcomes."
