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Imperative Care Announces Clinical Data from the Pivotal Imperative Trial Evaluating the Zoom Reperfusion System for the Treatment of Ischemic Stroke
Late-Breaking Data Presented at SNIS Suggest Lower Rates of Rescue Therapy Than Prior Thrombectomy Trials; Rapid Reperfusion Time; High Rates of Reperfusion
Late-Breaking Data Presented at SNIS Suggest Lower Rates of Rescue Therapy Than Prior Thrombectomy Trials; Rapid Reperfusion Time; High Rates of Reperfusion
Imperative Care, Inc., News
CAMPBELL, Calif.--Imperative Care, Inc. announced that late-breaking data from the Imperative Trial were presented at the Society of NeuroInterventional Surgery (SNIS) 2024 21st Annual Meeting in Colorado Springs. The prospective, multi-center clinical trial evaluated the clinical benefits of the Zoom Reperfusion System, including aspiration with 0.088” catheters for the treatment of ischemic stroke.* Data from the clinical trial were presented by 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.
“At Imperative Care, we are focused on developing technologies designed for intracranial access, with the goal of enabling physicians to perform better procedures with faster clot removal using fewer devices as demonstrated in previous clinical studies of the Zoom Stroke Solution1, and now further supported by initial findings from the Imperative Trial. These data suggest this approach is poised to be better across a number of endpoints,” said Ariel Sutton, General Manager of Imperative Care’s Stroke business. “We look forward to our continued efforts to elevate stroke care through our sustained commitment to clinical evidence and meaningful innovation with the goal of improving patient outcomes.”
The study evaluated 260 patients who met inclusion and exclusion criteria and were treated across 26 U.S. institutions from October 2021 to March 2024. Pre-specified performance goals were established in conjunction with the FDA and 254 patients completed follow-up at 90 days.
Results from the trial demonstrated the core-lab adjudicated rate of mTICI ≥2B reperfusion within ≤3 passes without the use of any additional thrombectomy devices as rescue therapy was achieved in 82.2% of patients (213/259), which is similar to prior trials used to support 510(k) clearance for reperfusion indications (82.4%, 1,832/2,246).2 Stent retrieval rescue therapy achieved mTICI ≥2B reperfusion in only 5.5% of cases (13/238).
Data showed median time from groin puncture to mTICI ≥2B reperfusion using the Zoom Reperfusion System was 19 minutes. Additionally, the core-lab adjudicated rate of symptomatic intracranial hemorrhage was 2.3% (6/260), lower than the rate of prior trials (4.7%, 116/1,777)3, and the rate of independently adjudicated dissection and vessel perforation was 1.2% (3/260), similar to prior trials (1.3%, 14/933).4
“The observed data showed all three pre-specified performance goals were met. These data suggest a lower rate of rescue therapy than prior thrombectomy trials and may demonstrate that intracranial positioning of a super-large bore catheter could influence or reduce the need for stent retrieval rescue therapy as well as decrease costs,” said Dr. Mack. “Additionally, the very low rate of symptomatic intracranial hemorrhage coupled with high rates of reperfusion are promising. I look forward to the potential implications for my practice and the patients I treat.”
“We are pleased with the preliminary results of the Imperative Trial,” said Fred Khosravi, Chairman and CEO of Imperative Care. “Our mission to elevate care for patients suffering from stroke and other devastating vascular diseases extends beyond the operating room. We are happy to advance the field through our commitment to validating our innovations with robust clinical data.”
About the Zoom Stroke Solution
The Zoom Stroke Solution is the complete stroke system from access through reperfusion for fast and effective clot removal in patients presenting with acute ischemic stroke. The system includes a comprehensive access portfolio consisting of the Zoom 6F Insert Catheters, Zoom 88 and Zoom 88 Support Large Distal Platform, Zoom RDL Radial Access Platform, four vessel-matched Zoom Aspiration Catheters, Zoom Pump, Zoom POD and accessories. All Zoom Aspiration Catheters are designed with the unique TRX™ Tip, which provides 15% greater clot engagement area at the tip of the catheter5 and are designed to enable smooth tracking through challenging vasculature. For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: https://bit.ly/3yWkfEJ.
About Imperative Care, Inc.
Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for people affected by devastating vascular diseases such as stroke and pulmonary embolism. The company is focused on addressing specific gaps in treatment and care to make an impact across the entire patient journey. Imperative Care is based in Campbell, Calif. https://imperativecare.com.
*Caution: Investigational Device – Limited by Federal law to investigational use. Aspiration with Zoom 88 is not cleared.
1. Milburn J, Gulotta P, Fennell V, et al. Angled tip reperfusion catheters are associated with quicker access to final recanalization and reduced utilization of stent retrievers and secondary catheter usage in patients with emergent large vessel occlusion, which may reduce procedure cost. Journal of NeuroInterventional Surgery 2022;14:A198.
2. Meta-Analysis of 510(k) data from SWIFT PRIME, Penumbra 3D, ARISE II, TIGER, ETIS, and PROST trials. Data on file.
3. Meta-Analysis of SWIFT PRIME, MR CLEAN De Novo 510(k) data, Penumbra 3D, ARISE II, and ETIS. Data on file.
4. Meta-Analysis of SWIFT PRIME, MR CLEAN De Novo 510(k) data, Penumbra 3D, ARISE II, and PROST. Data on file.
5. Vargas J, Blalock J, Venkatraman A, et al. Efficacy of beveled tip aspiration catheter in mechanical thrombectomy for acute ischemic stroke. Journal of NeuroInterventional Surgery 2021;13:823-826.
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