Study Links Zoom Reperfusion System to Lower Rescue Therapy Rates

Imperative Care Inc.’s Zoom Reperfusion System has lower rescue therapy rates (compared to other study results), a rapid reperfusion time, and high reperfusion rates, according to clinical trial data.   

The company’s prospective, multi-center Imperative trial evaluated Zoom Reperfusion System’s clinical benefits, including aspiration with 0.088” catheters for ischemic stroke treatment.* 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. The company established pre-specified performance goals in conjunction with the U.S. Food and Drug Administration (FDA), and 254 patients completed follow-up at 90 days.
 
“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 Solution,¹ 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.”
 
Study results show the core-lab adjudicated rate of mTICI ≥2B reperfusion within ≤3 passes without any additional thrombectomy devices use; rescue therapy was achieved in 82.2% of patients (213/259), which is similar to prior trials used to support FDA 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).

“We are pleased with the preliminary results of the Imperative Trial,” Imperative Care Chairman/CEO Fred Khosravi stated. “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.”
 
Data showed a 19-minute median time from groin puncture to mTICI ≥2B reperfusion using the Zoom Reperfusion System. 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

 

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READ MORE: Imperative Care’s Zoom Aspiration Catheters Lead to Successful Reperfusion

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“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 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.. “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.”
 
The Zoom Stroke Solution is a complete stroke system from access through reperfusion for fast, effective clot removal in patients presenting with acute ischemic stroke. The system includes an 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 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. 
 
Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for people affected by vascular diseases such as stroke and pulmonary embolism. The Campbell, Calif.-based company is focused on addressing specific gaps in treatment and care. 
 
*  Investigational device, limited by federal law to investigational use. Aspiration with Zoom 88 is not cleared by the FDA.

References 
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.