Latest news with #ImperativeTrial
Business Wire
16-07-2025
- Health
- Business Wire
Imperative Care Presents Positive Imperative Trial Data from Patients Treated with Aspiration Thrombectomy for M2 Occlusions Using the Zoom System
CAMPBELL, Calif.--(BUSINESS WIRE)-- Imperative Care, Inc. today announced a late-breaking abstract with data from the Imperative Trial evaluating aspiration with the Zoom System in stroke patients with M2 occlusions, presented at the Society of NeuroInterventional Surgery (SNIS) 2025 22nd Annual Meeting in Nashville, Tenn. 'The Imperative Trial demonstrated excellent reperfusion and safety results in patients with M2 vessel occlusions treated with the Zoom System,' said Ariel Sutton, General Manager of Imperative Care Stroke. 'Engineered as a complete solution, the Zoom Stroke System helps physicians perform their procedures swiftly, efficiently, and with confidence. We have amassed a robust portfolio of clinical data on Zoom and its benefits, and look forward to further advancing research by funding the first randomized study of aspiration thrombectomy in M2 occlusions.' Clinical data from a sub-analysis of patients with M2 occlusions enrolled in the Imperative Trial (n=65) were presented by Justin Mascitelli, M.D., UT Health San Antonio. The sub-analysis reported a median age of 69, with a median presenting NIHSS score of 13. The results demonstrated: An 88% core-lab adjudicated rate of final mTICI≥2b reperfusion. Excellent clinical outcomes at 90 days, with a 56% mRS score of 0-1, and a 62% mRS score of 0-2. A symptomatic intracranial hemorrhage (sICH) rate of 1.5% (1/65), an all-cause mortality rate of 4.6% (3/65), and an all-intracranial hemorrhage (ICH) rate of 18.5% (12/65). 'These data suggest that excellent safety and clinical outcomes can be achieved with aspiration thrombectomy in patients with M2 occlusions,' said Dr. Justin Mascitelli, UT Health San Antonio. 'The clinical community has important questions around the impact of treating MeVO and DMVO patients given the ESCAPE-MeVO and DISTAL trial data evaluating stent retriever and the best medical-based treatments. It's critical that this topic be further explored with evidence-generating studies on aspiration specifically, which I believe will undoubtedly move the field – and most importantly patient outcomes – forward.' Imperative Care will fund an investigator-initiated, randomized clinical trial comparing continuous dual aspiration thrombectomy with the Zoom Stroke System plus best medical treatment versus best medical treatment alone for M2 vessel occlusions in stroke patients. This will be the first trial to look at an aspiration approach specifically for M2 occlusions with the goal of evaluating the potential impact of aspiration thrombectomy on these patients. About the Zoom Products The Zoom System is designed to be a complete stroke system from access through reperfusion for fast and effective clot removal in patients presenting with acute ischemic stroke. Imperative Care's Zoom System consists of the Zoom 35, 45, 55, 71 Catheters, Zoom 88 Large Distal Platform, Zoom 88 Support, Zoom POD and Zoom Aspiration/Zoom POD tubing, Zoom Canister and DuoPort Canister. All Zoom Catheters are designed with an asymmetric TRX™ Tip, which provides 15% greater clot engagement area at the tip of the catheter 1 and are constructed to enable smooth tracking through challenging vasculature. For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: About Imperative Care, Inc. Imperative Care is a commercial-stage medical technology company researching, developing and manufacturing 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. 1. 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. Dr. Justin Mascitelli is a paid consultant for Imperative Care.
Business Wire
07-05-2025
- Business
- Business Wire
Imperative Care Launches its Next Innovation to Elevate Ischemic Stroke Treatment and Announces First Patients Treated with Continuous Dual Aspiration Technique
CAMPBELL, Calif.--(BUSINESS WIRE)-- Imperative Care, Inc. today announced the Zoom Stroke System has been further expanded with the launch of the Zoom DuoPort technology, which allows physicians to use the novel Continuous Dual Aspiration Technique (CDAT) on two Zoom Aspiration Catheters simultaneously from a single vacuum source. CDAT empowers physicians with enhanced aspiration control and immediate clot feedback from within the sterile field with two Zoom PODs. 'The launch of CDAT and Zoom DuoPort is the result of our direct partnership with physicians who participated in the Imperative Trial and provided feedback on the need to make their procedures more efficient when applying aspiration to two Zoom catheters at the same time,' said Ariel Sutton, EVP and GM of Imperative Care's Stroke business. 'We have introduced a full-system approach, starting with arch access and .088' intracranial access, through complete clot ingestion with asymmetric aspiration. Now, the CDAT approach allows physicians to achieve the benefits of our full system using dual aspiration.' Earlier this year, the company received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Zoom System, the first comprehensive stroke thrombectomy system to include large-bore .088' catheters indicated for both access and aspiration when used with a Zoom catheter. Clinical data from the Imperative Trial supporting clearance of the Zoom System showed that dual aspiration with Zoom is fast, effective, and safe in patients with a range of complex anatomies. Now with the introduction of CDAT and Zoom DuoPort, the Zoom System is the first and only system to enable continuous dual aspiration for stroke thrombectomy. 'Data from patients treated with dual aspiration in the Imperative Trial demonstrated a 19-minute median case time from groin puncture to mTICI ≥2B reperfusion – the fastest reported time of major prospective mechanical thrombectomy trials 1. Zoom DuoPort and the CDAT approach elevates the benefits of dual aspiration even further, with the goal of making stroke thrombectomies with the Zoom System faster, easier, and more effective,' Sutton added. In one of the first cases, performed by Dr. Hakeem Shakir, M.D., at Oklahoma University Health in Oklahoma City, the patient presented with an occlusion of the ICA-terminus. The Zoom VTK Insert Catheter was used to select the vessel, followed by access with Zoom 88. Both Zoom 88 and Zoom 71 maintained continuous dual aspiration from a single Zoom Pump, enabled by Zoom DuoPort, which resulted in a first-pass TICI 3 revascularization with clot captured in the Zoom 88 catheter. 'In this case, a first-pass TICI 3 result was made possible because of the control I was able to achieve with continuous dual aspiration. Without CDAT, an additional pass would likely have been required,' said Dr. Shakir. 'The CDAT approach using the Zoom System represents a significant clinical advancement in the field of stroke care that allows for continuous aspiration on two catheters and rapid, real-time feedback within the sterile field with Zoom POD. Prior to the introduction of Zoom DuoPort and CDAT, I would have to use two pumps to maintain aspiration, or sacrifice aspiration control with a syringe. In my experience, CDAT is a more common-sense approach to aspiration thrombectomy that streamlines the process, optimizes efficiencies and brings me immediate confidence that the stroke-causing clot has been captured.' About the Zoom Stroke System The Zoom Stroke System incorporates the Zoom System – the Zoom 35, 45, 55 and 71 catheters, Zoom 88, Zoom 88 Support, Zoom POD, Zoom Pump, Zoom DuoPort and accessories – and the Zoom 6F Insert Catheters, Zoom RDL Radial Access Platform and accessories. The Zoom Stroke System is designed to be a complete stroke system from access through reperfusion for fast and effective clot removal in patients presenting with acute ischemic stroke. All Zoom Catheters are designed with the unique TRX™ Tip, which provides 15% greater clot engagement area at the tip of the catheter 2 and are constructed to enable smooth tracking through challenging vasculature. For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: About Imperative Care, Inc. Imperative Care is a commercial-stage medical technology company researching, developing and manufacturing 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. 1. Major MT trials with reperfusion times reported: ARISE II, TIGER, PROST, SWIFT PRIME, PENUMBRA 3D, ASTER, COMPASS, DEFUSE 3, DAWN Note: individual trials are not directly comparable and data is presented for observational purposes only. 2. 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. Dr. Hakeem Shakir is a paid consultant of Imperative Care.
