CAMPBELL, Calif.--(BUSINESS WIRE)--Imperative Care, Inc. today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s Zoom System, making it the first comprehensive stroke thrombectomy system to include large-bore .088” catheters indicated for both access and aspiration when used with a Zoom Catheter. This clearance expands Imperative Care's current portfolio of .035” - .071” aspiration catheters to now include the Zoom .088” catheters – Zoom 88, Zoom 88 Support and TracStar – for aspiration as part of the Zoom System.
Clinical evidence submitted to the FDA to support the clearance included final data from the Imperative Trial. This prospective, multi-center clinical trial evaluated the clinical benefits of the Zoom System in patients treated across 26 U.S. institutions. The analyzed cohort included 211 patients who were treated with concomitant aspiration thrombectomy using two catheters.
“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,” said Ariel Sutton, Executive Vice President and General Manager of Imperative Care’s Stroke business. “We know that with stroke, time is the most critical factor in driving positive patient outcomes. 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.”
Key results from the Imperative Trial submitted to the FDA to support clearance demonstrated:
- Median time from groin puncture to mTICI ≥2B reperfusion of 19 minutes, fastest among the referenced thrombectomy trials.1
- A core-lab adjudicated rate of mTICI ≥2B reperfusion was achieved in 84% of patients within 3 passes or less without the use of any additional thrombectomy devices as rescue therapy, similar to prior trials (82%).2
- 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%, lower than the rate of prior trials (4.7%,)3, and a rate of independently adjudicated dissection and vessel perforation of 0.5%, lower than prior trials (1.3%).4
“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.”
About the Zoom Stroke Solution
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. The comprehensive system includes the Zoom 6F Insert Catheters, Zoom 88 and Zoom 88 Support Large Distal Platform, and Zoom RDL Radial Access Platform, the Zoom 35, 45, 55 and 71 Catheters, Zoom Pump, Zoom POD and accessories. All Zoom 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.
1. Meta-Analysis of 510(k) data from ARISE II, TIGER, Penumbra 3D, and PROST trials. Data on file.
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.
