Prospective study will evaluate safety and efficacy of the Zoom 88 Large Distal Platform for aspiration within eight hours of stroke onset
CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, Inc. announced today that the first patient has been enrolled in the Imperative Trial. This prospective, multi-center clinical trial is the first study designed to evaluate the clinical benefits of direct aspiration for the treatment of ischemic stroke with the Zoom 88 Large Distal Platform, which is currently FDA cleared for neurovascular access. Additionally, the trial will gather data on the clinical benefits of the full Zoom Stroke Solution™, the company’s ischemic stroke product portfolio that includes the Zoom 88 Large Distal Platform for neurovascular access, four Zoom aspiration catheters in various sizes, and a pump with accessories.
“This is a historical trial which is evaluating what I consider to be the biggest breakthrough in endovascular stroke treatment since the advent of stent retrievers over a decade ago,” said Dr. Raul Nogueira, Professor of Neurology and Radiology at Emory University School of Medicine, Atlanta, Ga., and Principal Investigator of the Imperative Trial. “The 0.088 inch large bore intracranial aspiration catheter technology may represent a paradigm shift of our first line stroke technique strategy with the potential for full flow control, higher suction force, and complete clot ingestion.”
The first case in the Imperative Trial was performed by Dr. Maxim Mokin, Associate Professor of Neurology and Neurosurgery, at Tampa General Hospital affiliated with the University of South Florida in Tampa, Fl. “I’m thrilled to have successfully treated the first patient in this study with the Zoom 88,” said Dr. Mokin. “This trial will help neurointerventionalists better understand the impact of large bore aspiration, particularly in regard to first pass effect and procedure time.”
Designed as a multi-specialty study, the Imperative Trial will enroll 262 patients at up to 30 sites in the United States and includes investigators from several specialties trained to treat ischemic stroke, including neurosurgery, interventional radiology, and interventional neurology. Dr. Raul Nogueira is joined by two additional investigators, Dr. William Mack, Professor of Neurological Surgery and Director of the Neurointerventional Program at the Keck School of Medicine at the University of Southern California, Los Angeles, CA, and Dr. Reade De Leacy, Associate Professor, Neurosurgery and Radiology at Mt. Sinai in New York, NY.
“At Imperative Care, the concept of elevating stroke care doesn’t end with innovative technology. We know that clinical data are foundational to validating technology and ensuring better patient care,” said Daniel Davis, President and COO of Imperative Care. “We hope that this landmark study will position direct aspiration with the Zoom 88 to become another tool that enables physicians to effectively and expeditiously treat people suffering from a stroke.”
Stroke remains a largely unaddressed problem that affects over 800,000 Americans each year.1 The number of deaths due to stroke continues to rise,2 and a study published in The New England Journal of Medicine estimates that the global risk of stroke from the age of 25 years onward is approximately 25% among both men and women.3 Treatment options have significantly improved over the last decade, but the need for improved effectiveness and efficiency remains.
Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04129125).
Caution: The Zoom 88 Large Distal Platform is not cleared for aspiration and is an investigational device when used for aspiration. Limited by Federal (or United States) law to investigational use.
About the Zoom Stroke Solution
The Zoom Stroke Solution is the complete stroke system from access through reperfusion for fast and effective clot removal for patients with acute ischemic stroke. The system includes the Zoom 88 Large Distal Platform for neurovascular access, four vessel-matched Zoom Aspiration Catheters, and the Zoom Pump and accessories. All Zoom catheters are designed with the TRX™ Tip which provides 15% greater clot engagement area at the tip of the catheter and are designed 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 medical technology company focused on developing the next generation of innovative solutions to address the vast and urgent needs in stroke. The company has two 510(k) cleared product platforms, as well as an expansive stroke technology development pipeline. In addition, Imperative Care’s wholly owned subsidiary Truvic is developing solutions for the treatment of peripheral vascular disease. Imperative Care and Truvic are based in Campbell, Calif. https://imperativecare.com
1. Mozzafarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al., on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation 2016;133(4):e38–360.
2. National Center for Health Statistics Mortality Data Report for 2017
3. The GBD 2016 Lifetime Risk of Stroke Collaborators, Global, Regional and Country-Specific Lifetime Risks of Stroke, 1990 and 2016. N Engl J Med 2018; 379:2429-2437 DOI: 10.1056/NEJMoa1804492
Contacts
Investor Contact:
Matt Garrett, CFO
Imperative Care, Inc.
mgarrett@imperativecare.com
Media Contact:
Kara Hoeger
Health+Commerce
kara@healthandcommerce.com
