Imperative Care Receives FDA Clearance of the ZOOM Aspiration System

Imperative Care Inc., a company singularly dedicated to answering unsolved problems in stroke, announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ZOOM Aspiration System—a family of products designed to facilitate clot removal during ischemic stroke.
 
Imperative Care is co-founded by Dr. Nick Hopkins, a pioneer of endovascular neurointervention and founder and chief scientific officer of Jacobs Institute, and Fred Khosravi, a medtech entrepreneur who has founded more than 20 companies. The company is the 21st startup instituted by Khosravi via Incept LLC, a medical technology accelerator and development company that has successfully innovated various medical technologies that treat more than 1 million patients a year globally.The ZOOM Aspiration System includes the ZOOM Reperfusion Catheters, ZOOM Aspiration Pump, ZOOM Canister, and the ZOOM Aspiration Tubing. The ZOOM Reperfusion Catheters are designed with the TRX tip to navigate complex anatomy and optimally engage blood clots. The ZOOM Reperfusion Catheters come in four sizes (.071 in., .055 in., .045 in., and .035 in. internal diameter) and are designed to enable smooth tracking through challenging vasculature.
 
“For any ischemic stroke procedure, getting to the brain quickly with the right tools to remove clots is paramount. Imperative Care has developed a portfolio of access and aspiration catheters that work together to facilitate fast and effective clot removal,” said Ariel Sutton, executive vice president of marketing at Imperative Care. “Imperative Care is laser-focused on improving stroke management and committed to developing technologies that speed solutions to stroke across the full continuum of care. The availability of these products brings us one step closer to making that goal a reality.”
 
The ZOOM Reperfusion Catheters complement Imperative Care’s line of access catheters. These access catheters are designed to be longer and more flexible than other catheters, enabling smooth, consistent navigation deep into the blood vessels of the brain, which can be challenging because of the brain’s highly complex and tortuous vasculature.
 
“Aspiration procedures have provided a true breakthrough for treating stroke by removing clots with a high rate of first pass success,” said Aquilla “Quill” Turk, D.O., physician at Greenville Health System and chief medical officer and founding clinical advisor to Imperative Care. “Treatment options have significantly improved over the last decade, but the need for improved effectiveness and efficiency still remains. Imperative Care’s products are designed to enable first-class navigation and may improve clot ingestion, and I am excited to see the full line of products in use.”
 
The ZOOM Aspiration System is for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral— M1 and M2 segments, basilar, and vertebral arteries) within eight hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
 
Imperative Care is planning to launch the company’s portfolio of products later this year.
 
Based in Campbell, Calif., Imperative Care is speeding new answers to stroke by developing a portfolio of solutions to address the vast and urgent unmet needs in stroke care. The company is singularly dedicated to improving the way stroke is treated by advancing medical technology, equipping healthcare providers to evolve best practices and elevate the standard of care for stroke patients. Dr. Turk is one of Imperative Care’s founding clinical advisors and is a stockholder.