Imperative Care Announces U.S. Clearance of the ZOOM Aspiration System
Significant milestone in company’s mission to advance stroke care
CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, Inc., a company singularly dedicated to answering
unsolved problems in stroke, today 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.
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”, .055”, .045”, and .035” Internal Diameter)
and are designed to enable smooth tracking through challenging
vasculature.
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 twenty-first start-up
instituted by Khosravi via Incept LLC, a medical technology accelerator
and development company that has successfully innovated various medical
technologies that treat more than a million patients a year globally.
“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. See Instructions for Use for complete
indications, contraindications, warnings, precautions, and adverse
events.
Imperative Care is planning to launch the company’s portfolio of
products later this year.
About Imperative Care, Inc.
Based in Campbell, Calif., Imperative Care is speeding new answers to
stroke by developing a portfolio of innovative 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. For more information,
visit http://www.imperativecare.com/.
Dr. Turk is one of Imperative Care’s founding clinical advisors and is a
stockholder.
Contacts
Jana Chow
Jana@healthandcommerce.com
925-324-9846
