FDA Clears Imperative Care's Zoom Aspiration System to Treat Ischemic Stroke
April 30, 2019–Imperative Care, Inc. announced FDA 510(k) clearance of the company’s Zoom aspiration system, which includes a family of products designed to facilitate clot removal during ischemic stroke. Imperative Care is planning to launch the company’s portfolio of products later this year.
The company stated that 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 8 hours of symptom onset. Patients who fail or are ineligible for intravenous tissue plasminogen activator are candidates for treatment.
The Zoom products include reperfusion catheters, an aspiration pump, a canister, and aspiration tubing. The Zoom reperfusion catheters feature the company's TRX tip to navigate complex anatomy and optimally engage blood clots. The catheters come in four sizes (0.071-, 0.055-, 0.045-, and 0.035-inch internal diameters) and are designed to enable smooth tracking through challenging vasculature.
According to Imperative Care, the Zoom reperfusion catheters complement the company's line of access catheters, which have a long, flexible design to enable smooth, consistent navigation deep into the brain's highly complex and tortuous blood vessels. The FDA cleared Imperative Care's access catheters in January 2019.
“Aspiration procedures have provided a true breakthrough for treating stroke by removing clots with a high rate of first pass success,” said Aquilla Turk, DO, a 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.”