Imperative Care Gets FDA Clearance for ZOOM Stroke Clot Remover

Imperative Care, a company based in the Silicon Valley area, won FDA clearance for its ZOOM Aspiration System for removing stroke-causing clots. The system is designed to work particularly well with Imperative’s access catheters, which are long and highly flexible devices made to reach deep into the brain.

The ZOOM is comprised of the ZOOM Reperfusion Catheters, which feature a “TRX” tip for easier delivery, ZOOM Aspiration Pump, ZOOM Canister, and the ZOOM Aspiration Tubing. The catheters are available in four different sizes and have a special coating to facilitate their movement through blood 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, in a published statement. “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.

Here’s the exact indication that the system has been cleared for, according to Imperative Care:

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.

Link: Imperative Care homepage…

Via: Imperative Care…