The US Food and Drug Administration (FDA) has given 510(k) clearance to the ZOOM aspiration system (Imperative Care), a family of products designed to facilitate clot removal during ischaemic 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, a press release states. The ZOOM reperfusion catheters come in four sizes (0.071”, 0.055”, 0.045”, and 0.035” internal diameter) and are designed to enable smooth tracking through challenging vasculature.
The ZOOM reperfusion catheters complement Imperative Care’s line of access catheters. According to a company press release, these access catheters enable 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,” comments Aquilla Turk, 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 revascularisation of patients with acute ischaemic 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.