Imperative Care has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Zoom aspiration system.

Imperative

Image: ZOOM aspiration system. Photo: courtesy of Business Wire.

Zoom aspiration system is comprised of products, which will facilitate clot removal during ischemic stroke.

The system includes Zoom reperfusion catheters, Zoom aspiration pump, Zoom pump, Zoom canister and Zoom aspiration tubing.

Zoom aspiration system can be used for the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within eight hours of symptom onset.

According to the company, patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Zoom aspiration reperfusion catheters have been provided with the TRX tip for the navigation of complex anatomy and optimally engage blood clots.

The company is providing Zoom reperfusion catheters in four diameter sizes, including 071”, .055”, .045” and 035”. The catheters were designed to facilitate smooth tracking through challenging vasculature.

Zoom reperfusion catheters are said to compliment the firm’s line of access catheters that enable smooth and consistent navigation deep into the blood vessels of the brain, as it is challenging due to the brain’s complex and tortuous vasculature.

The company is planning to launch its portfolio of products by the end of this year.

Imperative Care marketing executive vice president Ariel Sutton said: “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.

“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.”

Imperative Care is co-founded by endovascular neurointervention pioneer Dr Nick Hopkins and medtech entrepreneur Fred Khosravi.

The firm is the 21 start-up established by Khosravi via Incept, a medical technology accelerator and development company that developed various medical technologies.