Imperative Care said today that it won FDA 510(k) for its Zoom aspiration system intended for removing clots during ischemic stroke.
The Zoom aspiration system includes its Zoom reperfusion catheters, aspiration pump, canister and aspiration tubing, the Campbell, Calif.-based company said. The system is designed for use in revascularizing patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within eight hours of symptom onset.
“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,” marketing exec VP Ariel Sutton said in a prepared statement.
Imperative Care said that its Zoom reperfusion catheters come in four sizes and feature a TRX tip intended to improve navigation through complex anatomy and for optimal blood clot engagement.
“Aspiration procedures have provided a true breakthrough for treating stroke by removing clots with a high rate of first pass success. 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,” chief medical officer Aquilla Turk said in a press release.
In January, Imperative Care said that it landed FDA approval for its first line of access catheters.