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Imperative Care wins FDA nod for stroke catheter

Imperative Care announced today that the FDA granted 510(k) clearance for its Zoom 6F insert catheters for ischemic stroke procedures.

The company also announced the successful completion of the first case with the Zoom 6F insert catheters. Dr. Dana Tomalty performed the case at Huntsville Hospital in Huntsville, Alabama.

Tomalty used the catheter to quickly select the target vessel and provide intracranial access from the femoral artery in a patient with a challenging anatomy and distal left M2 occlusion. Tomalty then aspirated and removed the clot in just 10 minutes from puncture to reperfusion. This resulted in a complete TICI 3 revascularization.

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