Imperative Care Wins FDA OK, Has 1st Procedure with Zoom 6F Insert Catheters

Imperative Care has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Zoom 6F insert catheters. The company also revealed completion of the first case with the catheters, performed by Dr. Dana Tomalty at Huntsville Hospital in Huntsville, Alabama.

The Zoom 6F inert catheters were designed to be more supportive, more torque-able and longer than current vessel selection devices and are offered in three stroke-specific shapes. The features promote quicker vessel selection and uncompromised delivery of the company’s 0.088” intracranial access technologies—Zoom 88, Zoom 88 Support and Zoom RDL—to the intracranial anatomy.

In the first case performed by Dr. Tomalty, the Zoom SIM Insert Catheter was used to quickly select the target vessel and provide .088” intracranial access from the femoral artery with Zoom 88 in a patient with a challenging anatomy and distal left M2 occlusion. The Zoom SIM provided added stability to navigate Zoom 88 far into the brain and access the clot more quickly. Dr. Tomalty then used both Zoom 71 and Zoom 35 to aspirate and remove the clot in only 10 minutes from puncture to reperfusion, resulting in a complete TICI 3 revascularization.

“Insert catheters used for stroke today are diagnostic catheters that were designed for cardiovascular access more than 30 years ago. The Zoom 6F Insert Catheters bring physicians the modern-day tools and technologies that will allow them the opportunity to best care for their patients, bridging the innovation gap of 30 years to today’s standards for stroke treatment,” said Ariel Sutton, GM of Imperative Care’s Stroke Business.