Imperative Care’s Zoom 6F Insert Catheters Gain FDA Clearance

July 17, 2024—Imperative Care, Inc. announced FDA 510(k) clearance of its Zoom 6F insert catheters for ischemic stroke procedures. The company also advised that the first procedure with the Zoom 6F device was performed by Dana Tomalty, MD, at Huntsville Hospital in Huntsville, Alabama.

According to Imperative Care, the new Zoom 6F insert catheters are offered in three stroke-specific shapes and are designed for faster vessel selection and uncompromising delivery of the company’s 0.088-inch intracranial access technologies—Zoom 88, Zoom 88 support, and Zoom RDL—to the intracranial anatomy.

The Zoom 6F insert catheter portfolio includes the Zoom SIM, Zoom VRT, and Zoom VTK technologies, which are unique in their shape, construction, and length to help physicians achieve faster and more reliable intracranial access in a wide range of patient anatomies, stated the company.

Imperative Care reported that in the initial procedure performed by Dr. Tomalty, the Zoom SIM insert catheter was used to quickly select the target vessel and provide 0.088-inch 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 10 minutes from puncture to reperfusion, resulting in a complete TICI 3 revascularization, noted the company.

“In my experience, navigating the aortic arch can pose a significant challenge in patients with more tortuous anatomy,” commented Dr. Tomalty in the company’s press release. “Due to the unique design and capabilities of the Zoom 6F insert catheters, I believe the use of these technologies will help mitigate this challenge and take minutes off my stroke thrombectomy times, allowing me to get the clot out faster.”