Imperative Care’s Zoom 88 Support Receives FDA Clearance

July 25, 2023—Imperative Care announced FDA 510(k) clearance of its Zoom 88 large distal platform (LDP) support, which expands the company’s 0.088-inch intracranial access portfolio for enabling large-bore intracranial access. The company pairs its large-bore 0.088-inch intracranial access technology with angled-tip aspiration catheters for reperfusion in stroke procedures.

The company also announced the successful completion of initial cases using Zoom 88 support, which was used during treatment of an acute stroke in a patient with a tandem occlusion that required intracranial access with improved proximal support.

One of the first Zoom 88 support cases was performed by Harris Hawk, MD, an interventional neuroradiologist at Erlanger Health System in Chattanooga, Tennessee. The patient arrived at the hospital with a debilitating National Institute of Health Stroke Scale score of 20 and returned to a baseline score of 0 the day after treatment.

In the case, Zoom 88 support provided 0.088-inch intracranial access from the femoral artery, allowing the physician to treat the distal occlusion using a Zoom aspiration catheter, in addition to providing a stable platform for treatment of the proximal occlusion, resulting in complete thrombolysis in cerebral infarction 3 revascularization

“Zoom 88 support provides me with a new capability for achieving intracranial access to treat a broader population of stroke patients, enabling the best possible outcome based on each patient’s anatomy,” commented Dr. Hawk in the company’s press release. “With products like Zoom 88 support, Imperative Care continues to respond to the needs of patients with much-needed solutions to help streamline stroke procedures and treat patients quickly and effectively.”

According to the company, the portfolio also includes the Zoom 88 LDP and the Zoom RDL radial access platform. The Zoom stroke solution includes four vessel-matching Zoom aspiration catheters with a unique angled tip for enhanced clot ingestion, and the powerful Zoom pump with Zoom pod for sterile-field clot capture.

All Zoom catheters are designed with the company’s TRX tip which provides 15% greater clot engagement area at the tip of the catheter with smooth tracking through challenging vasculature.

Imperative Care’s Zoom 88 support features a newly engineered support profile designed to maintain the capability of 0.088-inch intracranial access with added stability, giving physicians even more control over their thrombectomy procedures in a greater patient population, noted the company.