FDA Greenlights Imperative Care's Largest Large-Bore Stroke Catheter

Imperative Care, a leading player in stroke treatment technology, has received FDA clearance for its newest addition to the Zoom aspiration system portfolio. The Zoom 88, featuring a 0.088 inch-wide opening, represents the company's largest large-bore catheter for removing stroke-causing blood clots from the brain.

Enhanced Clot Removal Capabilities

The Zoom 88's larger tip enables stronger suction forces compared to its predecessors, which ranged from 0.035 to 0.071 inches in bore size. This advancement allows for potentially more efficient clot removal, often requiring fewer passes and reducing the need for additional equipment such as stent-like clot retrievers.

In a prospective clinical trial, the Zoom system demonstrated impressive performance:

• Median time of 19 minutes from groin puncture to achieving high-level reperfusion at the target site
• 84% of patients achieved reperfusion within three or fewer suction passes
• No additional thrombectomy devices were required in these cases

Ariel Sutton, Executive Vice President and General Manager of Imperative Care's stroke business, emphasized the importance of rapid treatment in stroke cases, stating, "We know that with stroke, time is the most critical factor in driving positive patient outcomes."

Financial Backing and Company Growth

Imperative Care's innovation in stroke treatment technology has attracted significant investor interest:

• Mid-2021: Secured $260 million in venture capital funding
• July 2022: Closed a Series E financing round, aiming to raise up to $150 million

The Series E round was led by Ally Bridge Group and included participation from notable investors such as D1 Capital Partners, Bain Capital Life Sciences, and Rock Springs Capital Management, among others.

Expanding Stroke Care Solutions

The FDA clearance of the Zoom 88 catheter further solidifies Imperative Care's position in the stroke treatment market. The company's focus on developing purpose-built technology for rapid and effective procedures aligns with the critical need for timely intervention in stroke cases.

As the company continues to innovate and expand its product portfolio, the stroke care landscape may see further advancements in treatment options and patient outcomes.