Imperative Care has received a green light from the FDA for its large-bore catheter to help remove stroke-causing blood clots from within the brain.
The new 510(k) clearance expands the portfolio of the company’s Zoom aspiration system to add the Zoom 88, with its 0.088 inch-wide opening, and its accompanying accessories.
Compared to the Zoom’s previously available catheters—with bore sizes ranging from 0.035 to 0.071 inches—the larger tip is able to deliver stronger suction forces, as well as attempt to remove a clot in fewer passes without having to break it into smaller pieces, or require the use of additional equipment such as stentlike clot retrievers.
In a prospective clinical trial of the Zoom system and its large-bore hardware, the study found the catheter was able to quickly reestablish oxygenated blood flow—from puncturing and entering a blood vessel in the groin to achieving a high level of reperfusion at the target in a median time of 19 minutes.
According to Imperative Care, that’s faster than a meta-analysis of collected trial data from other FDA-cleared hardware. Additionally, reperfusion was achieved in 84% of patients within three or fewer suction passes and without the use of other thrombectomy devices.
“We know that with stroke, time is the most critical factor in driving positive patient outcomes,” Ariel Sutton, executive vice president and general manager of Imperative Care’s stroke business, said in a statement. “The Zoom System is the first purpose-built technology from access to aspiration that maximizes versatility for rapid and effective procedures as validated by the Imperative Trial and previous clinical studies of the Zoom Stroke Solution.”
After collecting $260 million in venture capital funds in mid-2021, last July Imperative Care closed a series E financing set to raise up to $150 million. That round was led by Ally Bridge Group and joined by D1 Capital Partners, Amed Ventures, Bain Capital Life Sciences, Rock Springs Capital Management, Innovatus Capital Partners, Pura Vida Investments Catalio Capital Management, HealthCor Family Office, Montreux Growth Partners and INTAI Technology Corp.