Imperative Care has received the US Food and Drug Administration’s (FDA) 510(k) clearance for its Zoom System, including its large-bore .088” catheter.

The approval makes it the first comprehensive stroke thrombectomy system with large-bore .088” catheters designed for access and aspiration when used with a Zoom Catheter, according to Imperative Care.

It also expands Imperative Care’s existing catheter portfolio, which includes .035” to .071” aspiration catheters, to now include the Zoom .088” catheters. These include Zoom 88, Zoom 88 Support, and TracStar, for aspiration within the Zoom System.

The Zoom Stroke Solution is designed to be a complete system for fast and effective clot removal in patients with acute ischemic stroke, from access through reperfusion.

It includes the Zoom 6F Insert Catheters, Zoom 88 and Zoom 88 Support Large Distal Platform, Zoom RDL Radial Access Platform, and Zoom 35, 45, 55, and 71 Catheters, along with the Zoom Pump, Zoom POD, and accessories.

The Zoom 6F Insert Catheters secured FDA clearance in July last year. The California-based medical technology company secured $150m from a Series E financing round in the same month.

Imperative Care said that all Zoom Catheters feature the TRX Tip, providing more clot engagement area at the catheter tip. These catheters are also designed for smooth tracking through challenging vasculature.

Imperative Care executive vice president and stroke business and general manager Ariel Sutton said: “We know that with stroke, time is the most critical factor in driving positive patient outcomes.

“The Zoom System is the first purpose-built technology from access to aspiration that maximises versatility for rapid and effective procedures as validated by the Imperative Trial and previous clinical studies of the Zoom Stroke Solution.”

The FDA approval was based on final data from the Imperative Trial. This prospective, multi-centre study, conducted at 26 US institutions, evaluated the Zoom System’s clinical benefits.

It analysed 211 patients treated with concomitant aspiration thrombectomy using two catheters.

Key results demonstrated a median time from groin puncture to modified treatment in cerebral infarction (mTICI) ≥2B reperfusion of 19 minutes.

A core-lab adjudicated rate of mTICI ≥2B reperfusion was achieved in 84% of patients within three passes or less, without using any additional thrombectomy devices.

Stent retriever rescue therapy was used in only 4.7% of cases to achieve mTICI ≥2B reperfusion.

Additionally, the core-lab adjudicated rate of symptomatic intracranial haemorrhage and the rate of independently adjudicated dissection and vessel perforation were lower than prior trials.