Imperative Care has announced positive data from a study of its Zoom reperfusion system, suggesting reduced rates of rescue therapy than prior thrombectomy trials, and faster and higher rates of reperfusion.
The late-breaking data was presented at the Society of NeuroInterventional Surgery (SNIS) 2024 21st Annual Meeting in Colorado Springs, US, on 24 July.
The trial demonstrated that the Zoom reperfusion system restored blood flow (mTICI 2B or higher) in 82.2% of the 259 patients enrolled within three attempts, without additional rescue devices. The median time to achieve this was 19 minutes. Rescue therapy using stent retrievers was significantly less effective, achieving success in only 5.5% of cases.
The rate of symptomatic intracranial haemorrhage was 2.3%, lower than in previous trials where it was 4.7%. Additionally, vessel-related complications occurred in 1.2% of cases, similar to 1.3% in past trials.
Imperative Care’s Zoom Stroke Solution is an all-in-one system designed for clot removal in acute ischaemic stroke patients. The portfolio includes specialised access catheters, a pump, and accessories, to assess the clot and vacuum it out. The Zoom aspiration system secured 510(k) clearance from the US Food and Drug Administration (FDA) in 2019.
The California-based company completed a reorganisation last year, restructuring into a parent company that oversees four businesses: Imperative Care Stroke, Imperative Vascular, Kandu Health and Telos Health. Each business develops a different set of technologies to improve care for strokes and other vascular diseases. Imperative completed a Series D funding round in 2021, securing $260m.
Dr William Mack, co-principal investigator of the Imperative Trial, and professor of neurosurgery at the Keck School of Medicine, University of Southern California said: “The observed data showed all three pre-specified performance goals were met.
“These data suggest a lower rate of rescue therapy than prior thrombectomy trials and may demonstrate that intracranial positioning of a super-large bore catheter could influence or reduce the need for stent retrieval rescue therapy, as well as decrease costs.”
An acute ischaemic stroke occurs when a blood clot blocks an artery in the brain, cutting off blood flow and causing brain damage. According to a report on GlobalData’s Pharma Intelligence Center, the ischaemic stroke market is forecast to be worth $10.6bn in the eight major markets (US, UK, France, Spain, Germany, Italy, Japan, and China) in 2027.
