The study is designed to assess the safety and efficacy of Zoom 88 Large Distal Platform for aspiration within eight hours of stroke onset
ZOOM Aspiration System. (Credit: Business Wire.)
Imperative Care has enrolled the first patients in Imperative Trial, a multi-centre clinical study of its Zoom 88 Large Distal Platform for the treatment of ischemic stroke.
The platform is part of Zoom Stroke Solution, alongside four Zoom aspiration catheters in various sizes, and a pump with accessories.
Zoom Stroke Solution is the company’s complete stroke system, designed for rapid and effective removal of blood clots in acute ischemic stroke patients.
Zoom 88 Large Distal Platform is intended for neurovascular access and has received the US Food and Drug Administration (FDA) approval in 2019.
It is the first study to evaluate the clinical benefits of direct aspiration for the treatment of ischemic stroke with the Zoom 88 Large Distal Platform, said the company.
Imperative Care president and COO Daniel Davis said: “At Imperative Care, the concept of elevating stroke care doesn’t end with innovative technology. We know that clinical data are foundational to validating the technology and ensuring better patient care.
“We hope that this landmark study will position direct aspiration with the Zoom 88 to become another tool that enables physicians to effectively and expeditiously treat people suffering from a stroke.”
Imperative Trial is designed to enrol 262 patients at up to 30 sites in the US.
It includes researchers from various specialities, including neurosurgery, interventional radiology, and interventional neurology, to treat ischemic stroke.
The study also aims to collect data on the clinical benefits of the complete Zoom Stroke Solution, including the Zoom 88 Large Distal Platform.
The first patient in the Imperative Trial was treated at Tampa General Hospital, affiliated with the University of South Florida in Tampa, Florida, US.
University of South Florida neurology and neurosurgery associate professor Maxim Mokin said: “I’m thrilled to have successfully treated the first patient in this study with the Zoom 88.
“This trial will help neurointerventionalists better understand the impact of large bore aspiration, particularly in regard to first pass effect and procedure time.”