Imperative Care’s Zoom 88 Large Distal Platform Evaluated for Aspiration in Ischemic Stroke

October 4, 2021—Imperative Care, Inc. announced that the first patient has been enrolled in the prospective, multicenter IMPERATIVE clinical trial, which will enroll 262 patients at up to 30 sites in the United States. The trial is designed to evaluate the clinical benefits of direct aspiration using the company’s Zoom 88 large distal platform for the treatment of ischemic stroke within 8 hours of stroke onset. The Zoom 88 device is currently cleared by the FDA for neurovascular access. It is not cleared for aspiration and is an investigational device when used for aspiration, advised the company.

Additionally, the trial will gather data on the clinical benefits of the full Zoom stroke solution, Imperative Care's ischemic stroke product portfolio that includes the Zoom 88 large distal platform for neurovascular access, four Zoom aspiration catheters in various sizes, and a pump with accessories.

According to Imperative Care, the trial is designed as multispecialty study with investigators from several specialties trained to treat ischemic stroke, including neurosurgery, interventional radiology, and interventional neurology. Principal investigators for the trial are Raul Nogueira, MD; William Mack, MD; and Reade De Leacy, MD.

Dr. Nogueira is Professor of Neurology and Radiology at Emory University School of Medicine, Atlanta, Georgia. Dr. Mack is Professor of Neurological Surgery and Director of the Neurointerventional Program at the Keck School of Medicine at the University of Southern California in Los Angeles, California. Dr. De Leacy is Associate Professor, Neurosurgery and Radiology at Mount Sinai in New York, New York.

“This is a [historic] trial which is evaluating what I consider to be the biggest breakthrough in endovascular stroke treatment since the advent of stent retrievers over a decade ago,” commented Dr. Nogueira in the company’s press release. “The 0.088-inch large-bore intracranial aspiration catheter technology may represent a paradigm shift of our first-line stroke technique strategy with the potential for full flow control, higher suction force, and complete clot ingestion.”

The first patient in the IMPERATIVE trial was treated by Maxim Mokin, MD, who is Associate Professor of Neurology and Neurosurgery at Tampa General Hospital, which is affiliated with the University of South Florida in Tampa, Florida.

Dr. Mokin stated in the press release, “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.”