Imperative Care’s Zoom RDL Stroke-Specific Radial Access Platform for Mechanical Thrombectomy Evaluated in Single-Center Study

June 8, 2023—Imperative Care, a medical technology company developing connected innovations for stroke and other ischemic diseases, announced the publication of early clinical data from a single-center evaluation of the company’s Zoom RDL radial access system.

According to the company, the Zoom RDL radial access platform was developed specifically for ischemic stroke treatment to provide neurointerventionalists with an alternative option to femoral access to treat stroke patients. The device features an extended hydrophilic coating, optimized dilator, and a long distal flexible segment. It was designed to provide 0.088-inch intracranial access, which has been shown to lead to faster and better reperfusion in stroke procedures, noted the company. In January 2023, Imperative Care announced that the Zoom RDL stroke-specific radial access platform was cleared by the FDA for mechanical thrombectomy.

Data from the independent, retrospective single-center evaluation of Zoom RDL in 29 patients who underwent neurointerventional procedures from October 2022 to January 2023, indicated that the Zoom RDL radial access system is technically feasible and effective for complex neurointerventional procedures with low complication rates.

The study was published by Rami Morsi, MD, et al online ahead of print in Journal of NeuroInterventional Surgery. The study was conducted by Tareq Kass-Hout, MD, with Dr. Morsi and colleagues at the University of Chicago Medical Center in Chicago, Illinois.

As part of the evaluation, Zoom RDL was used in a range of neurointerventional procedures, with 31% (9/29) of these cases being stroke thrombectomies. The primary outcome measure of the evaluation was successful access of the target vessel without the need to convert to a different guide catheter or transfemoral access.

As summarized in the company’s press release, the results showed that access success was achieved in 90% (26/29) of cases, and in 100% (9/9) of stroke patients, with most cases resulting in thrombolysis in cerebral infarction 2c reperfusion or better within one pass (67%, 6/9). There were no access site or product-related complications reported. There were two procedure-related complications, including one intracerebral hemorrhage and one intraprocedural thrombus formation.

“Adoption of transradial access for neurointerventional procedures is at an early phase with the need for additional data supporting its use,” commented Dr. Kass-Hout in Imperative Care’s press release. “One reason behind limited adoption of transradial access, especially in mechanical thrombectomy, has been the lack of a purpose-built access catheter.”

Dr. Kass-Hout continued, “Zoom RDL fulfills this need as the first radial access catheter platform built specifically for stroke, with an inner diameter that accommodates large bore aspiration catheters and the provided ability to navigate the intracranial internal carotid artery from the radial artery.”

Imperative Care stated that the Zoom stroke solution is a complete stroke system from access through reperfusion for fast and effective clot removal in patients with acute ischemic stroke. The system includes the Zoom 88 large distal platform for neurovascular access, four vessel-matched Zoom aspiration catheters, the Zoom pump, the Zoom pod, and accessories. All Zoom catheters are designed with the TRX tip, which provides 15% greater clot engagement area at the tip of the catheter and enables smooth tracking through challenging vasculature.