Imperative Care’s Zoom RDL Stroke-Specific Radial Access Platform Cleared by FDA for Mechanical Thrombectomy

January 4, 2023—Imperative Care, Inc. announced FDA 510(k) clearance of its Zoom RDL radial access system, which was developed specifically for ischemic stroke treatment.

Imperative Care advised that the first in-human procedure using Zoom RDL was performed by neurosurgeon Justin Singer, MD, at Spectrum Health in Grand Rapids, Michigan.

According to the company, the Zoom RDL was used during treatment of an acute stroke for a patient with a complex anatomy that would have made femoral access challenging. The Zoom RDL provided 0.088-inch intracranial access from the radial artery allowing the physician to remove the clot using a Zoom aspiration catheter and achieve complete revascularization in < 20 minutes.

In the company’s press release, Dr. Singer commented, “As we continue to advance how we care for our stroke patients and see the overwhelming benefit of performing radial interventions, it’s remarkable to have a company like Imperative Care respond with much-needed tools for a radial approach. I am impressed with the performance of the Zoom RDL in my initial experience and look forward to continuing a patient-first approach in my stroke practice. The addition of this new technology will allow me the first capability to choose the best access approach for each patient without limitations.”

Zoom RDL is part of Imperative Care’s Zoom Stroke Solution, which is the company’s ischemic stroke product portfolio that includes the Zoom 88 large distal platform (LDP) for neurovascular access; four purposefully designed vessel-matching Zoom aspiration catheters; and the Zoom Pump with Zoom Pod for sterile-field clot capture. All Zoom catheters are designed with the company’s TRX tip, which provides 15% greater clot engagement area at the tip of the catheter. The devices are designed to enable smooth tracking through challenging vasculature.

Zoom RDL features an extended hydrophilic coating and a long, optimized vessel dilator, providing a smooth introduction into the radial artery.

Similar to the company’s FDA-cleared Zoom 88 LDP for femoral access, Zoom RDL features a large 0.088-inch lumen for compatibility with large-bore aspiration catheters. The support profile is designed to reach the intracranial vasculature, allowing physicians to get higher into the brain and closer to the stroke-causing clot and giving them more control over the mechanical thrombectomy procedure, stated the company.