FDA OKs Imperative Care’s Zoom RDL Stroke-Specific Radial Access Platform

Imperative Care has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Zoom RDL radial access system, a radial access system developed for ischemic stroke treatment.
 
Zoom RDL is the newest entrant into the company’s Zoom Stroke Solution, an ischemic stroke product portfolio that includes the Zoom 88 Large Distal Platform (LDP) for neurovascular access, four vessel-matching Zoom Aspiration Catheters, and the Zoom Pump with Zoom POD for sterile-field clot capture.
 
The company’s first-in-human case using Zoom RDL was also successfully completed, performed by Dr. Justin Singer, MD, a neurosurgeon at Spectrum Health in Grand Rapids, Mich. It was used during treatment of an acute stroke for a patient with a complex anatomy that would’ve made femoral access difficult.
 
Zoom RDL offered .088” intracranial access from the radial artery so the clot could be removed using a Zoom aspiration catheter and have complete revascularization in under 20 minutes.
 
“We are excited to offer a new capability in our patient-first portfolio, empowering physicians with both femoral and radial access options to care for their patients for the best possible outcomes,” Daniel Davis, president and COO of Imperative Care told the press. “We are committed to providing meaningful solutions that directly address the feedback and needs of physicians through continued innovation of the Zoom Stroke Solution. A radial approach can be beneficial for patients with unfavorable femoral access and can make access site recovery easier for the patient.”
 
Zoom RDL has an extended hydrophilic coating and the longest optimized vessel dilator on the market (according to the company), providing smooth introduction into the radial artery. Similar to the company’s FDA-cleared Zoom 88 Large Distal Platform for femoral access, Zoom RDL has a large .088” lumen for compatibility with large-bore aspiration catheters. With an engineered support profile designed to reach the intracranial vasculature, physicians can get higher into the brain and closer to the stroke-causing clot, giving more control over the mechanical thrombectomy.
 
“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,” said Dr. Singer. “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.”