Imperative Care, announced U.S. FDA 510(k) clearance of its Zoom RDL Radial Access System, a radial access platform developed specifically for ischemic stroke treatment, and the company’s latest innovation in elevating stroke care.
Zoom RDL is the newest addition to Imperative Care’s Zoom Stroke Solution, 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 powerful Zoom Pump with Zoom POD for sterile-field clot capture.
First Use Case of Zoom RDL
The company also announced the successful completion of the first in-human case using Zoom RDL, which was performed by Justin Singer, MD, Neurosurgeon. 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 .088” intracranial access from the radial artery allowing the physician to remove the clot using a Zoom Aspiration Catheter and achieve complete revascularization in less than 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,” says Daniel Davis, president and COO of Imperative Care. “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.”
The introduction of Zoom RDL provides neurointerventionalists with a new option for achieving intracranial access to treat their stroke patients, enabling the best possible outcome based on an individual patient’s anatomy, according to the company.
Zoom RDL features an extended hydrophilic coating and the longest optimized vessel dilator on the market, providing a smooth introduction into the radial artery. Similar to the company’s FDA-cleared Zoom 88 Large Distal Platform for femoral access, Zoom RDL features 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 them more control over the mechanical thrombectomy procedure.
“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,” says 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.”