FDA Clears First Stroke-Specific Radial Access Platform for Mechanical Thrombectomy

With this new approval, the Zoom RDL becomes the newest addition to Imperative’s Zoom Stroke Solution, a complete stroke system designed for effective clot removal in ischemic stroke.

Justin Singer, MD, neurosurgeon, Spectrum Health

Justin Singer, MD

The FDA has granted 510(k) clearance to Imperative Care’s Zoom RDL Access System, making it the first radial access platform developed specifically for treating patients with ischemic stroke. Additionally, the company also announced the successful completion of the first-in-human case using Zoom RDL.

Zoom RDL, the newest addition to Imperative’s Zoom Stroke Solution, features an extended hydrophilic coating and the longest optimized vessel dilator on the market, allowing for a smooth introduction into the radial artery. The system also includes a large .088-inch lumen for compatibility with large-bore aspiration catheters. Designed to reach the intracranial vasculature, this new approach may allow clinicians to get higher into the brain and closer to the stroke-causing clot, thus improving control throughout the procedure.

Justin Singer, MD, neurosurgeon, Spectrum Health, performed the first in-human operation using Zoom RDL on a patient with a complex anatomy that would have made femoral access challenging. The system was successful, providing .088 inches of intracranial access from the radial artery, allowing the physician to remove the clot using the vessel-matching Zoom Aspiration Catheters, also part of the Zoom Stroke System. All told, complete revascularization was achieved in less than 20 minutes.

"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,” Singer said in a statement.1 "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."

Imperative’s Zoom Stroke Solution is a complete stroke system built for clot removal that includes the Zoom 88 Large Distal Platform for neurovascular access, 4 vessel-matched Zoom Aspiration Catheters, the Zoom Pump, the Zoom POD, and other accessories. All Zoom catheters are designed with the TRX Tip which provides a 15% greater clot engagement area at the tip of the catheter.

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“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 chief operating officer at Imperative Care, said in a statement. “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."

At the 2022 World Federation of Interventional and Therapeutic Neuroradiology annual meeting, findings from an independent, single-center study highlighted the safety and efficacy of the Zoom Stroke Solution in patients with middle cerebral artery occlusions. In a 41-patient cohort, 92.7% and 63.4% of patients achieved 2b/3 reperfusion and 2c/3 reperfusion, respectively, based on the thrombolysis in cerebral infarction scale. From arrival to discharge, median scores on National Institutes of Health Stroke Scale significantly decreased from 10.5 (IQR, 7.0-14.5) to 1.5 (IQR, 0.0-6.0; P <.001).2

The stroke system demonstrated safety as well, with no documented perforations or other reperfusion catheter-related complications. Notably, there was one instance (2.4%) of symptomatic intracranial hemorrhage in the study cohort. Overall, the median time from access to first aspiration attempt was 10 minutes (IQR, 6.6-16.5) and median time from access to final reperfusion was 21.5 minutes (IQR, 16.0-31.8).

"We are in a new era of stroke thrombectomy, and Zoom RDL is an important part of this evolution that will allow physicians to get closer to the treatment site for quicker, more efficient stroke procedures without compromising device selection," Davis added.1

REFERENCES
1. Imperative Care announces FDA clearance and initial cases of Zoom RDL, the first stroke-specific radial access platform for mechanical thrombectomy. News release. Imperative Care. January 4, 2022. Accessed January 4, 2022. https://www.businesswire.com/news/home/20230104005059/en/
2. Imperative Care announces positive new data underscoring the safety and efficacy of the Zoom Stroke Solution to treat distal occlusions in ischemic stroke patients. News release. Imperative Care. August 24, 2022. Accessed January 4, 2022. https://www.businesswire.com/news/home/20220824005294/en/Imperative-Care-Announces-Positive-New-Data-Underscoring-the-Safety-and-Efficacy-of-the-Zoom-Stroke-Solution-to-Treat-Distal-Occlusions-in-Ischemic-Stroke-Patients
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