Imperative’s Complete Stroke Solution Expands With FDA-Cleared Large Distal Platform

Ariel Sutton

The FDA has granted 510(k) clearance to Imperative Care’s Zoom 88 Large Distal Platform (LDP) Support, a catheter-based approach to improving reperfusion in poststroke patients, further expanding the company’s complete stroke system.¹

Zoom 88 Support is a part of the company’s Zoom Stroke Solution, which includes the existing Zoom 88 LDP and the Zoom RDL Access Platform, as well as Zoom Aspiration Catheters and Zoom POD and Pump. The newly added feature is designed to maintain the capability of 0.88” intracranial access with added stability, giving clinicians even more control over their thrombectomy procedures.

"Zoom 88 Support was purposefully designed to meet the needs of more patients and deliver on the feedback we’ve received from physicians,” Ariel Sutton, general manager of Imperative Care’s Stroke business, said in a statement.¹ "Zoom 88 Support provides the same benefits of intracranial access found with Zoom 88 LDP, with the ability to treat more proximal or tandem occlusions. With the introduction of Zoom 88 Support, we continue to grow our patient-first portfolio to bring the benefits of large-bore intracranial access to more people."

The Zoom Stroke Solution is comprised of 4 vessel-matching Zoom Aspiration Catheters with a unique angled tip for enhanced clot ingestion, and the Zoom Pump with Zoom POD for sterile-field clot capture. All Zoom catheters are designed with the TRX Tip, which provides 15% greater clot engagement area at the tip of the catheter and are designed to enable smooth tracking through challenging vasculature.

Imperative Care also announced the first successful completion of initial cares using Zoom 88 Support. In one specific case, a patient with a tandem occlusion, use of Zoom 88 Support provided .088” intracranial access from the femoral artery, allowing the physician to treat the distal occlusion using a Zoom Aspiration Catheter, resulting in complete thrombolysis in cerebral infarction scale score 3 revascularization. Performed by Harris Hawk, MD, interventional neuroradiologist, Erlanger Health System, the patient’s National Institute of Health Stroke Scale score was reduced from 20 to 0 following treatment.

"Zoom 88 Support provides me with a new capability for achieving intracranial access to treat a broader population of stroke patients, enabling the best possible outcome based on each patient’s anatomy," Hawk said in a statement.1 "With products like Zoom 88 Support, Imperative Care continues to respond to the needs of patients with much-needed solutions to help streamline stroke procedures and treat patients quickly and effectively."

READ MORE: High-Definition Cathodal Direct Current Stimulation Shows Potential as Noninvasive Treatment for Ischemic Stroke

Earlier this year, in January, the FDA gave clearance to Imperative’s Zoom RDL Access System, making it the first radial access platform developed specifically for treating patients with ischemic stroke. Zoom RDL features an extended hydrophilic coating and the longest optimized vessel dilator on the market. In the first in-human operation using Zoom RDL, the system was successful, providing .088 inches of intracranial access from the radial artery, with complete revascularization achieved in less than 20 minutes.²

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).³

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).

REFERENCES
1. Imperative Care announces FDA clearance of Zoom 88 Support, designed to bring the benefits of intracranial access to more stroke patients. News release. July 25, 2023. Accessed July 25, 2023. https://www.biospace.com/article/releases/imperative-care-announces-fda-clearance-of-zoom-88-support-designed-to-bring-the-benefits-of-intracranial-access-to-more-stroke-patients/
2. 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 July 25, 2022. https://www.businesswire.com/news/home/20230104005059/en/
3. 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 July 25, 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