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Imperative Care Announces FDA Clearance and Initial Cases of the Zoom 6F Insert Catheters, the First Insert Catheters Built for Stroke

By: via Business Wire

- New technology offered in three unique shapes expands the company’s comprehensive stroke system, allowing physicians to achieve fast and consistent intracranial access

Imperative Care, Inc., today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Zoom™ 6F Insert Catheters, the company’s latest innovation in elevating stroke care and the first insert catheters developed specifically for ischemic stroke procedures. The company also announced the successful completion of the first case with the Zoom 6F Insert Catheters, which was performed by Dr. Dana Tomalty at Huntsville Hospital in Huntsville, Alabama.

Based on physician feedback, the new Zoom 6F Insert Catheters were developed to be more supportive, more torque-able and longer than current vessel selection devices and are offered in three stroke-specific shapes. These features are designed for faster vessel selection and uncompromised delivery of the company’s comprehensive 0.088” intracranial access technologies – Zoom 88, Zoom 88 Support and Zoom RDL – to the intracranial anatomy.

“Insert catheters used for stroke today are diagnostic catheters that were designed for cardiovascular access more than 30 years ago. The Zoom 6F Insert Catheters bring physicians the modern-day tools and technologies that will allow them the opportunity to best care for their patients, bridging the innovation gap of 30 years to today’s standards for stroke treatment,” said Ariel Sutton, General Manager of Imperative Care’s Stroke Business.

“We are deeply committed to working closely with physicians to identify critical gaps in stroke care and providing innovative solutions that bring meaningful benefits to their patients. The introduction of the Zoom 6F Insert Catheters demonstrates our core tenet of clinical partnership, which puts the perspectives of front-line physicians at the center of our research and development process,” added Sutton.

The Zoom 6F Insert Catheter portfolio consists of the Zoom SIM, Zoom VRT, and Zoom VTK technologies – all unique in their shape, construction and length with the goal of helping physicians achieve faster and more reliable intracranial access in a wide range of patient anatomies.

In the first case performed by Dr. Tomalty, the Zoom SIM Insert Catheter was used to quickly select the target vessel and provide .088” intracranial access from the femoral artery with Zoom 88 in a patient with a challenging anatomy and distal left M2 occlusion. The Zoom SIM provided added stability to navigate Zoom 88 far into the brain and access the clot more quickly. Dr. Tomalty then used both Zoom 71 and Zoom 35 to aspirate and remove the clot in only 10 minutes from puncture to reperfusion, resulting in a complete TICI 3 revascularization.

“In my experience, navigating the aortic arch can pose a significant challenge in patients with more tortuous anatomy. Due to the unique design and capabilities of the Zoom 6F Insert Catheters, I believe the use of these technologies will help mitigate this challenge and take minutes off my stroke thrombectomy times, allowing me to get the clot out faster,” Tomalty said.

Clinical evidence shows that the Zoom Stroke Solution can help physicians achieve better reperfusion and faster cases with fewer devices in stroke procedures1,2. Imperative Care is the first company to offer a comprehensive portfolio designed for physicians to rapidly achieve intracranial access from the puncture site to quickly reach the target location and diagnose the clot location, allowing the physician to deliver the ideal aspiration thrombectomy catheter to completely remove the clot. This allows the physician to achieve fast and effective reperfusion for the best possible outcome for the patient.

About the Zoom Stroke Solution

The Zoom Stroke Solution is the complete stroke system from access through reperfusion for fast and effective clot removal in patients presenting with acute ischemic stroke. The system includes a comprehensive access portfolio consisting of the Zoom 6F Insert Catheters, Zoom 88 and Zoom 88 Support Large Distal Platform, Zoom RDL Radial Access Platform, four vessel-matched Zoom Aspiration Catheters, Zoom Pump, Zoom POD and accessories. All Zoom Aspiration Catheters are designed with the unique TRX™ Tip, which provides 15% greater clot engagement area at the tip of the catheter3 and are designed to enable smooth tracking through challenging vasculature. For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: http://bit.ly/2Vx0Qcf

About Imperative Care, Inc.

Imperative Care is a commercial-stage medical technology company researching and developing connected innovations to elevate care for people affected by devastating vascular diseases such as stroke and pulmonary embolism. The company is focused on addressing specific gaps in treatment and care to make an impact across the entire patient journey. Imperative Care is based in Campbell, Calif. https://imperativecare.com.

1. Al-Kawaz M, Milburn J, Tomalty D, et al Higher intracranial positioning of 8fr-guide catheter improves efficacy of aspiration thrombectomy in large vessel occlusion stroke Journal of NeuroInterventional Surgery 2023;15:A131.

2. Milburn J, Vidal G, Gulotta P, et al Intracranial large bore guide catheter placement is associated with excellent reperfusion: a single institution experience Journal of NeuroInterventional Surgery 2022;14:A210.

3. Vargas J, Blalock J, Venkatraman A, et al Efficacy of beveled tip aspiration catheter in mechanical thrombectomy for acute ischemic stroke Journal of NeuroInterventional Surgery 2021;13:823-826.

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