Imperative Care Announces FDA Clearance of Zoom 88 Support, Designed to Bring the Benefits of Intracranial Access to More Stroke Patients
First Patients Treated with Zoom 88 Support at Several Leading Stroke Centers Across the U.S.
CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, a medical technology company developing connected innovations to elevate care for people affected by stroke and other ischemic diseases, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Zoom™ 88 Large Distal Platform (LDP) Support, a portfolio expansion of the company’s Zoom 88 Large Distal Platform.
Imperative Care has pioneered the use of large-bore .088” intracranial access paired with angled-tip aspiration catheters to enable better and faster reperfusion for stroke procedures.1,2 Zoom 88 Support expands the company’s .088” intracranial access portfolio – the only access portfolio on the market to enable large-bore intracranial access. The portfolio also includes the existing Zoom 88 LDP and the Zoom RDL Access Platform. Additionally, the Zoom Stroke Solution™ includes four vessel-matching Zoom Aspiration Catheters with a unique angled tip for enhanced clot ingestion, and the powerful Zoom Pump with Zoom POD for sterile-field clot capture.
Zoom 88 Support features a new engineered support profile designed to maintain the capability of .088” intracranial access with added stability, giving physicians even more control over their thrombectomy procedures in a greater patient population.
“Zoom 88 Support was purposefully designed to meet the needs of more patients and deliver on the feedback we’ve received from physicians. 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,” said Ariel Sutton, GM of Imperative Care’s Stroke business. “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 company also announced the successful completion of initial cases using Zoom 88 Support. One of the first cases was performed by Dr. Harris Hawk, M.D., Interventional Neuroradiologist at Erlanger Health System in Chattanooga, Tenn. Zoom 88 Support was used during treatment of an acute stroke in a patient with a tandem occlusion that required intracranial access with improved proximal support. In the case, Zoom 88 Support provided .088” intracranial access from the femoral artery, allowing the physician to treat the distal occlusion using a Zoom Aspiration Catheter, in addition to providing a stable platform for treatment of the proximal occlusion, resulting in complete TICI 3 revascularization. The patient arrived at the hospital with a debilitating National Institute of Health Stroke Scale (NIHSS) score of 20 and returned to a baseline score of 0 the day 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,” said Dr. Hawk. “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.”
About the Zoom Stroke Solution
The Zoom Stroke Solution is the complete stroke system from access through reperfusion for fast and effective clot removal for patients with acute ischemic stroke. The system includes the Zoom 88 Large Distal Platform and Zoom RDL Radial Access Platform for neurovascular access, four vessel-matched Zoom Aspiration Catheters, the Zoom Pump, the Zoom POD and accessories. All Zoom catheters are designed with the TRX™ Tip which provides 15% greater clot engagement area at the tip of the catheter2 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 has four businesses 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. Milburn J, Vidal G, Gulotta P, et al. E-240 Intracranial large bore guide catheter placement is associated with excellent reperfusion; a single institution experience Journal of NeuroInterventional Surgery 2022;14:A210
2. 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.
Dr. Harris Hawk is a paid consultant of Imperative Care.
Contacts
Investor Contact:
Matt Garrett, CFO
Imperative Care, Inc.
408-476-1672
mgarrett@imperativecare.com
Media Contact:
Lara Lingenbrink
Imperative Care, Inc.
858-525-1414
llingenbrink@imperativecare.com
