Imperative Care Announces NVQI Registry Data on the Real-World Performance of the Zoom Aspiration Catheters for Ischemic Stroke Treatment

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The primary goals of the NVQI-QOD registry are to provide a platform for driving improvement in stroke care while meeting the demands set by regulatory agencies and evaluating the safety and clinical performance of medical devices used in treatment of acute ischemic stroke.

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Wednesday, August 2, 2023
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Surgery, Medical Devices, Health, Clinical Trials, Cardiology, Neuroradiology, Northwestern Medicine, Society, Stroke, Imperative, Thrombectomy, PSO, The Society of Neurological Surgeons, AANS, American Association of Neurological Surgeons, Patient, Annual general meeting, Reperfusion, ICA, FDA, Patient safety organization, M1, Safety, Pharmaceutical industry, Medical device
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UNITED STATES, NORTH AMERICA, CALIFORNIA
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IMPERATIVE CARE, IMPERATIVE CARE, INC.
Summary
Key Points: 
  • The primary goals of the NVQI-QOD registry are to provide a platform for driving improvement in stroke care while meeting the demands set by regulatory agencies and evaluating the safety and clinical performance of medical devices used in treatment of acute ischemic stroke.
  • “We are excited about the opportunity to collaborate with NVQI-QOD to reinforce the safety and effectiveness of our unique angled-tip aspiration catheters for treating patients with ischemic stroke,” said Ariel Sutton, General Manager of Imperative Care’s Stroke business.
  • “Continuing to add to our growing body of evidence with the Zoom Stroke Solution is a priority for Imperative Care.
  • “These real-world data demonstrate that treatment with the Zoom Aspiration Catheters led to high rates of successful reperfusion in patients with ischemic stroke, with no safety concerns.


Imperative Care, a medical technology company developing connected innovations to elevate care for people affected by stroke and other ischemic diseases, today announced that late-breaking data from the Neurovascular Quality Initiative-Quality Outcome Database (NVQI-QOD) evaluating the Zoom Stroke Solution were presented at the Society of NeuroInterventional Surgery (SNIS) 2023 20th Annual Meeting in San Diego, Calif.

The NVQI-QOD is a registry developed by SNIS through its Patient Safety Organization (PSO), along with the NeuroPoint Alliance of the American Association of Neurological Surgeons (AANS) and Society of Vascular and Interventional Neurology (SVIN). The primary goals of the NVQI-QOD registry are to provide a platform for driving improvement in stroke care while meeting the demands set by regulatory agencies and evaluating the safety and clinical performance of medical devices used in treatment of acute ischemic stroke.

“We are excited about the opportunity to collaborate with NVQI-QOD to reinforce the safety and effectiveness of our unique angled-tip aspiration catheters for treating patients with ischemic stroke,” said Ariel Sutton, General Manager of Imperative Care’s Stroke business. “Continuing to add to our growing body of evidence with the Zoom Stroke Solution is a priority for Imperative Care. These data further demonstrate the positive association between the use of the Zoom Aspiration Catheters with procedure times and successful final reperfusion.”

The safety and clinical performance data from 211 patients with large or medium sized vessel occlusions who were treated with Zoom Aspiration Catheters were presented by Mahesh Jayaraman, M.D., Brown University. In 67.8% of patients, an aspiration-first technique was used, and in the remaining 32.2% of patients, a combined technique using aspiration with a stent-retriever was used. Adjunctive therapies including intra- or extra-cranial angioplasty and/or stenting was performed in 9% of patients.

Results from the analysis showed that:

  • Median time from arterial puncture to recanalization was 22 minutes.
  • TICI≥2B reperfusion was achieved in 91.9% of patients, and in 59% of patients after the first pass.
  • Overall, TICI≥2C reperfusion was achieved in 59.2% of patients.
  • When examining by clot location, rates of final TICI≥2C reperfusion were 53.8% for ICA, 58.7% for M1, 57.4% for M2 and 69.2% for medium vessels.
  • Among the patients with 90-day follow-up data, 53.2% were functionally independent with Modified Rankin Scale scores of 0-2.
  • The overall rate of symptomatic intracranial hemorrhage was 2.8%.

“The angled-tip Zoom Aspiration Catheters have become a valuable tool for stroke thrombectomy procedures due to their proven trackability and ability to engage clot effectively,” said Mahesh Jayaraman, M.D., Brown University. “These real-world data demonstrate that treatment with the Zoom Aspiration Catheters led to high rates of successful reperfusion in patients with ischemic stroke, with no safety concerns. We look forward to future NVQI-QOD efforts to analyze valuable real-world data and evaluate the safety and effectiveness of new and promising technologies in the space.”

“The clinical outcomes from this study are inspiring and prove that the NVQI-QOD registry harbors valuable data which can be leveraged by researchers, FDA regulators, payors, and industry to demonstrate innovative medical devices improve patient outcomes,” said Sameer Ansari, M.D., Ph.D., interventional neuroradiologist at Northwestern Medicine and NVQI-QOD SNIS PSO Medical Director.

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 catheter1 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. 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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