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August 2, 2023

Imperative Care’s Zoom Aspiration Catheters Real-World Performance Data Evaluated in NVQI Registry

August 2, 2023— Imperative Care announced findings from the Neurovascular Quality Initiative-Quality Outcome Database (NVQI-QOD) evaluating the company’s Zoom stroke solution.

Imperative Care noted that 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. The NVQI-QOD registry was developed by the Society of NeuroInterventional Surgery (SNIS) through its Patient Safety Organization (PSO), along with the NeuroPoint Alliance of the American Association of Neurological Surgeons and the Society of Vascular and Interventional Neurology.

The late-breaking data were presented by Mahesh Jayaraman, MD, at SNIS 2023, the society’s 20th annual meeting held July 31 to August 4 in San Diego, California. Dr. Jayaraman is with Brown University in Providence, Rhode Island.

According to the company, the presentation included safety and clinical performance data from 211 patients with large- or medium-sized vessel occlusions who were treated with Zoom aspiration catheters.

In 67.8% of patients, an aspiration-first technique was used. In the remaining 32.2% of patients, a combined technique using aspiration with a stent-retriever was used. Adjunctive therapies including intra- or extracranial angioplasty and/or stenting was performed in 9% of patients.

As summarized in the company’s press release, results from the analysis showed the following:

  • Median time from arterial puncture to recanalization was 22 minutes.
  • Thrombolysis in cerebral infarction (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 internal carotid artery (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,” commented Dr. Jayaraman in Imperative Care’s press release. “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.”

Sameer Ansari, MD, who is the NVQI-QOD SNIS PSO Medical Director, and an interventional neuroradiologist at Northwestern Medicine in Chicago, Illinois, added, “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.”

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