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Updated: Feb 11, 2026
09:09
In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
2.3K
Clinical trial for development of a steerable microcatheter
Yoshitaka Inaba1, Yasuaki Arai2, Miyuki Sone2
1a Department of Diagnostic and Interventional Radiology , Aichi Cancer Center Hospital , Aichi , Japan.
Summary
A new steerable microcatheter demonstrated high success rates and excellent operability in a clinical trial. This medical device achieved marketing approval, confirming its utility for transarterial procedures.
Area of Science:
- Medical Devices
- Interventional Radiology
- Catheter Technology
Background:
- Development of advanced catheter systems is crucial for minimally invasive procedures.
- Steerable microcatheters offer enhanced navigation in complex vascular anatomies.
Purpose of the Study:
- To evaluate the clinical utility and safety of a newly developed steerable microcatheter.
- Assess the performance of a microcatheter with a handle-based tip direction mechanism.
Main Methods:
- A clinical trial involving 20 patients undergoing selective transarterial procedures.
- Evaluation of efficacy based on technical success, procedure time, and tip mobility.
- Assessment of safety through monitoring defects and adverse events.
Main Results:
- 96.7% success rate for guidewireless insertion into target vessels.
- Operability was rated as good in all 20 patients.
- No adverse events were reported; one case of poor tip movement was noted.
Conclusions:
- The steerable microcatheter met the utility requirements for medical device approval.
- The device successfully obtained marketing authorization following the trial.
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