Clinical trial for development of a steerable microcatheter

Abstract

Purpose: A steerable microcatheter provided with a mechanism on the handle for changing the direction of the catheter tip was developed by Sumitomo Bakelite and evaluated in a clinical trial before introduction into clinical use.

Material and methods: The steerable microcatheter has a 2.4F/2.9-F external diameter (distal/proximal portion) and a 0.021-inch internal diameter with a dial on the proximal portion for moving the tip. In patients scheduled to undergo selective transarterial procedures, selective arteriography of target arterial branches chosen by the evaluator was performed using the steerable microcatheter during the procedure. Efficacy was evaluated based on operability (technical success, procedure time, use of guidewire, usefulness of tip mobility), and safety was evaluated based on defects and adverse events.

Results: Between September 2013 and October 2013, 20 patients were enrolled at four institutions. The success rate for guidewireless insertion of the steerable microcatheter into the target vessels was 96.7%, and operability was judged as good in all 20 patients. Poor tip movement was identified as a defect of the steerable microcatheter in one patient. There were no adverse events associated with the use of the steerable microcatheter.

Conclusion: This trial confirmed that the steerable microcatheter had the utility required for medical device approval. Thereafter, it obtained marketing approval.

Keywords:

• Steerable microcatheter
• selective angiography
• clinical trial

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Additional information

Funding

All authors declare that they received financial assistance from Sumitomo Bakelite Co., Ltd. in this study.