Yoshitaka Inaba1, Yasuaki Arai2, Miyuki Sone2, Takeshi Aramaki3, Keigo Osuga4, Hayao Tanaka5, Kenichi Kanemasa5. 1. a Department of Diagnostic and Interventional Radiology , Aichi Cancer Center Hospital , Aichi , Japan. 2. b Department of Diagnostic Radiology , National Cancer Center Hospital , Tokyo , Japan. 3. c Division of Interventional Radiology , Shizuoka Cancer Center , Sizuoka , Japan. 4. d Department of Diagnostic and Interventional Radiology , Osaka University Graduate School of Medicine , Osaka , Japan. 5. e Sumitomo Bakelite Co., Ltd , Tokyo , Japan.
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.
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.
Authors: Zbigniew Serafin; Olivier Dudeck; Maciej Powerski; Florian Wolf; Ralph Drewes; Maciej Pech Journal: Wideochir Inne Tech Maloinwazyjne Date: 2020-01-21 Impact factor: 1.195