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Article

Postmarketing Surveillance of Thrombectomy Using a Tron FX Stent Retriever for Large and Medium Vessel Occlusion

by
Hirotoshi Imamura
1,2,*,
Nobuyuki Sakai
2,3,
Masataka Takeuchi
4,
Tsuyoshi Ohta
2,5,
Nobuyuki Ohara
6,
Yukako Yazawa
7,
Yoshinori Akiyama
8,
Maki Fukuda
9,
Keisuke Imai
10,
Chiaki Sakai
2,11,
Yasushi Matsumoto
12,
Yuji Matsumaru
13,
Hiroshi Yamagami
13,14,
Shinichi Yoshimura
15,
Yasushi Ito
16,
Naoya Kuwayama
17 and
Tatsuo Kagimura
18
1
Department of Neurosurgery, National Cerebral and Cardiovascular Center, Suita 564-8565, Japan
2
Department of Neurovascular Research, Kobe City Medical Center General Hospital, Kobe 650-0047, Japan
3
Department of Neurosurgery, Seijinkai Shimizu Hospital, Kyoto 615-8237, Japan
4
Department of Neurosurgery, Seisho Hospital, Odawara 250-0001, Japan
5
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe 650-0047, Japan
6
Department of Neurology, Kobe City Medical Center General Hospital, Kobe 650-0047, Japan
7
Department of Stroke Neurology, Kohnan Hospital, Sendai 982-8523, Japan
8
Department of Neurosurgery, Tenri Hospital, Tenri 632-8552, Japan
9
Department of Neurosurgery, Kochi Health Sciences Center, Kochi 781-0111, Japan
10
Department of Neurology and Stroke Treatment, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto 605-0981, Japan
11
Department of Regulatory Science of Medical Device Development and Innovation, Kyoto University Graduate School of Medicine, Kyoto 606-8303, Japan
12
Division of Development and Discovery of Interventional Therapy, Tohoku University Hospital, Sendai 980-8574, Japan
13
Department of Neurosurgery, Institute of Medicine, University of Tsukuba, Tsukuba 305-8575, Japan
14
Department of Stroke Neurology, National Hospital Organization, Osaka National Hospital, Osaka 540-0006, Japan
15
Department of Neurosurgery, Hyogo Medical University, Nishinomiya 663-8501, Japan
16
Department of Neurosurgery, Shinrakuen Hospital, Niigata 950-2038, Japan
17
Department of Neurosurgery, Japanese Red Cross Toyama Hospital, Toyama 930-0859, Japan
18
Foundation for Biomedical Research and Innovation at Kobe, Translational Research Center for Medical Innovation, Kobe 650-0047, Japan
 
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Author to whom correspondence should be addressed.
J. Clin. Med. 2025, 14(22), 7913; https://doi.org/10.3390/jcm14227913 (registering DOI)
Submission received: 2 September 2025 / Revised: 16 October 2025 / Accepted: 18 October 2025 / Published: 7 November 2025
(This article belongs to the Special Issue Current Situation and Challenges of Endovascular Treatment Strategies for Acute Ischemic Stroke)
Versions Notes

Abstract

Background/Objectives: The Tron FX is a stent retriever thrombectomy device that underwent a clinical trial in Japan in 2016. Its key feature is the availability of a 2/15 mm model designed for medium-vessel occlusion (MeVO). This study reports the results of postmarketing surveillance (PMS) conducted from 2019 to 2020. Methods: The PMS included data from 240 patients in whom a Tron FX was used during the first pass at 24 Japanese institutions. Occluded vessels involving the M2 and M3 segments of the middle cerebral artery, anterior cerebral artery, and posterior cerebral artery were classified as MeVO. The recanalization rate, first pass effect (FPE) rate, symptomatic intracranial hemorrhage (sICH) rate, and favorable prognosis rate at 90 days were evaluated. Treatment outcomes were also analyzed for cases in which the device was used after the second pass, excluding those with tandem occlusion, atherothrombotic brain infarction (ATBI), or percutaneous transluminal angioplasty (evaluation-appropriate cases), stratified by MeVO and large vessel occlusion (LVO) and according to Tron FX device size. Results: A total of 244 cases were enrolled, of which 218 were evaluation-appropriate. Across all cases, the recanalization rate (modified Thrombolysis in Cerebral Infarction score ≥ 2b) was 70.9%, the FPE rate was 23.4%, the sICH rate was 3.8%, and the proportion of patients with a good prognosis (modified Rankin Scale score 0–2 at 90 days) was 53.1%. Among evaluation-appropriate cases, excluding those with tandem lesions or ATBI, the corresponding rates were 72.9%, 24.8%, 6.9%, and 45.5%, respectively. When analyzed by occluded vessel type, the rates for MeVO were 71.9%, 23.7%, 6.1%, and 45.7%, respectively, while those for LVO were 74.0%, 26.0%, 7.7%, and 45.1%. According to device size, the outcomes for the 2/15 mm Tron FX were 72.9%, 23.5%, 4.7%, and 50.0%, respectively, and those for the 4/20 mm device were 72.9%, 25.6%, 8.3%, and 42.5%. Conclusions: The PMS results for the Tron FX thrombectomy device were excellent, particularly for MeVO and the 2/15 mm model. These findings suggest that the Tron FX may help improve thrombectomy outcomes in MeVO.
Keywords: Tron FX stent retriever; medium vessel occlusion; mechanical thrombectomy; postmarketing surveillance Tron FX stent retriever; medium vessel occlusion; mechanical thrombectomy; postmarketing surveillance

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MDPI and ACS Style

Imamura, H.; Sakai, N.; Takeuchi, M.; Ohta, T.; Ohara, N.; Yazawa, Y.; Akiyama, Y.; Fukuda, M.; Imai, K.; Sakai, C.; et al. Postmarketing Surveillance of Thrombectomy Using a Tron FX Stent Retriever for Large and Medium Vessel Occlusion. J. Clin. Med. 2025, 14, 7913. https://doi.org/10.3390/jcm14227913

AMA Style

Imamura H, Sakai N, Takeuchi M, Ohta T, Ohara N, Yazawa Y, Akiyama Y, Fukuda M, Imai K, Sakai C, et al. Postmarketing Surveillance of Thrombectomy Using a Tron FX Stent Retriever for Large and Medium Vessel Occlusion. Journal of Clinical Medicine. 2025; 14(22):7913. https://doi.org/10.3390/jcm14227913

Chicago/Turabian Style

Imamura, Hirotoshi, Nobuyuki Sakai, Masataka Takeuchi, Tsuyoshi Ohta, Nobuyuki Ohara, Yukako Yazawa, Yoshinori Akiyama, Maki Fukuda, Keisuke Imai, Chiaki Sakai, and et al. 2025. "Postmarketing Surveillance of Thrombectomy Using a Tron FX Stent Retriever for Large and Medium Vessel Occlusion" Journal of Clinical Medicine 14, no. 22: 7913. https://doi.org/10.3390/jcm14227913

APA Style

Imamura, H., Sakai, N., Takeuchi, M., Ohta, T., Ohara, N., Yazawa, Y., Akiyama, Y., Fukuda, M., Imai, K., Sakai, C., Matsumoto, Y., Matsumaru, Y., Yamagami, H., Yoshimura, S., Ito, Y., Kuwayama, N., & Kagimura, T. (2025). Postmarketing Surveillance of Thrombectomy Using a Tron FX Stent Retriever for Large and Medium Vessel Occlusion. Journal of Clinical Medicine, 14(22), 7913. https://doi.org/10.3390/jcm14227913

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