TG Medical’s TG Dilator Approval Study Completes Enrollment in Japan

May 9, 2025—TG Medical recently announced the completion of patient enrollment in its approval study for the TG dilator, which is designed to treat intracranial atherosclerotic disease (ICAD) presenting with acute ischemic stroke caused by large vessel occlusion.

The Tokyo, Japan–based company stated that the multicenter study, which reached full enrollment ahead of schedule, is being conducted across leading stroke centers in Japan to pursue regulatory approval. TG Medical advised that it plans to submit the results to Japanese regulatory authorities after final data collection and analysis. Nobuyuki Sakai, MD, is the principal investigator of the trial.

“Acute ischemic strokes caused by intracranial atherosclerosis remain a significant treatment challenge,” commented Dr. Sakai in the company’s press release. “The TG dilator represents a promising solution to improve recanalization success and patient outcomes in this difficult-to-treat population.”

Additionally, TG Medical stated that results from the first-in-human (FIH) trial of the TG dilator were published by Tsuyoshi Ohta, MD, et al in the Journal of NeuroInterventional Surgery. According to the company, all 10 patients in the FIH trial achieved significant recanalization without any device-related adverse events, and 80% of patients attained favorable functional outcomes at 90 days. The trial demonstrated the TG dilator’s safety and potential efficacy in treating ICAD-related acute ischemic strokes, stated TG Medical.