A Novel Braided Stent With Customized Simulation Software for Treatment of Intracranial Aneurysms: Multicenter Prospective Trial Before Unrestricted Clinical Application

BACKGROUND AND OBJECTIVES:Planning/guidance software became important tools for physicians' presurgical optimal decision-making. However, there are no intracranial stent products with specifically associated simulation software. We report the "premarket" clinical trial of a new braided stent with a customized simulation software. METHODS:A stent system with 3 mesh density types (16, 24, and 32 wire mesh) was designed based on computational flow dynamics technology, and a simulation software (virtual stent planner [VSP]) was developed for the optimal stent deployment planning. Stents were selected after simulation on preoperative 3D-processed angioimages, and accuracy of the VSP was evaluated. RESULTS:Thirty-three unruptured intracranial aneurysms were successfully treated with VSP guidance. Twenty aneurysms (61%) were anterior circulation aneurysms, and 13 (39%) were posterior circulation aneurysms. The average aneurysm size was 7.1 mm, and the mean follow-up period was 19.2 months (11-39.0). There was no major recurrence or retreatment during follow-up, 2 morbidity cases, and no mortality. VSP planning presented slightly smaller stent dimensions compared with postdeployment: 24.2 vs 25.5 mm average, error -1.3 mm, and difference rate-5.46%. CONCLUSION:Based on this result, the new stents and software guidance system were approved by the Ministry of Health and Welfare as a combined medical device. VSP provided precise deployment with minimal error compared with actual stent and can contribute to better stent deployment even for less experienced physicians.