Article Text
Abstract
Introduction 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 with long term results.
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 42.2 months (14–63). 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 post deployment: 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.
Disclosures I. Kan: 4; C; hold stock share options for PENTAS Inc. H. Oishi: None. A. Hyodo: None. S. Nemoto: None. S. Fujimura: None. T. Ishibashi: None. K. Sumita: None. T. Takigawa: None. K. Teranishi: None. T. Kodama: None. N. Kato: None. H. Takao: None. Y. Murayama: 4; C; hold stock share options for PENTAS Inc.