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E-066 A novel braided stent with customized simulation software for treatment of intracranial aneurysms: multicenter prospective trial before unrestricted clinical application, long-term results
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  1. I Kan1,
  2. H Oishi2,
  3. A Hyodo3,
  4. S Nemoto4,
  5. S Fujimura5,
  6. T Ishibashi1,
  7. K Sumita6,
  8. T Takigawa7,
  9. K Teranishi8,
  10. T Kodama1,
  11. N Kato1,
  12. H Takao1,
  13. Y Murayama1
  1. 1Neurosurgery, The Jikei University School of Medicine, Tokyo, Japan
  2. 2Neuroendovacular Therapy and Neurosurgery, Juntendo University Faculty of Medicine, Tokyo, Japan
  3. 3Neurosurgery, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan
  4. 4Department of Endovascular surgery, Tokyo Medical and Dental University, Tokyo, Japan
  5. 5Department of Mechanical Engineering, Tokyo University of Science, Tokyo, Japan
  6. 6Neurosurgery, Tokyo Medical and Dental University, Tokyo, Japan
  7. 7Neurosurgery, Dokkyo Medical University Saitama Medical Center, Saitama, Japan
  8. 8Neurosurgery, Juntendo University Faculty of Medicine, Tokyo, Japan

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.

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