Preclinical Testing of a Novel Flow Diverting Stent for Treating Intracranial Aneurysms

治疗颅内动脉瘤的新型血流转向支架的临床前测试

• 批准号: 9046467
• 负责人: DAVID F KALLMES
• 金额: $ 107.27万
• 依托单位: NEUROSIGMA, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-15 至 2019-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9046467
• 关键词: Address; Aneurysm; Animal Model; Animals; Arteries; Biocompatible Materials; Biological; Blood; Blood Vessels; Clinic; Coagulation Process; Development; Devices; Feedback; Film; General Population; Generations; Giant Intracranial Aneurysms; Goals; Growth; Head; Healed; Human; Implant; In Vitro; Industry Standard; Intracranial Aneurysm; Marketing; Metals; Methods; Morbidity - disease rate; Neck; Parents; Patients; Performance; Phase; Preclinical Testing; Process; Program Development; Risk; Rupture; Silicon; Small Business Technology Transfer Research; Stents; Tail; Technology; Testing; Time; Tissues; Tubular formation; base; commercialization; density; follow-up; healing; human study; implantation; improved; improved outcome; meetings; minimally invasive; mortality; neurovascular; next generation; nitinol; novel; pre-clinical; prevent; prototype; public health relevance; reconstruction; repaired; scaffold; success; uptake

 DESCRIPTION (provided by applicant): The purpose of this project is to develop an improved, minimally-invasive treatment for intracranial aneurysms. Intracranial aneurysms are spherical outpouchings of blood vessels in the head that result from weakness in the vessel wall. Unruptured aneurysms are present in approximately 3% of the general population, and rupture can be devastating with a high morbidity and mortality. In recent years a new type of minimally- invasive endovascular device to treat aneurysms has been introduced to the market. These devices, known as flow diverting stents, are composed of a tubular metal mesh and are placed in the parent artery to cover the neck of the aneurysm being treated. The small pores in the mesh prevent blood from entering the aneurysm, which causes blood trapped inside the aneurysm to become stagnant and clot. The aneurysm then undergoes a process of healing with the stent acting as a scaffold for reconstruction of the parent artery. Despite their success, first-generation flow diverters suffer from a number of limitations such as delayed aneurysm occlusion, often on the order of months, and the need for multiple devices per patient to achieve complete occlusion. In as many as 25% of patients complete occlusion is never achieved. NeuroSigma's next generation flow diverter is based on Thin Film Nitinol (TFN) technology. TFN is an advanced biomaterial fabricated on silicon wafers that overcomes many of the limitations associated with first-generation flow diverters. Results from animal studies suggest that the TFN flow diverter gives superior rates of aneurysm occlusion and faster parent artery repair than first-generation devices. The purpose of this project is to build upon these intriguing findings an develop a "rapid occlusion" flow diverter, where placement of a single device results in speedy, definitive aneurysm repair. At the completion of this project the TFN flow diverter will be ready t begin first- in-human studies as an improved treatment for the millions who suffer from intracranial aneurysms worldwide.