Development of an Innovative Material for Transcatheter Peripheral Embolization

经导管外周栓塞创新材料的开发

• 批准号: 10513904
• 负责人: Ehsan Jabbarzadeh
• 金额: $ 124.78万
• 依托单位: OBSIDIO, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10513904
• 关键词: Acute; Address; Advanced Development; Adverse effects; Angiography; Animals; Anti-Inflammatory Agents; Anticoagulants; Arteries; Atrial Fibrillation; Biocompatible Materials; Biodistribution; Blood Tests; Blood Vessels; Catheters; Cause of Death; Chronic; Clinical; Coagulation Process; Coma; Contrast Media; Correlation Studies; Data; Development; Devices; Disease; Effectiveness; Ensure; Failure; Formulation; Freedom; Freezing; Fright; Gelatin; Guidelines; Health; Health Care Costs; Heart; Hemorrhage; Hemostatic Agents; Hepatic artery; Hindlimb; Histology; Hospitals; Hydrogels; Image; Immune response; Immunologics; Implant; In Vitro; Injectable; Intellectual Property; Interview; Kidney; Lead; Legal patent; Life; Liquid substance; Measures; Mechanics; Methods; Modeling; Morphologic artifacts; Organ; Outcome; Patient risk; Patients; Pelvis; Performance; Peripheral; Persons; Phase; Physiological; Preparation; Procedures; Property; Research Design; Risk; Rodent; Rodent Model; Roentgen Rays; Safety; Silicates; Sterility; Sterilization; Structure of splenic artery; Testing; Therapeutic Embolization; Thinness; Thrombus; Time; Toxic effect; Toxicology; Traumatic injury; Treatment Failure; Ultrasonography; United States; Veins; Work; X-Ray Computed Tomography; base; biomaterial compatibility; carcinogenicity; clinical development; clinical efficacy; cost; cost effective; crosslink; cytokine; cytotoxicity; design; femoral artery; genotoxicity; hemocompatibility; high risk; implantation; in vivo; in vivo Model; innovation; irritation; malformation; meetings; migration; minimally invasive; neurovascular; novel; off-label use; phase 1 designs; porcine model; radiologist; response; standard of care; success; usability

PROJECT SUMMARY Hemorrhage and uncontrolled bleeding are a leading cause of death, and when not fatal can result in adverse health outcomes with long term negative consequences including organ damage or failure, and coma. Uncontrolled bleeding can arise from a variety of diseases, traumatic injuries, and health conditions, such as atrial fibrillation, which afflicts over 2.6M people in the United States. Most atrial fibrillation patients are required to take anticoagulants (ACAs). The standard of care (SOC) for internal hemorrhage is transcatheter embolization to occlude the bleeding artery or vein, however, there are major drawbacks of currently available methods, including high cost, lack of complete occlusion, reliance on patient coagulation, difficultly of proper administration, imaging artifacts, and the chance of migration or fragmentation of the material. There is a significant unment need for embolization materials that are compatible with ACAs, are easy to use, and are effective and safe for use. To address this need, in this Fast-track proposal Obsidio, Inc is developing an innovative embolic material called shear-thinning biomatieral (STB) that has the qualities required for a versatile and effective embolic material. STB is ready to use and does not require mixing or preparation, is easy to administer via standard microcatheters, can be delivered over a short or extended time period without fear of clogging the catheter, does not produce an image artifact after administration, and is comprised of materials that are safe and biocompatible. Moreover, STB is a more cost-effective option for both patients and hospitals and does not require the same level of expertise to administer as other methods.The objective of this Fast-track proposal is to develop a clinical-grade formulation of STB for peripheral hemorrhage control and initate a design freeze, demonstrate safety of both the biomaterial and the device through ex vivo and in vivo studies, and complete the testing required by the FDA including biocompatibility studies and GLP animal studies. In Phase I of the Fast-track we propose to finalize STB formulation, validate the safety and efficacy of clinical- grade STB, and evaluate its performance in a non-GLP rodent model. In Phase II of the Fast-track we propose to validate STB performance in a non-GLP bleeding porcine model of hemorrhage, followed by ISO-10993 biocompatbility studies to confirm safety of the biomateirals, including an in vitro in vivo correlation studies to determine the degradation of STB. Finally, we will conduct GLP studies in a porcine model to characterize the performance and safety of STB. Successful completion of this work with enable Obsidio to advance to 510k clearance for STB used in peripheral hemorrhage. Overall, development of this novel biomaterial will provide physcians a novel embolization option with superior performance and versatility that will ultimately help to save hundreds of thousands of lives annually.

项目摘要 出血和不受控制的出血是死亡的主要原因，而没有致命的情况会导致不良 长期负面后果的健康结果，包括器官损伤或失败以及昏迷。 不受控制的出血可能来自多种疾病，创伤性伤害和健康状况，例如 心房颤动，在美国遭受了260万人的困扰。大多数房颤患者需要 服用抗凝剂（ACA）。内部出血的护理标准（SOC）是经导管栓塞 但是，为了阻塞出血或静脉，当前可用的方法存在主要缺点， 包括高成本，缺乏完全阻塞，依赖患者凝血，难以适当给药， 成像伪像，以及材料迁移或破碎的机会。有一个重要的一体 需要与ACA兼容的栓塞材料，易于使用，并且有效且安全。 使用。为了满足这一需求，在这个快速提议的Opsidio中，Inc正在开发创新的栓塞 材料称为剪切稀有生物毛（STB），具有多功能和 有效的栓塞材料。 STB已准备就绪，不需要混合或准备，易于管理 通过标准的微心会员可以在短时或延长的时间内交付 导管在给药后不会产生图像伪像，并且由安全和 生物相容性。此外，STB对患者和医院都是更具成本效益的选择，不需要 与其他方法相同的专业知识水平。该快速提案的目的是 开发用于外围出血控制的STB的临床级配方并启动设计 冻结，通过体内和体内研究证明生物材料和设备的安全性， 并完成FDA所需的测试，包括生物相容性研究和GLP动物研究。 在快速轨道的第一阶段，我们建议敲定STB公式，验证临床的安全性和功效 等级STB，并在非GLP啮齿动物模型中评估其性能。在快速轨道的第二阶段中，我们提出 在非GLP出血模型中验证STB性能，然后是ISO-10993 生物相容性研究以确认生物介绍剂的安全性，包括体内相关性研究 确定STB的降解。最后，我们将在猪模型中进行GLP研究，以表征 STB的性能和安全性。成功完成这项工作，使Opsidio能够前进到510k 周围出血中使用的STB清除率。总体而言，这种新型生物材料的发展将提供 医生是一种具有出色性能和多功能性的新颖栓塞选项，最终将有助于保存 每年成千上万的生命。