Development of an Innovative Material for Transcatheter Peripheral Embolization

经导管外周栓塞创新材料的开发

基本信息

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
项目类别：
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

项目摘要

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.

项目概要出血和不受控制的出血是死亡的主要原因，如果不致命，可能会导致不良后果具有长期负面后果的健康结果，包括器官损伤或衰竭以及昏迷。不受控制的出血可能由多种疾病、外伤和健康状况引起，例如心房颤动，在美国有超过 260 万人受其困扰。大多数房颤患者都需要服用抗凝剂（ACAs）。内出血的护理标准 (SOC) 是经导管栓塞然而，为了闭塞动脉或静脉出血，目前可用的方法存在重大缺陷，包括成本高、缺乏完全闭塞、依赖患者凝血、难以正确给药、成像伪影以及材料迁移或碎片的可能性。有一个显着的未解需要与 ACA 兼容、易于使用、有效且安全的栓塞材料使用。为了满足这一需求，在这份快速提案中，Obsidio, Inc 正在开发一种创新的栓塞剂称为剪切稀化生物材料 (STB) 的材料，具有多功能和有效的栓塞物质。 STB 即用型，无需混合或准备，易于管理通过标准微导管，可以在短期或较长时间内输送，而不必担心堵塞导管，给药后不会产生图像伪影，并且由安全且可靠的材料组成生物相容性。此外，STB 对于患者和医院来说都是一种更具成本效益的选择，并且不需要与其他方法相同水平的专业知识来管理。此快速通道提案的目标是开发用于控制外周出血的临床级 STB 制剂并启动设计冷冻，通过离体和体内研究证明生物材料和设备的安全性，并完成FDA要求的测试，包括生物相容性研究和GLP动物研究。在快速通道的第一阶段，我们建议最终确定 STB 配方，验证临床- 对 STB 进行分级，并评估其在非 GLP 啮齿动物模型中的性能。在快速通道的第二阶段，我们建议验证 STB 在非 GLP 猪出血模型中的性能，然后采用 ISO-10993 生物相容性研究以确认生物材料的安全性，包括体外体内相关性研究确定 STB 的降级。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 Obsidio 提升到 510k 用于外周出血的 STB 清除。总体而言，这种新型生物材料的开发将提供为医生提供了一种新颖的栓塞选择，具有卓越的性能和多功能性，最终将有助于挽救生命每年有数十万人丧生。