Application of PPODA-QT for embolization of aneurysms

脑动脉瘤是一种不正常的扩大或袋，形成自 大脑中的血管节段变弱通常不被注意和治疗， 动脉瘤可引起突然和灾难性出血或中风。约 15%的患者甚至在接受医疗护理之前就死于动脉瘤破裂 25%的患者在接受治疗后死亡。存活下来的患者通常会遭受 不同程度的发病率。因此，只有四分之一的破裂患者 动脉瘤会完全恢复据估计， 美国人患有脑动脉瘤，美国大约有20，000人 各州每年都有大出血。 虽然最近在提供微创治疗方面取得了显著进展， 使用先进的微导管系统进入动脉瘤， 同样高性能的栓塞材料可以通过这些 导管，以有效地治疗临床上具有挑战性的病变。这次冒险的目的是 为血管内治疗提供创新的生物材料（PPODA-QT）， 动脉瘤，以显著提高治疗效果，同时最大限度地减少 手术风险。 这个第一阶段的提案将开发技术来测试PPODA-QT的可视化 在注射过程中，其机械稳定性和抗颗粒化性， 下游迁移。该项目的主要目标是描述和 优化PPODA-QT，以提交给FDA申请试验用器械豁免 (IDE)批准 初步研究表明，PPODA-QT可以配制并递送至 有效地闭塞长期动物动脉瘤模型，同时还促进 生物活性的愈合反应，可以永久稳定动脉瘤。我们的目标是 开始验证这些初步PPODA-QT结果， FDA制定的程序，以促进新的液体栓塞剂的安全性和有效性， 装置. SBIR第一阶段申请中拟议研究的结果， 结合我们先前发表的研究结果，将有助于启动前， PPODA-QT用于动脉瘤血管内栓塞的临床评估。

A cerebral aneurysm is an abnormal enlargement or pouch that forms from a weakened vessel segment in the brain. Often going unnoticed and untreated, an aneurysm can cause a sudden and catastrophic hemorrhage or stroke. Approximately 15 % of patients die from an aneurysm rupture even before receiving medical attention and 25 % of patients die despite medical treatment. Patients that survive typically suffer from various levels of morbidity. Thus, only one in four patients who suffer a ruptured aneurysm will fully recover. It is estimated that between 3 million and 6 million Americans have cerebral aneurysms, and approximately 20,000 people in the United States suffer hemorrhage each year. While there have been notable recent advances in providing minimally invasive access to aneurysms using advanced micro-catheter systems, there is a paucity of equally high performing embolization materials that can be delivered through these catheters to effectively treat clinically challenging lesions. The purpose of this venture is to provide an innovative biomaterial (PPODA-QT) for the endovascular treatment of aneurysms in order to significantly increase therapeutic effectiveness while minimizing surgical risks. This Phase I proposal will develop techniques to test PPODA-QT’s visualization during injection and its mechanical stability and resistance to particulation and downstream migration. The primary objective of this project is to characterize and optimize PPODA-QT for submission to the FDA for Investigational Device Exemption (IDE) approval. Preliminary studies have shown that PPODA-QT can be formulated and delivered to effectively occlude long-term animal aneurysm models while also promoting a positive bioactive healing response that may permanently stablize the aneurysm. Our goal is to begin validation of these preliminary PPODA-QT results by following the comprehensive procedures laid-out by the FDA to promote safety and efficacy from new liquid embolic devices. The outcomes of the proposed investigations in this SBIR Phase I application, combined with our previously published research results, will help jump-start the pre- clinical assessment of PPODA-QT for endovascular embolization of aneurysms.