Radiopaque Shape Memory Polymers for Neurovascular Embolotherapy Applications

不透射线形状记忆聚合物 神经血管栓塞治疗应用 项目总结/摘要 该I期项目涉及神经血管栓塞治疗的重大改进。动脉瘤有助于 显著增加年死亡率：美国估计有650万人（约50分之1）患有未破裂的大脑 动脉瘤的年破裂率约为每100，000人中有8至10例（美国每年约有30，000例）， 50%的破裂病例死亡，66%的存活病例发生永久性神经功能缺损。 病例，每年全球有近50万人死亡。 主要的微创外科干预包括使用金属栓塞线圈填充 动脉瘤然而，基于金属的线圈在MRI和CT成像中产生主要伪影，并且还产生 MRI成像中的生物危害发热风险，使关键的术后随访检查复杂化。 EndoShape，Inc.开发的不透射线形状记忆聚合物（SMP）被合并为线圈 MedusaTM第一代外周血管栓塞治疗装置中的多线圈。MedusaTM设备， 使用0.074”大导管展开，在展开过程中具有所需的X线透视可见性，因为 所述多个不透射线的聚合物线圈在展开时同时穿过所述导管并从所述导管出现。 利用FDA在2006年将栓塞弹簧圈重新分类为II类器械的决定，510（k） Medusa？多弹簧圈器械在2014年获得了用于外周血管介入治疗的许可， 为下一代神经血管器械（带不透射线SMP弹簧圈）的510（k）批准开辟了道路。 MedusaTM器械中使用的不透射线SMP对于单弹簧圈器械而言不具有充分的不透射线性 在神经血管应用所需的较小线圈直径范围内。现在一种新的不透射线的 单体，与更有效的交联剂组合使用，在室温下赋予所需的机械性能， 较低的掺入，允许较高的不透射线单体的掺入水平，已经使得所需的 在估计为0.010”-0.021”的导丝直径范围内实现不透射线性，同时保留 所需的性能特性、生物耐久性和生物相容性。EndoShape即将能够 将不透射线的SMP应用于神经血管装置， MedusaTM设备的最新进展 EndoShape SMP的材料优势弥补了金属弹簧圈的缺点，包括 除了术后检查中MRI和CT成像的安全性和有效性的改善外， 以及由于包含EndoShape聚合物基弹簧圈的低成本材料而降低的手术费用。 从2020年到2025年，栓塞治疗设备市场总额预计将从12.6亿美元增加到16.4亿美元。 （+30.2%），预计EndoShape可通过其基于不透射线聚合物的SMP弹簧圈解决市场问题。 从0.89美元增加到11.7亿美元（+31.5%）;突出了EndoShape聚合物弹簧圈的影响， 能够应用于医疗器械市场和改进的栓塞治疗患者护理。

Radiopaque Shape Memory Polymers for Neurovascular Embolotherapy Applications Project Summary / Abstract This Phase I project involves a major improvement in neurovascular embolotherapy. Aneurysms contribute significantly to annual mortality: an estimated 6.5 million people in the US (~1 in 50) have an unruptured brain aneurysm, with an annual rupture rate of about 8 to 10 in 100,000 people (about 30,000 annually in the US), with fatality in 50% of the rupture cases and an incidence of permanent neurological deficit in 66% of the surviving cases, and nearly 500,000 deaths worldwide annually. The major minimally invasive surgical intervention involves the use of metal-based embolic coils to fill aneurysms. However, metal-based coils impart major artifacts in MRI and CT imaging, and also impart a biohazard heating risk in MRI imaging, complicating critical follow-up post-surgical examinations. Radiopaque shape-memory polymers (SMPs) developed at EndoShape, Inc. were incorporated as coils in the multi-coil MedusaTM first-generation peripheral vascular embolotherapy device. The MedusaTM device, deployed using a large 0.074” catheter, had the required fluoroscopic visibility during deployment because of the multiple radiopaque polymer coils traversing and emerging from the catheter simultaneously as deployed. Leveraging a decision by the FDA in 2006 to re-classify embolic coils as class II devices, the 510(k) clearance of the MedusaTM multi-coil device for peripheral vascular interventions was achieved in 2014, and opened a pathway to 510(k) clearance of next-generation neurovascular devices with radiopaque SMP coils. The radiopaque SMPs used in the MedusaTM device were not sufficiently radiopaque for single-coil devices in the smaller coil wire diameter range that is required for neurovascular applications. Now a new radiopaque monomer, used in combination with more efficient crosslinkers that impart required mechanical properties at lower incorporation, allowing higher incorporation levels of the radiopaque monomer, has enabled required radiopacity to be achieved in a wire diameter range that is estimated to be 0.010”-0.021” while retaining required performance properties, biodurability and biocompatibility. EndoShape is on the verge of being able to apply radiopaque SMPs to neurovascular devices with the advantages first provided to surgeons by the use of the MedusaTM device. The materials-based advantages of EndoShape SMPs obviate the disadvantages of metal coils, including in addition to the improvements in the safety and efficacy of MRI and CT imaging in post-surgical examinations and a reduction in surgical expense due to the lower-cost materials comprising EndoShape polymer-based coils. From 2020-2025 the total embolotherapy device market is forecasted to increase from $1.26 to $1.64 billion (+30.2%), and the market that EndoShape can address with its radiopaque polymer based SMP coils is expected to increase from $0.89 to $1.17 billion (+31.5%); highlighting the impact EndoShape polymer-based coils are capable of exerting in medical device markets and in improved embolotherapy patient care.