Radiopaque Shape Memory Polymers for Neurovascular Embolotherapy Applications

辐射不透光形状记忆聚合物 神经血管栓塞术的应用 项目摘要/摘要 这个第一阶段的项目涉及神经血管栓塞术的重大改进。动脉瘤是导致 每年的死亡率显著上升：据估计，美国有650万人(约每50人中有1人)大脑没有破裂 动脉瘤，年破裂率约为每10万人中有8至10人(美国每年约为30,000人)， 50%的破裂病例死亡，66%的存活者发生永久性神经功能障碍 全球每年有近500,000人死亡。 主要的微创外科干预包括使用金属栓塞圈来填充 动脉瘤。然而，基于金属的线圈在MRI和CT成像中提供了主要的伪影，也提供了 核磁共振成像中的生物危害加热风险，使手术后的关键后续检查复杂化。 将由EndoShape，Inc.开发的不透射线形状记忆聚合物(SMPS)合并为线圈 在多线圈MedusaTM第一代外周血管栓塞术设备中。MedusaTM设备， 使用大型0.074英寸导管部署，在部署过程中具有所需的透视可见性，因为 在展开时，多个不透射线的聚合物线圈同时穿过导管并从导管中涌出。 利用FDA在2006年做出的将栓塞圈重新归类为II类设备的决定，510(K) 用于外周血管干预的MedusaTM多线圈装置于2014年获得批准，以及 开辟了一条途径，通过不透射线的SMP线圈清除下一代神经血管设备的510(K)。 MedusaTM设备中使用的不透射线SMPS对单线圈设备不够透射线 在神经血管应用所需的较小线圈线直径范围内。现在，一种新的不透射线材料 单体，与更高效的交联剂结合使用，可提供所需的机械性能 较低的掺入，允许较高的不透射线单体的掺入水平，使所需的 在钢丝直径估计为0.010“-0.021”的范围内实现的放射不透明度，同时保持 要求的性能特性、生物耐受性和生物兼容性。EndoShape即将能够 将不透射线的SMPS应用于神经血管装置，其优点首先通过使用 MedusaTM设备的。 EndoShape开关电源基于材料的优势消除了金属线圈的缺点，包括 除了在手术后检查中MRI和CT成像的安全性和有效性的改进之外 以及由于包含基于EndoShape聚合物的线圈的低成本材料而减少了手术费用。 从2020年到2025年，栓塞术设备的总市场预计将从12.6亿美元增加到16.4亿美元 (+30.2%)，预计EndoShape可以通过其基于辐射不透明聚合物的SMP线圈来满足市场需求 从0.89美元增加到11.7亿美元(+31.5%)；突出了基于EndoShape聚合物的线圈的影响 能够在医疗器械市场发挥作用，并在改善栓塞术患者护理方面发挥作用。

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.