New Arterial Sheath for Stroke and Other Neurovascular Interventions.

项目摘要/摘要 卒中，包括缺血性卒中，是世界第二大死因和第五大死因 在美国。最近设备技术的突破性进步导致了血管内中风 治疗成为护理的标准。然而，卒中血栓摘除术(干预)是时间敏感的， 在症状出现后不到16小时内进行干预。病人很少到达护理机构 紧接着出现症状。众所周知，并发症按比例直接增加。 到程序时间，特别是1)每小时功能独立的概率降低7.7% 中风发作到成功再灌注(“时间就是大脑”的概念)，以及2)有时死亡。另外，这几次 由于曲折的解剖结构，敏感的手术有限，在老年人中普遍存在(高达35%)。这又反过来 也会导致更高的并发症发生率，并降低手术成功的机会。具体来说， 神经干预者与困难的解剖学作斗争，往往无法进行这些潜在的生命拯救 28.9%的患者接受了手术治疗。不仅到达目标颅内动脉有延迟，而且辐射也有延迟。 曝光和对比剂剂量也会增加，使患者面临额外的风险。因此，有一个巨大的 需要一种装置来降低失败率并提高难治性主动脉曲张的手术速度 解剖学。公羊医疗创新公司(RAM)开发了一种新型的颈动脉鞘，可以快速、安全地 在这个充满敌意的解剖结构中导航并保持稳定的位置。Ram的可行性工作显示出显著的 更快的颈动脉鞘插入成功率、更少的内皮损伤和更少的辐射暴露 非润滑性原型与断言装置，所有这些装置都有有利的亲水性涂层。在这 直接到第二阶段，Grant RAM计划制造和测试最终的有色护套设备，以演示 产品的安全性和时间效率配置文件。值得注意的是，RAM的设备使用了在其他设备中发现的颜色组件 FDA批准的设备寻求降低当前断言中出现的颗粒脱落的潜在风险。在……里面 为FDA 510(K)应用程序做准备，II类设备，RAM建议进行符合要求的生物兼容性测试 符合FDA指南和ISO协议。这包括细胞毒性、致敏性、刺激性、系统性 毒性(急性)和血液相容性，使用体外和动物模型在 可接受的范围。RAM还计划执行设备消毒、设计验证、包装和 加速老化测试，可确保产品在一年和两年后可靠地运行 绝育手术。包装和灭菌测试也将完成，以符合FDA和ISO标准。 此外，在每次测试过程之后，将对设备进行功能测试，以确保设计仍然有效 很健壮。测试和开发的成功结果将导致一种新的有希望的工具来传递中风 即使在主动脉解剖困难的患者中也能高效、安全地进行治疗。Ram已获得第三方 投资，并在获得FDA批准后，打算与一家大型医疗机构合作或向其销售该产品 用于商业部署的设备制造商。

Project Summary/Abstract Stroke, including ischemic stroke, is the 2nd leading cause of death in the world and 5th leading cause of death in the United States. Recent breakthrough advances in device technology have resulted in endovascular stroke treatment becoming the standard of care. However, stroke thrombectomy (intervention) is time sensitive with a window to intervene in less than 16 hours following symptom onset. Patients rarely arrive to the care facility immediately following the onset of symptoms. It is well-known that complications directly increase in proportion to procedure time, specifically 1) a 7.7% decreased probability of functional independence for every hour of stroke onset to successful reperfusion (“time is brain” concept), and 2) sometimes death. In addition, these time sensitive procedures are limited due to tortuous anatomy, prevalent in the elderly (in up to 35%). This in turn also results in higher complication rates and lessens the chance of procedural success. Specifically, neurointerventionalists struggle with difficult anatomy and often are unable to perform these potentially life-saving procedures in 28.9% of patients. Not only is there a delay in reaching the target intracranial artery, but radiation exposure and contrast dose can also rise, placing the patient at additional risk. Therefore, there is a tremendous need for a device to decrease the failure rate and improve the speed of this procedure in difficult tortuous aortic anatomy. RAM Medical Innovations (RAM) has developed a novel carotid sheath that can quickly and safely navigate as well as maintain stable position in this hostile anatomy. RAM's feasibility work showed significantly faster carotid sheath insertion success rate, less endothelial injury, and reduced radiation exposure with our nonlubricious prototype against predicate devices, all of which have an advantageous hydrophilic coating. In this Direct to Phase 2 grant RAM plans to make and test the finalized, lubricious sheath device to demonstrate the product's safety and time efficiency profile. Notably, RAM's device, using a lubricious component found in other FDA approved devices seeks to reduce the potential risk of particle shedding seen with current predicates. In preparation for FDA 510(k) application, Class II device, RAM proposes biocompatibility testing in compliance with the FDA guidelines and ISO protocols. This would include cytotoxicity, sensitization, irritation, systemic toxicity (acute) and hemocompatibility, using in vitro and animal models to establish measurements within acceptable ranges. RAM also plans to perform device sterilization, design verification, packaging and accelerated aging tests that will ensure that the product will perform reliably one-year and two-years post sterilization. Packaging and sterilization testing will also be completed to conform to FDA and ISO standards. Additionally, after each testing process, the device will be functionally tested to ensure that the design is still robust. Successful outcomes in testing and development will result in a new promising tool to deliver stroke treatment efficiently and safely even in patients with difficult aortic anatomy. RAM has obtained third party investments and, after obtaining FDA clearance, intends to partner with or sell the product to a major medical device manufacturer for commercial deployment.