Development of a Balloon Occlusion Sheath for Stroke (BOSS)

开发用于中风的球囊闭塞鞘 (BOSS)

• 批准号: 10004173
• 负责人: Brady Hatcher
• 金额: $ 98.54万
• 依托单位: MARBLEHEAD MEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10004173
• 关键词: Acute; Adopted; Adoption; Anatomy; Animal Experiments; Animal Model; Arterial Injury; Arteries; Award; Balloon Occlusion; Blood Vessels; Cadaver; Caring; Carotid Arteries; Catheters; Characteristics; Clinic; Clinical; Coagulation Process; Communities; Development; Device Removal; Devices; Distal; Embolism; Endothelium; Engineering; Excision; Family suidae; Grant; Growth; Hemorrhage; Hybrids; In Vitro; Injury; Interview; Ischemic Stroke; Laboratories; Lead; Length; Mechanics; Medical; Methods; Modeling; Modification; Neurological outcome; Neurons; Patient-Focused Outcomes; Patients; Phase; Physicians; Physiology; Population; Pre-Clinical Model; Preclinical Testing; Preparation; Procedures; Regulatory Pathway; Resistance; Retrieval; Risk; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Speed; Stroke; System; Testing; Thick; Thrombectomy; Time; Translating; Validation; Vision; Visit; Work; base; clinical research site; design; experience; flexibility; improved; in vivo; in vivo evaluation; innovation; interest; mortality; neurovascular; novel; older patient; pre-clinical; preservation; prevent; replicator; stem; stroke outcome; stroke patient; success; usability

PROJECT ABSTRACT Acute ischemic stroke care has been revolutionized in the past 3 years, with multiple trials showing the efficacy of mechanical thrombectomy retrieval devices. Because of this revolution, there are many clinical needs for improved adjunctive devices that have not kept up with the swift growth of the thrombectomy field. This Phase II SBIR grant will support Good Lab Practices animal models testing Marblehead Medical’s innovative balloon guide device, the Balloon Occlusion Sheath for Stroke (BOSS), as well as FDA submission. Thus, the BOSS will be tested in the best available preclinical models against the best existing balloon guide devices for acute ischemic stroke and bring this device, which has crucial usability innovations and a novel balloon material, to tens of thousands of stroke patients a year undergoing mechanical thrombectomy. Balloon devices like BOSS have proven improvements in patient outcomes—half the mortality and double the rate of good neurological outcome—but less than 25% of stroke interventionalists use them because of technical limitations that BOSS is specifically designed to overcome based on intensive interviews with 80 physicians. BOSS not only has a more durable, compliant, and usable balloon, but also increases the inner lumen size without a larger arteriotomy, thus allowing the largest and best retrieval devices to be used without introducing greater hemorrhage risks. BOSS achieves this through a more stable braid-and-coil combination device that can be used for both arterial access and flow arrest in the carotid artery, simplifying and speeding stroke procedures. We have also discovered two further unmet clinical needs in the stroke community: stability is the most important usability characteristic to device companies and interventionalists, and no current device provides maximized advancement into to the carotid artery (which contributes to stability). Furthermore, older patients tend to have tortuous carotid anatomies, preventing navigation by all but the most flexible catheters. Therefore, this grant would also support creating BOSS Slender, a novel iteration of BOSS that optimizes stability (through a stiff catheter along most of its length) while also maximizing advancement (through a flexible, narrowed distal tip). This will also make Marblehead Medical a portfolio company offering a suite of specialized devices to allow physiology-specific treatment to the growing population of stroke patients. Thus, Marblehead Medical has assembled an experienced team of neurovascular engineers, quality experts, and regulatory writers to work alongside Mayo Clinic’s specialized preclinical stroke laboratory to translate BOSS and its diverse follow-on devices to clinical use; we have also received interest from strategic device companies and established 8 early adopter key opinion leaders at major clinical sites. This grant will provide support for the key development, preclinical, and regulatory work to put BOSS devices on the market and drive adoption of the best-proven neurovascular accessory devices through usability innovations. This would bring us closer to our vision of improving patient outcomes and preventing mortality for patients afflicted by stroke.

项目摘要 急性缺血性中风治疗在过去三年里发生了革命性的变化，多项试验显示其疗效 由于这场革命，出现了许多临床需求。 改进的辅助装置未能跟上本阶段血栓切除术领域的快速发展。 II SBIR 拨款将支持良好实验室实践动物模型测试 Marblehead Medical 的创新气球 引导装置、中风球囊闭塞鞘 (BOSS) 以及 FDA 提交的文件。 将在最佳可用的临床前模型中针对急性急性期现有最佳球囊引导装置进行测试 缺血性中风并将该具有关键可用性创新和新型球囊材料的设备带到 每年有数以万计的中风患者接受 BOSS 等机械血栓切除术。 事实证明，患者的治疗效果有所改善——死亡率降低一半，神经系统良好率提高一倍 结果——但由于 BOSS 的技术限制，只有不到 25% 的中风介入医生使用它们 基于对80名医生的深入访谈而专门设计的克服BOSS不仅有一个。 更耐用、更顺应、更可用的球囊，而且还增加了内腔尺寸，而无需更大的球囊 动脉切开术，从而允许使用最大和最好的检索设备，而无需引入更大的 BOSS 通过更稳定的编织物和线圈组合装置实现了这一点。 用于颈动脉的动脉通路和血流阻滞，简化和加速中风手术。 我们还发现中风界还有两个未满足的临床需求：稳定性是最重要的 对于设备公司和介入医生来说很重要的可用性特征，但当前的设备没有提供 最大限度地进入颈动脉（这有助于稳定）。 颈动脉往往具有曲折的解剖结构，除了最灵活的导管之外，其他导管都无法导航。 这笔赠款还将支持创建 BOSS Slender，这是 BOSS 的一种新型迭代，可优化稳定性 （通过沿其大部分长度的刚性导管），同时也最大限度地推进（通过灵活的， 这也将使 Marblehead Medical 成为一家提供一系列专业产品的投资组合公司。 为不断增长的中风患者提供生理学特异性治疗的设备。 因此，Marblehead Medical 组建了一支经验丰富的团队，由神经血管工程师、质量专家、 和监管编写人员与梅奥诊所的专业临床前卒中实验室合作进行翻译 BOSS 及其多种临床后续设备也引起了我们的兴趣； 这笔赠款将提供公司并在主要临床中心建立 8 位早期采用者关键意见领袖。 支持关键开发、临床前和监管工作，以将 BOSS 设备推向市场并推动 通过可用性创新，采用经过充分验证的神经血管辅助设备。 我们更接近改善患者治疗结果并预防中风患者死亡的愿景。