Biocarpet: The Next Generation Endovascular Device for Peripheral Arterial Disease

Biocarpet：治疗外周动脉疾病的下一代血管内装置

基本信息

批准号：
10744597
负责人：
Jonathan Pieter Vande Geest
金额：
$ 39.75万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-01 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10744597
关键词：
Acceleration American Amputation Anatomy Angioplasty Arteries Award Balloon Angioplasty Blood Platelets Blood Vessels Body Temperature Businesses Bypass Catheters Clinical Clinical Treatment Complex Devices Disease Equipment Malfunction Exercise Failure Family suidae Fracture Funding Future Goals Grant Histology Human Resources Image Immune response In Situ In Vitro Intervention Investments Joints Knee Left Legal patent Lesion Lower Extremity Marketing Mechanical Stress Mechanics Modeling Morbidity - disease rate Motion Operative Surgical Procedures Outcome Patients Performance Peripheral Peripheral arterial disease Pharmaceutical Preparations Phase Proteins Radial Research Risk Shapes Stents Stress Structure of popliteal artery Symptoms Technology Temperature Time Translating Treaty advanced disease arterial tortuosity clinical translation commercialization critical limb Ischemia design femoral artery improved in vivo next generation novel prototype response restenosis scaffold smoking cessation standard care stress state technology platform timeline two-dimensional vascular injury

项目摘要

Project Summary It is estimated that over 10 million Americans have peripheral arterial disease (PAD). Left untreated PAD will lead to critical limb ischemia and eventual amputation. PAD symptoms often progress requiring one of the following interventions: balloon angioplasty, stent placement, or vascular bypass. Balloon angioplasty and drug eluting stents radially expand stenosed arteries -- a mechanical insult that damages the vessel leading to restenosis and device failure. This failure mechanism leads to a two-year patency rate of 50% and 60% for angioplasty and drug eluting balloons, respectively. 80 to 90% of patients with advanced PAD present with disease in the femoral and popliteal arteries – where tortuosity and complex joint motion is common. These complex bending forces exacerbate treatment challenges and often lead to stent fracture and increased rates of restenosis. The gold standard treatment of PAD is surgical bypass, which itself displays a primary 2 year patency rate of up to 67% for anatomically complex lesions. The unacceptable failure rates of all PAD treatments clearly demonstrate the critical need for a more durable and successful treatment of PAD. Our team has developed the Biocarpet – a fully biodegradable electrospun sheet that takes the shape of the patient’s vascular anatomy following deployment. Our approach not only imposes significantly reduces vascular wall stress during deployment, but also allows the Biocarpet’s zero stress state to be that of the host artery – which is often tortuous or anatomically complex. This is hypothesized to further reduce vascular injury in response to intraluminal pulsation and joint flexion – a common occurrence in the stenotic vessels of the lower limb peripheral vasculature. The overall goal of this Catalyze proposal is to finalize the Biocarpet design and prototype, establish its deliverability and improved performance in-vivo, and make significant progress toward the clinical translation of our technology. This goal will be met by completing the following objectives. The R61 phase of this proposal has three Objectives: R61.1: Finalize the Biocarpet design, fabricate a device prototype, and quantify its in-vitro deliverability and performance; R61.2: Establish the in-vivo deliverability of our device into the bending joint of an atherosclerotic pig; R61.3: Generate a Regulatory Path document that details the specific milestones that are required prior to a future FDA submission. The R33 phase of this proposal has two objectives: R33.1: Demonstrate the improved in-vivo performance of our device compared to a gold standard endovascular stent; R33.2: Generate a formal Business Model document detailing timeline to market, required future investment, market analysis, and financial risk profile. Funding of this Catalyze award further integrate our research team with the procured Accelerator Partners (including both regulatory and business expertise) to accelerate our team’s goal of clinical translating this novel platform technology.

项目概要据估计，超过 1000 万美国人患有外周动脉疾病 (PAD)，但未得到治疗。 PAD 会导致严重的肢体缺血，最终 PAD 症状通常会进展，需要其中一种。以下干预措施：球囊血管成形术、支架置入术或血管搭桥术。药物洗脱支架径向扩张狭窄的动脉——一种机械损伤，会损害血管，导致这种失效机制导致两年通畅率分别为 50% 和 60%。 80% 至 90% 的晚期 PAD 患者分别接受血管成形术和药物洗脱球囊治疗。股动脉和腘动脉疾病——弯曲和复杂的关节运动很常见。复杂的弯曲力使治疗挑战恶化，并经常导致支架断裂和发生率增加 PAD 的金标准治疗是外科搭桥手术，其本身显示主要 2 年。对于解剖结构复杂的病变，通畅率高达 67% 所有 PAD 的失败率都令人无法接受。治疗清楚地表明迫切需要更持久和成功的 PAD 治疗。我们的团队开发了 Biocarpet——一种完全可生物降解的电纺片材，其形状我们的方法不仅显着减少了部署后患者的血管解剖结构。部署期间的血管壁应力，但也允许生物地毯的零应力状态为宿主的零应力状态动脉——通常是曲折的或解剖结构复杂的，这是为了进一步减少血管损伤而开发的。响应腔内搏动和关节屈曲——这在狭窄血管中很常见下肢周围血管系统。该 Catalyze 提案的总体目标是最终确定生物地毯的设计和原型，建立其体内递送能力和性能得到改善，并在临床上取得重大进展我们的技术的转化将通过完成以下 R61 阶段的目标来实现。该提案有三个目标： R61.1：最终确定生物地毯设计，制造设备原型，以及量化其体外传递性和性能；R61.2：将我们的设备的体内传递性确定为动脉粥样硬化猪的弯曲关节；R61.3：生成详细说明的监管路径文件该提案的 R33 阶段在未来向 FDA 提交之前所需的具体里程碑有两个。目标：R33.1：展示我们的设备与黄金标准相比改进的体内性能 R33.2：生成正式的商业模式文件，详细说明上市时间（需要）该 Catalyze 奖项的未来投资、市场分析和财务风险状况进一步整合。我们的研究团队与采购的加速器合作伙伴（包括监管和业务专业知识）加速我们团队实现临床转化这一新颖平台技术的目标。