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

• 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
• 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

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.

项目摘要 据估计，超过1000万美国人患有外周动脉疾病（PAD）。不及时治疗 PAD将导致严重的肢体缺血和最终截肢。PAD症状通常会进展，需要以下之一 以下干预：球囊血管成形术、支架置入术或血管旁路术。球囊血管成形术和 药物洗脱支架径向扩张狭窄的动脉--一种损伤血管的机械损伤， 再狭窄和器械失效。这种失效机制导致两种植入物的两年通畅率分别为50%和60%。 血管成形术和药物洗脱球囊。80 - 90%的晚期PAD患者存在以下症状： 股动脉和腘动脉的疾病-其中常见迂曲和复杂的关节运动。这些 复杂的弯曲力加剧了治疗挑战，并经常导致支架断裂和发生率增加 再狭窄。PAD的金标准治疗是外科搭桥术，其本身显示主要2年 解剖结构复杂病变的通畅率高达67%。所有PAD的不可接受的故障率 治疗清楚地表明迫切需要更持久和成功的PAD治疗。 我们的团队已经开发出生物地毯-一种完全可生物降解的静电纺丝片材， 展开后患者血管解剖结构的变化。我们的方法不仅大大减少了 血管壁应力，但也允许Biocapantle的零应力状态是宿主的零应力状态 动脉-其通常是曲折的或解剖学上复杂的。这被假设为进一步减少血管损伤 对管腔内搏动和关节屈曲的反应--这是狭窄血管的常见现象， 下肢外周血管 这个催化剂提案的总体目标是完成生物地毯的设计和原型，建立 其体内输送能力和性能得到改善，并在临床方面取得重大进展 翻译我们的技术。这一目标将通过完成以下目标来实现。R61阶段 该提案有三个目标：R61.1：完成生物地毯设计，制造设备原型， 量化其体外输送能力和性能; R61.2：确定我们器械的体内输送能力， 动脉粥样硬化猪的弯曲关节; R61.3：生成详细说明 在未来向FDA提交申请之前需要的特定里程碑。本提案的R33阶段有两个 目的：R33.1：证明与金标准相比，我们器械的体内性能有所改善 血管内支架; R33.2：生成正式的业务模型文件，详细说明上市的时间轴（需要） 未来投资、市场分析和财务风险预测。该催化奖的资助进一步整合了 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）， 加速我们团队将这一新平台技术转化为临床应用的目标。