First and Only Soft Tissue Support Device to Improve Patient Experience and System Cost in Breast Reconstruction

第一个也是唯一一个软组织支持装置，可改善乳房重建中的患者体验和系统成本

• 批准号: 9909872
• 负责人: John Y Kim
• 金额: $ 46.7万
• 依托单位: SURGICAL INNOVATION ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-20 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9909872
• 关键词: Appearance; Area; Biological; Biopsy; Blood Vessels; Breast; Cadaver; Case Series; Characteristics; Chronic; Client satisfaction; Clinic Visits; Clinical; Clinical Data; Clinical Trials; Collagen; Contracture; Cosmetics; Data; Deposition; Dermal; Devices; Economics; Effectiveness; Evaluation; Failure; Fiber; Goals; Government; Grant; Hernia; Human; Implant; Infection; Inflammation; Inflammatory; Inflammatory Response; Label; Mammaplasty; Marketing; Mastectomy; Microbial Biofilms; Muscle; Necrosis; Operative Surgical Procedures; Outcome; Pain; Pathway interactions; Patient Outcomes Assessments; Patients; Pectoralis Muscles; Performance; Persons; Phase; Polymers; Procedures; Property; Prosthesis; Protocols documentation; Randomized Controlled Trials; Research Design; Risk; Safety; Sample Size; Seroma; Site; Skin; Small Business Innovation Research Grant; Surgical Flaps; Surgical Mesh; System; Techniques; Time; Tissue Expanders; Tissues; Visit; Woman; arm; base; capsule; cost; cost effective; design; experience; follow-up; human tissue; implantable device; improved; innovation; malignant breast neoplasm; meetings; prevent; primary endpoint; psychologic; reconstruction; repaired; soft tissue; standard of care; surgical risk

NOTE: These pages contain proprietary/privileged information. SIA requests that they not be released to persons outside the Government, except for purposes of review and evaluation. Project Summary/Abstract DuraSorb™ is poised to significantly improve the lives of the over 100,000 US women undergoing post- mastectomy breast reconstruction every year. The current standard of care in implant-based breast reconstruction (IBBR) is the use of cadaveric acellular dermal matrix (ADM) as a sling for the implant, rather than placing the implant fully under the pectoralis muscle. ADM was introduced 10+ years ago to provide technical benefits of decreased pain, fewer return visits between reconstructive stages, better cosmetic results, and decreased rates of capsular contracture around the implant. However, it has been associated with a 10% increase in risk of surgical site complications including seroma, infection, and flap necrosis. Furthermore, it has an unsustainable cost of $3,500-$4,850 per breast. Alternative synthetic meshes have been being investigated as early as 2007. However, to date, studies are limited to small case series with short follow-up and utilize meshes that may be tolerated in a hernia repair, but present clinical problems in the setting of a mastectomy skin flap with tenuous vascularity. DuraSorb™ is made of polydioxanone, a well-known polymer that is among the least inflammatory used in implantable devices. The minimal inflammatory response to the material and its full-degradation over 6-9 months prevent chronic inflammation and give DuraSorb™ the characteristics of a biologic mesh. Additionally, its open-knit, macroporous design allows for tissue integration. Further, it is produced with monofilament fibers, which are less prone to biofilm formation than ADM. The unique properties of synthetic DuraSorb™ could deliver the technical benefits of ADM without the increased complications, and at a fifth of the cost. In this Direct to Phase II SBIR proposal, SIA will acquire the clinical data required to achieve the first and only FDA clearance for prosthetic breast reconstruction in the US, above and beyond the clinical data collected for 510(k) clearance (August 2018, K181094). A 100 patient multi-center single arm trial will be conducted with a retrospective, propensity-matched control to demonstrate performance and safety of DuraSorb™ and to evaluate patient reported outcomes in a clinical trial. NOTE: These pages contain proprietary/privileged information. SIA requests that they not be released to persons outside the Government, except for purposes of review and evaluation.

注意：这些页面包含专有/特权信息。 SIA 要求不要将它们透露给任何人 政府以外的范围，但出于审查和评估目的除外。 项目概要/摘要 DuraSorb™ 有望显着改善超过 100,000 名接受术后治疗的美国女性的生活 每年进行乳房切除术和乳房重建术。 目前基于植入物的乳房重建 (IBBR) 的护理标准是使用尸体脱细胞 真皮基质 (ADM) 作为植入物的吊带，而不是将植入物完全放置在胸肌下方 肌肉。 ADM 于 10 多年前推出，旨在提供减轻疼痛、减少回访的技术优势 在重建阶段之间，更好的美容效果，并降低周围包膜挛缩的发生率 植入物。然而，它与手术部位并发症的风险增加 10% 有关 包括血清肿、感染和皮瓣坏死。此外，每个项目的成本为 3,500-4,850 美元，不可持续。 胸部。早在 2007 年，人们就开始研究替代合成网格。然而，迄今为止，研究 仅限于随访时间短的小病例系列，并使用疝气修复中可以耐受的网片， 但在具有脆弱血管的乳房切除皮瓣的设置中存在临床问题。 DuraSorb™ 由聚二氧环己酮制成，这是一种众所周知的聚合物，是用于治疗中炎症性最小的聚合物之一。 植入式设备。对材料的最小炎症反应及其在 6-9 时间内的完全降解 几个月可预防慢性炎症，并赋予 DuraSorb™ 生物网的特性。此外， 其开放式针织大孔设计允许组织整合。此外，它是用单丝纤维生产的， 与 ADM 相比，它们不易形成生物膜。合成 DuraSorb™ 的独特性能可以 提供 ADM 的技术优势，同时不会增加复杂性，成本仅为 ADM 的五分之一。 在这项直接进入 II 期 SBIR 提案中，SIA 将获取实现第一个也是唯一一个所需的临床数据 FDA 批准在美国进行假体乳房重建，超出了收集的临床数据 510(k) 许可（2018 年 8 月，K181094）。将进行 100 名患者的多中心单臂试验 回顾性、倾向匹配控制，以证明 DuraSorb™ 的性能和安全性，并 评估临床试验中患者报告的结果。 注意：这些页面包含专有/特权信息。 SIA 要求不要将它们透露给任何人 政府以外的范围，但出于审查和评估目的除外。