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

注：这些页面包含专有/特权信息。SIA要求不要将这些照片发布给 政府以外的，但为审查和评估的目的除外。 项目总结/摘要 DuraSorb™有望显著改善10万多名美国妇女的生活， 乳房切除术乳房再造。 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置于胸肌下 肌肉. ADM于10多年前推出，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，以及周围包囊挛缩率降低 植入物然而，它与手术部位并发症风险增加10%相关 包括血清肿感染和皮瓣坏死。此外，它有一个不可持续的成本为3，500 - 4，850美元， 乳房早在2007年就已经在研究替代合成补片。然而，到目前为止，研究 仅限于随访时间较短的小病例系列，并使用疝修补术中可耐受的补片， 但是在设置具有纤细血管的乳房切除术皮瓣时存在临床问题。 DuraSorb™由聚对二氧环己酮制成，聚对二氧环己酮是一种众所周知的聚合物，是在外科手术中使用的炎症最小的聚合物之一。 植入式装置对材料的最小炎症反应及其完全降解超过6-9 数月可预防慢性炎症，并赋予DuraSorb™生物补片的特性。此外，本发明还 其开孔编织的大孔设计允许组织整合。此外，它是用单丝纤维生产的， 合成DuraSorb™的独特性能可以 在不增加并发症的情况下提供ADM的技术优势，并且成本只有ADM的五分之一。 在这份直接进入II期SBIR的提案中，SIA将获得实现第一个也是唯一一个 FDA批准美国的假体乳房重建，超出了收集的临床数据， 510（k）许可（2018年8月，K181094）。将进行一项100例患者的多中心单组试验， 回顾性、倾向匹配对照，以证明DuraSorb™的性能和安全性，并 在临床试验中评估患者报告的结局。 注：这些页面包含专有/特权信息。SIA要求不要将这些照片发布给 政府以外的，但为审查和评估的目的除外。

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.