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

注意：这些页面包含专有/特权信息。SIA要求不将它们释放给 政府以外的机构，但审查和评估的目的除外。 项目摘要/摘要 DuraSorb™将显著改善100,000多名接受术后护理的美国女性的生活 每年都会进行乳房切除、乳房再造。 植入物乳房重建(IBBR)目前的护理标准是使用身体脱细胞乳房 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在10多年前推出，旨在提供减少疼痛、减少回访的技术优势 在重建阶段之间，获得更好的美容效果，并降低周围囊膜痉挛的发生率 植入物。然而，它与手术部位并发症的风险增加10%有关。 包括浆液瘤、感染和皮瓣坏死。此外，它的成本是不可持续的，每台3500-4850美元 胸部。早在2007年，人们就开始了对替代合成网格的研究。然而，到目前为止，研究 仅限于具有短期随访的小病例系列，并使用在疝修补术中可能容忍的网片， 但目前临床上仍存在细小血管的乳房切除皮瓣的设置问题。 DuraSorb™是由聚二恶酮制成的，这是一种众所周知的聚合物，是用于 可植入的装置。对材料的最小炎症反应及其在6-9年内的完全降解 几个月的时间可以预防慢性炎症，并使DuraSorb™具有生物网状的特征。另外， 它的开放式大孔设计允许组织整合。此外，它是用单丝纤维生产的， 它们比ADM更不容易形成生物被膜。合成的DuraSorb™的独特性质可以 在不增加并发症的情况下提供ADM的技术优势，且成本仅为ADM的五分之一。 在这个直接到第二阶段的SBIR方案中，SIA将获得实现第一个也是唯一的 FDA在美国批准假体乳房重建术，超过为 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，倾向匹配的对照，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果。 注意：这些页面包含专有/特权信息。SIA要求不将它们释放给 政府以外的机构，但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.