A new absorbable mesh for hernia repair

描述（由申请人提供）：本项目的目标是开发一种上级现有产品的可吸收疝补片，并可通过FDA的510 k上市前通知程序获得批准。与现有产品相比，由Tepha的PHA 4400生物材料制成的可吸收补片具有几个关键优势，并且市场上更轻、更柔韧和部分可吸收补片的趋势明确表明了这一点。补片的可吸收性将减少晚期瘘和感染风险以及可能的组织粘连。纤维的更大柔性将降低补片刚度，并且最终吸收将降低所得组织修复的刚度。该产品预计将在当前合成不可吸收补片结局不佳的情况下得到进一步应用，例如植入受污染的手术野，或植入可能阻碍生长的儿科患者。如果证明这种新补片上级现有选项，则可以从这种新补片中受益的患者总数很大。每年大约进行150万例腹股沟疝修补手术和20万例腹疝手术。该研究方法将采用一种新的可吸收生物材料，称为聚-4-羟基丁酸酯（也称为PHA 4400），与现有的可吸收缝线生物材料相比，该材料已被证明具有延长的体内强度保留。该项目的具体目标是：（1）制备三种配置的PHA 4400补片，其初始爆破强度与商业合成材料相当（聚丙烯）疝补片;（2）在疝修补动物模型中评价新补片配置，并选择最合适的补片进行进一步开发;（3）评价成品器械的生物相容性;（4）开发方法来表征成品器械的拉伸强度、缝线拔出强度、爆破强度和抗撕裂性;（5）在长期动物植入研究中确定补片的降解特征;（6）在动物模型中评价补片用于疝修补术的手术功能;（7）在一年加速老化研究中评价产品和包装的稳定性。除了FDA的具体要求外，如果时间允许，我们还计划（a）评价补片抗粘连的能力，以及（B）评价该补片在污染手术野中的实用性和/或确定在感染环境中的兼容性潜力。除了开发一种可以改善疝修补手术结果的产品外，该研究还将有助于将一种新的可吸收医用生物材料引入医学界，该材料可以在控释，组织工程和其他设备中找到其他用途。本项目的目的是使用新型可吸收生物材料开发一种新型改良疝补片。预计该产品可降低当前疝修补术引起的并发症的发生率。如果证明该产品优于现有疝补片，则大量患者可从该产品中受益，因为每年有超过150万患者接受疝修补术。

DESCRIPTION (provided by applicant): The goal of this project is to develop an absorbable hernia mesh that is superior to existing products and can be cleared through the FDA' 510k premarket notification process. An absorbable mesh made of Tepha's PHA4400 biomaterial would have several key advantages over existing products and is clearly indicated by the trend in the market place towards lighter, more flexible and partially absorbable meshes. The absorbability of the mesh would reduce late term fistula and risk of infection and possibly tissue adhesions. Greater flexibility of the fiber will reduce mesh stiffness and eventual absorption will reduce the stiffness of the resulting tissue repair. The product is expected to find further application where current synthetic non-absorbable meshes provide poor outcomes, such as implantation in contaminated surgical fields, or in pediatric patients where they can hinder growth. The total number of patients that could benefit from this new mesh is large if it proves to be superior to existing options. Approximately, 1.5 million inguinal hernia repair procedures and 200,000 ventral hernia procedures are performed each year. The research approach will employ a new absorbable biomaterial, known as poly-4-hydroxybutyrate (also known as PHA4400), that has been shown to have prolonged strength retention in vivo compared to existing absorbable suture biomaterials. The specific aims of the project are to: (1) prepare three configurations of a PHA4400 mesh with an initial burst strength comparable to commercial synthetic (polypropylene) hernia meshes; (2) evaluate the new mesh configurations in an animal model for hernia repair and select the most appropriate mesh for further development; (3) evaluate the biocompatibility of the finished device; (4) develop methods to characterize the finished device for tensile strength, suture pullout strength, burst strength and tear resistance; (5) determine the degradation profile for the mesh in a long- term animal implantation study; (6) evaluate the surgical functionality of the mesh for hernia repair in an animal model; (7) evaluate the stability of the product and package in a one-year accelerated aging study. In addition to the FDA's specific requirements, if time allows, we also plan to (a) evaluate the ability of the mesh to resist adhesions, and (b) evaluate the utility of this mesh in a contaminated surgical field and/or determine the potential for compatibility in a setting of infection. In addition to developing a product that could improve surgical outcomes of hernia repair procedures, the research will also help to introduce a new absorbable medical biomaterial into the medical community that could find other uses, for example, in controlled release, tissue engineering, and other devices. The objective of this project is to develop a new improved hernia mesh using a novel absorbable biomaterial. It is anticipated that the product could reduce the incidence of complications resulting from current hernia repair procedures. A large number of patients could benefit from this product if it proves to be better than existing hernia meshes as more than 1.5 million patients undergo hernia repair procedures each year.