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' s 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. ? ? ? ?
