P4HB degrades gradually and predictably by hydrolysis into components that are natural to the human body, resulting in a minimal inflammatory response with less acidic byproducts or remodeling challenges, as compared to other soft tissue support devices.
P4HB belongs to a large group of naturally occurring biopolymers, known as polyhydroxyalkanoates (PHAs). PHAs exist in nature as energy reserves in microorganisms that can be stored up and broken down as needed.
In contrast to other polymers used today for soft tissue support, P4HB is biologically derived through a proprietary biological fermentation process, rather than chemical synthesis.
P4HB has a unique set of properties, particularly in comparison to other polymers commonly used in absorbable medical devices, such as polyglycolide (PGA) and polylactide (PLA), which are inherently stiffer materials. The properties of P4HB make it possible to produce high strength biomaterial without sacrificing elasticity to yield strong, pliable monofilament fibers.
After P4HB is isolated and purified, it can be extruded into monofilament fibers and either used directly as suture or knitted into an open scaffold construction. P4HB scaffolds are designed to encourage rapid tissue ingrowth and to reduce the risk of infection.
P4HB devices have been tested in pre-clinical and clinical studies to evaluate safety and effectiveness [2,18,19]
More than 4 million patients worldwide have been implanted with P4HB devices.
Disclaimer: The discussion points in the graphic (at right) are in the context of the general literature, and not indicative of results from a head-to-head study.