Galatea surgical scaffolds are part of a new generation of devices for soft tissue reinforcement made from high strength bioresorbable fibers of poly-4-hydroxybutyrate (P4HB).

 

P4HB

P4HB belongs to a large group of naturally occurring biopolymers, known as PHAs or polyhydroxyalkanoates. PHAs have been referred to as the fifth class of important naturally occurring polymers alongside polyisoprenoids, polypeptides, polysaccharides, and polynucleotides. [22] PHAs are biosynthesized in nature by microorganisms as energy reserve materials that can be stored up and broken down when needed.

Watch the Galatea Scaffold Collection Overview.

P4HB has a very unique set of properties, particularly in comparison to other polymers commonly used in resorbable medical devices, such as polyglycolide (PGA) and polylactide (PLA), which are inherently much stiffer materials.  The properties of P4HB make it possible to produce high strength biomaterial without sacrificing elasticity to yield strong, pliable monofilament fibers.  

In contrast to other polymers used today for soft tissue support, P4HB is produced through a proprietary biologic fermentation process, rather than chemical synthesis. 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 designed for rapid tissue in-growth and low bacterial adherence. [18] 

P4HB has been tested extensively in pre-clinical studies to evaluate its safety profile and more than 1 million patients worldwide have been implanted with P4HB devices with a very low number of complaints.

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