For those publications discussing use of Galatea surgical scaffolds (GalaFLEX®, GalaSHAPE® 3D or GalaFORM® 3D), the FDA does not consider the use of these products as described in the publications to be within the cleared indications for use for each device. Significant safety risks or safety concerns associated with the use of Galatea scaffolds known to the manufacturer are described in the Instructions for Use for each of those devices.  

Poly-4-hydroxybutyrate (P4HB) in Biomedical Applications and Tissue Engineering

Category: Review
+ More

Guo, Kai, Martin, David

Biodegradable Polymers 2(7):199-231.2015

Link to Publication: https://www.researchgate.net/publication/290183665_Poly-4-hydroxybutyrate_P4HB_in_Biomedical_Applications_and_Tissue_Engineering

ABSTRACT

Poly-4-hydroxybutyrate (P4HB) is a resorbable, thermoplastic homopolyester with a linear chain structure of 4-hydroxybutyrate monomers. High molecular weight P4HB is difficult to synthesize chemically but can be produced via a recombinant bacterial fermentation process through biologic catalysis using enzymes from the polyhydroxyalkanoate biosynthetic pathway. Due to its biocompatibility and biodegradability, as well as its unique mechanical properties, P4HB has emerged during the last decade as a promising biomaterial for various biomedical applications including tissue engineering (congenital heart defects, heart valves and vascular grafts), suture materials, and surgical textiles. In 2007, the TephaFLEX® absorbable monofilament suture was the first medical device derived from P4HB cleared for clinical use by the Food and Drug Administration (FDA) in the United States. Since then, additional regulatory clearances in the US and Europe have expanded the applications of P4HB products to include devices for hernia repair, tendon and ligament repair, and plastic and reconstructive surgery. This chapter will review the unique characteristics of P4HB polymer for use in resorbable medical evices, its processing into various forms, together with strategies that can be used to tailor the material properties for a variety of clinical applications. A number of exciting tissue engineering products based on P4HB that are currently in development, including vascular grafts and heart valves, will be presented as well as examples of potential future medical applications of P4HB in regenerative medicine.

DISCLOSURE:

 Dr. David Martin is the Chief Scientific Officer of Tepha, Inc. Kai Guo is an employee of Tepha, Inc.

The History of GalaFLEX P4HB Scaffold

Category: Review
+ More

Simon F. Williams, PhD; David P. Martin, PhD; and Arikha C. Moses, PhD

Aesthetic Surgery Journal 36(2):S33-S42. 2016   

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/27697885

ABSTRACT

The GalaFLEX Scaffold (Galatea Surgical, Inc., Lexington, MA) for plastic and reconstructive surgery belongs to a new generation of products for soft tissue reinforcement made from poly-4- hydroxybutyrate (P4HB). Other members of this new family of products include MonoMax Suture (Aesculap AG, Tuttlingen, Germany) for soft tissue approximation, BioFiber Scaffold (Tornier, Inc., Edina, MN) for tendon repair, and Phasix Mesh (C.R. Bard, Inc., Murray Hill, NJ) for hernia repair. Each of these fully resorbable products provides prolonged strength retention, typically 50% to 70% strength retention at 12 weeks, and facilitates remodeling in vivo to provide a strong, lasting repair. P4HB belongs to a naturally occurring class of biopolymers and fibers made from it are uniquely strong, flexible, and biocompatible. GalaFLEX Scaffold is comprised of high-strength, resorbable P4HB monofilament fibers. It is a knitted macroporous scaffold intended to elevate, reinforce, and repair soft tissue. The scaffold acts as a lattice for new tissue growth, which is rapidly vascularized and becomes fully integrated with adjacent tissue as the fibers resorb. In this review, we describe the development of P4HB, its production, properties, safety, and biocompatibility of devices made from P4HB. Early clinical results and current clinical applications of products made from P4HB are also discussed. The results of postmarket clinical studies evaluating the GalaFLEX Scaffold in rhytidectomy andcosmetic breast surgery demonstrate that the scaffold can reinforce lifted soft tissue, resulting in persistent surgical results in the face and neck at one year, and provide lower pole stability after breast lift at one year.

DISCLOSURES

Device: GalaFLEX Scaffold

Use: The FDA does not consider the use of the manufacturer’s device as described in this Publication to be within the cleared indications for use statement. 

Authors and Funding: Galatea Surgical, Inc., a wholly owned subsidiary of Tepha, Inc., provided the funding for the article. Dr. Simon Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr. David Martin is the Chief Scientific Officer of Tepha, Inc. Dr. Arihka Moses is the Founder of Galatea Surgical, Inc.

Risk: Significant risks or safety concerns associated with the use of GalaFLEX Scaffold known to the manufacturer are described in the Instructions for Use.

Poly-4-hydroxybutyrate (P4HB): A new generation of resorbable medical devices for tissue repair and regeneration.

Category: Review
+ More

Simon F. Williams, PhD; Said Rizik, MS; and David P. Martin, PhD

Biomedical Engineering 58(5):1-14.2013

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/23979121

ABSTRACT

Poly-4-hydroxybutyrate (P4HB) is a thermoplastic, linear polyester, produced by recombinant fermentation, that can be converted into a wide range of resorbable medical devices. P4HB fibers are exceptionally strong, and can be designed to provide prolonged strength retention in vivo. In 2007, the FDA cleared a monofilament suture made from P4HB for general soft tissue approximation and/or ligation. Subsequently, surgical mesh devices for hernia repair, tendon and ligament repair, and plastic and reconstructive surgery have been introduced for clinical use. This review describes the unique properties of P4HB, its clinical applications, and potential uses that are under development.

DISCLOSURES

Tepha, Inc., the parent company of Galatea Surgical, Inc., provided the funding for this article. Dr. Simon Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr. David Martin is the Chief Scientific Officer of Tepha, Inc. Said Rizik is an employee of Tepha, Inc.

PHA Applications: Addressing the price performance issue: I. Tissue engineering.

Category: Review
+ More

Simon F Williams, PhD; David P Martin, PhD; Daniel M Horowitz, PhD; and Oliver P Peoples, PhD

International Journal of Biological Macromolecules 25(1-3):111-21.1999

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/10416657

ABSTRACT

This paper describes the development of medical applications for polyhydroxyalkanoates (PHAs), a class of natural polymers with a wide range of thermoplastic properties. Methods are described for preparing PHAs with high purity, modifying these materials to change their surface and degradation properties, and methods for fabricating them into different forms, including tissue engineering scaffolds. Preliminary reports characterizing their in vivo behavior are given, as well as methods for using the natural polymers in tissue engineering applications.

DISCLOSURES

Dr. Simon Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr. David Martin is the Chief Scientific Officer of Tepha, Inc.

Applications of PHAs in Medicine and Pharmacy.

Category: Review
+ More

Simon F. Williams, PhD and David P. Martin, PhD

Biopolymers Online 2005

Link to Publication: https://onlinelibrary.wiley.com/doi/10.1002/3527600035.bpol4004

ABSTRACT

Polyhydroxyalkanoates (PHAs) are a class of naturally occurring polyesters that are produced by a wide variety of different microorganisms (Steinb¸chel,1991). Although they are derived biologically, the structures of these polymers bear a fairly close resemblance to some of the synthetic absorbable polymers currently used in medical applications. Owing to their limited availability, the PHAs have remained largely unexplored, yet these polymers offer an extensive range of properties that extend far beyond those currently offered by their synthetics counter-parts.

DISCLOSURES

Dr. Simon Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr. David Martin is the Chief Scientific Officer of Tepha, Inc.

Medical Applications of Poly-4-Hydroxybutyrate: a strong flexible absorbable biomaterial.

Category: Review
+ More

Simon F. Williams, PhD and David P. Martin, PhD

Biochemical Engineering Journal 16 (2):97-105.2003

Link to Publication: https://www.sciencedirect.com/science/article/abs/pii/S1369703X03000408

ABSTRACT

Poly-4-hydroxybutyrate (P4HB) is being developed as a new absorbable material for implantable medical applications. P4HB promises to open up new opportunities for the development of medical applications by offering a new set of properties that are not currently available. The absorbable biomaterial is strong yet flexible, and degrades in vivo at least in part by a surface erosion process. While the chemical structure of P4HB is similar to that of current absorbable polyesters used in implantable medical products, P4HB is produced by a fermentation process rather than through a chemical synthesis. P4HB is a thermoplastic material that can be processed using standard plastics processing techniques, such as solution casting or melt extrusion.
The strength of P4HB fibers prepared by melt extrusion compare well with that of traditional suturing materials, however, P4HB is typically more flexible. P4HB should find use in a wide variety of medical fields such as cardiovascular, wound healing, orthopedic, drug delivery, and tissue engineering applications. This paper describes some of the basic properties of P4HB and several of its potential applications in medicine.

DISCLOSURES

Dr. Simon Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr. David Martin is the Chief Scientific Officer of Tepha, Inc.

Indications for Use

GalaFLEX, GalaSHAPE 3D and GalaFORM 3D (Galatea scaffolds) are indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate, and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. Galatea scaffold is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. 

Important Safety Information

Possible complications following implantation of Galatea scaffold include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. The safety and product use of Galatea scaffold for patients with hypersensitivities to the antibiotics kanamycin sulfate and tetracycline hydrochloride is unknown. Galatea scaffolds have not been studied for use in breast reconstructive surgeries. The safety and effectiveness of Galatea scaffold in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of Galatea scaffold in pediatric use has not been established. Consult the Galatea scaffold Instructions for Use for complete prescribing information; including its indications for use, warnings and precautions.