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
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.
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.