Williams Simon F, Martin David P, Moses Arikha C
Dr Williams is a Consultant to Tepha, Inc. and a member of the Tepha Board of Directors. Dr Martin is the Chief Scientific Officer of Tepha, Inc. Dr Moses is a Consultant to Tepha, Inc. and is the Founder of Galatea Surgical, Inc. Galatea Surgical, Inc. is a wholly owned subsidiary of Tepha, Inc.
Aesthet Surg J. 2016 Nov;36(suppl 2):S33-S42. doi: 10.1093/asj/sjw141. Epub 2016 Oct 3.
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 post-market clinical studies evaluating the GalaFLEX Scaffold in rhytidectomy and cosmetic 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.
用于整形和重建手术的GalaFLEX支架（Galatea Surgical公司，马萨诸塞州列克星敦）属于由聚-4-羟基丁酸酯（P4HB）制成的新一代软组织增强产品。这个新产品系列的其他成员包括用于软组织对合的MonoMax缝线（德国图（德国图特林根的Aesculap AG公司）、用于肌腱修复的BioFiber支架（明尼苏达州伊登的Tornier公司）以及用于疝气修复的Phasix网片（新泽西州默里山的C.R. Bard公司）。这些完全可吸收的产品都能长时间保持强度，通常在12周时能保持50%至70%的强度，并有助于体内重塑以实现强大、持久的修复。P4HB属于一类天然存在的生物聚合物，由其制成的纤维具有独特的高强度、柔韧性和生物相容性。GalaFLEX支架由高强度、可吸收的P4HB单丝纤维组成。它是一种针织大孔支架，旨在提升、增强和修复软组织。该支架作为新组织生长的晶格，随着纤维吸收，新组织迅速血管化并与相邻组织完全整合。在这篇综述中，我们描述了P4HB的发展、其生产、特性、安全性以及由P4HB制成的器械的生物相容性。还讨论了由P4HB制成的产品的早期临床结果和当前临床应用。对GalaFLEX支架在除皱术和美容隆胸手术中的上市后临床研究结果表明，该支架可以增强提升后的软组织，在一年时面部和颈部能获得持久的手术效果，在隆胸一年后能提供下极稳定性。
