Ir al contenido
The information contained in this website is intended for International Health Care Professionals. Patients, please refer to your physician for information.
  • About Us
    • Brand History
    • History of P4HB
  • What is GalaFLEX?
    • Instructions for Use
    • What is P4HB?
    • Properties
    • The Scaffold Collection
      • GalaFLEX®
      • GalaFLEX 3D TM
      • GalaFLEX 3DR TM
    • Information for your patient
  • Publications
  • Contact Us
    • Locations
Menú
  • About Us
    • Brand History
    • History of P4HB
  • What is GalaFLEX?
    • Instructions for Use
    • What is P4HB?
    • Properties
    • The Scaffold Collection
      • GalaFLEX®
      • GalaFLEX 3D TM
      • GalaFLEX 3DR TM
    • Information for your patient
  • Publications
  • Contact Us
    • Locations
The information contained in this website is intended for International Health Care Professionals. Patients, please refer to your physician for information.

Publications

The History of GalaFLEX P4HB Scaffold

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

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 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.

Downloaded from http://asj.oxfordjournals.org/ by guest on October 5, 2016

  • Home
  • About Us
  • What is GalaFLEX?
  • Publications
  • Contact
Menú
  • Home
  • About Us
  • What is GalaFLEX?
  • Publications
  • Contact

See instructions for use here

+ Show References
+ Show patents
Twitter Instagram Linkedin Facebook
Galatea Surgical© 2023. All Rights reserved 500075 Rev B
  • Terms of Use
  • Privacy Policy
Menú
  • Terms of Use
  • Privacy Policy
+ Show References
+ Show patents
Twitter Instagram Linkedin Facebook
Galatea Surgical© 2023. All Rights reserved 500075 Rev DB
  • Terms of Use
  • Privacy Policy
  • Terms of Use
  • Privacy Policy
Important Cookie Information – This message will only appear once. Galatea Surgical website uses cookies. By continuing to browse the site, you are agreeing to the use of cookies.
Read Privacy Policy ACCEPT
Manage consent

Privacy Overview

Read Privacy Policy

Necessary
Siempre activado
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Non-necessary
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.
GUARDAR Y ACEPTAR
The information contained in this website is intended for International Health Care Professionals. Patients, please refer to your physician for information.
  • Home
  • About Us
  • What is GalaFLEX?
  • Publications
  • Contact
  • Home
  • About Us
  • What is GalaFLEX?
  • Publications
  • Contact