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Licensed Unlicensed Requires Authentication Published by De Gruyter June 12, 2013

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

  • Simon F. Williams , Said Rizk and David P. Martin EMAIL logo

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.


Corresponding author: David P. Martin, Tepha, Inc., 99 Hayden Ave, Lexington, MA 02421, USA, Phone: +1 781 357 1702, E-mail:

Potential conflicts of interest: The authors (DPM, SR, and SFW) are employed by Tepha. Inc., the manufacturer of poly-4-hydroxybutyrate (P4HB), also known as TephaFLEX biopolymer.

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Received: 2013-1-24
Accepted: 2013-5-13
Published Online: 2013-06-12
Published in Print: 2013-10-01

©2013 by Walter de Gruyter Berlin Boston

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