Silk solution for biologic bone graft
A new biologic bone graft containing purified silk fibres has received the CE Mark in Europe and Therapeutic Goods Administration (TGA) listing in Australia.
The i-FACTOR Flex FR features synthetic small peptide (P-15) bone graft technology with the addition of purified silk fibres to provide enhanced cohesion, mechanical properties and handling characteristics.
The bone graft is based on original P-15 technology developed by the privately owned company Cerapedics to support bone growth through cell attachment and osteoblast differentiation. Silk from larvae of the Bombyx mori moth is purified to remove the protein sericin, resulting in biocompatible fibroin fibres that enhance cohesion and mechanical properties.
Cerapedics has conducted a limited market release for i-FACTOR Flex FR in order to obtain feedback from surgeons on a range of product enhancements. To date more than 60 procedures have been successfully completed using the bone graft, primarily in spinal fusion applications.
“Based on our clinical experience thus far, [it] appears to offer significant advantages in handling while maintaining the safety and efficacy of the first generation i-FACTOR with P-15 technology,” said Niall Craig, consultant orthopaedic surgeon at NHS Grampian in the United Kingdom.
“The out-of-package handling and in vivo cohesive properties are impressive enhancements and can help improve performance in a number of surgical indications,” added Gregory Kesteloot, a neurosurgeon at Stedelijk Ziekenhuis Roeselare in Belgium.
i-FACTOR biologic bone graft is not currently approved for commercial use in any indication in the USA and is limited by US Federal Law to investigational use only.