Giltech has won approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for clinical trials of its innovative peripheral nerve repair ‘wrap,’ with the trials expected to begin before the end of the year.
The ‘wrap’ was developed to be used where peripheral nerves require repair due to injury from trauma or disease. This flexible material can be wrapped around the damaged area and fixed with adhesives or sutures and has advantages over existing peripheral nerve repair procedures in that it is very fast, requires less skill than a microsurgical repair and requires no sophisticated microsurgical equipment.
Gillian Watson, Managing Director of Giltech said: “Pre-clinical studies have shown that peripheral nerve repairs performed using the ‘wrap’ are at least as good as suture repairs carried out by specialist micro-surgeons, the present gold standard. The benefit is that these repairs can be carried out by less specialised surgeons in a fraction of the time. That will mean shorter waiting time for peripheral nerve treatment, less time under anaesthetic and a saving in treatment costs.
She added: “This application is just one of the potential uses for the technology and we believe wrap has an important role to play in surgical and clinical practice. We have carried out extensive evaluation of wrap materials for use in soft tissue anti – adhesiogenic applications with significant success.”
The ‘wrap’ is a non woven tissue of Giltech’s Corglaes water soluble glass fibre bonded with a biodegradable binding solution or polymer to produce an easy to handle, non shedding flexible sheet.
It is prepared as a sheet that can be cut to the appropriate size and is very flexible. Where a body vessel, fibre or conduit has been severed, the wrap is placed around the damage site and glued (using tissue adhesive or an adhesive made from the binder medium) or sutured.
The ‘wrap’ is biodegradable, biocompatible and can be used as a controlled release mechanism (e.g. for antimicrobials or trace elements) or temporary structural support. It can also be used to create an ideal tissue engineering substrate and a temporary scaffold for the maintenance and/or delivery of cells and can be used around tissues which have not been severed (tendons, ligaments, nerve crush injuries) where the local environment requires temporary control.
Giltech is a specialist co-development partner that works with customers around the world to help differentiate their products through the creation of bespoke formulations of its biodegradable and controlled release technologies which have broad application across the medical sector.
With over 25 years of expertise, Giltech’s technologies have been used to produce a range of pioneering and market-leading wound care products including Sorbsan® and Arglaes®.
For further information please visit www.giltech.biz