Researchers help get backing for device that could revolutionise bone and tendon repair
A new suture device for common strain and stress injuries was approved by medical bodies, following evidence provided by researchers at Manchester Metropolitan University.
Smith and Nephew is a global medical devices company that operates in 90 countries. It had developed a new suture device for strain and stress injuries, which it wanted to get approved by regulatory bodies.
Strain and stress injuries linked to bone and tissue are common among athletes and older people. Full repair of these injuries can be difficult, as it can be hard to get the joint to regain full strength.
Currently, clinicians use rotator cuff repair surgery for these injuries. The main aim of this is to re-join tissue to start the repair process.
An estimated 950,000 rotator cuff repair procedures occur word-wide. However, up to 95% of these injuries are re-tears, meaning that they will not heal. While certain products have attempted to address the issue (such as double-row fixation and platelet rich plasma), none have proved to be clinically effective.
Smith and Nephew believed their new device was more effective than other procedures used in current practice. The company needed to compile evidence to present to medical regulatory bodies in order for it be approved for use.
The suture-based device, called Ultrabraid Plus suture, brings tissue together so that it can be sutured. It differs from conventional devices in its use of sodium butyrate – a compound that enhances soft tissue repair.
Professor Mark Slevin from the University and his team provided Smith and Nephew with rigorously researched evidence showing the device:
The project ran for three years, collated evidence under these three areas, and took the project from idea all the way through to proof of concept. Prior to Manchester Met’s involvement, there was no evidence as to whether the sodium butyrate was effective in wound healing.
Smith and Nephew relied heavily on the evidence that Manchester Metropolitan University provided to get the product approved by the Food and Drug Administration (FDA) and the Medicines and Health Regulatory Authority (MHRA).
“We valued the expertise and research value the team offered in helping us get this innovative product closer to the market.”
Nick Cotton, Scientific Fellow at Smith and Nephew, said: “The research and consultancy work that Mark and his team provided were instrumental in helping us get this product through to clinical trials. We valued the expertise and research value the team offered in helping us get this innovative product closer to the market.”
“Manchester Metropolitan University has the capacity, expertise and capability to work with very large companies”
Professor Mark Slevin said: “This project demonstrates that Manchester Metropolitan University has the capacity, expertise and capability to work with very large companies, assisting them with product development towards clinical trials and impact in healthcare. It shows that Manchester Met is working at an elite, world-class level when it comes to consultancy in healthcare.”