MedShape today said it received a $2.6 million grant from the U.S. Department of Defense Peer-Reviewed Medical Research Program (PRMRP) to research nickel-titanium for diabetic foot limb salvage surgery.
The research grant will assist in the development of a dynamic compression-fusion device using superplastic nickel-titanium (nitinol) for use in diabetic foot limb salvage surgery. The award of $2.6 million will be available over the next 3 years.
According to the company, nearly 5 million military veterans suffer from diabetes mellitus with 15,000 also diagnosed with Charcot foot, a condition causing weakening of foot bones that can occur in people who have significant nerve damage (neuropathy). Orthopedic surgeons have a goal of salvaging the limb with alternative surgical treatments where intramedullary screws are placed across the midfoot in an attempt to stabilize and realign the foot.
Through the research grant, MedShape will explore the development of devices that maintain dynamic compression and effectively stabilize the foot in an effort to preserve the limb in the diabetic Charcot veteran population. MedShape’s patented nitinol platform can help design devices to adapt and respond to specific changes in a biological environment that occur during healing while also lead-sharing with the bone to reduce stress risers on the device, according to the company.
“Standard midfoot fusion devices should be robust enough to withstand weight-bearing and also able to apply compression for bone-on-bone healing. However, standard devices don’t work well for diabetic patients with Charcot neuroarthropathy because their midfoot bones have deteriorated, which puts them at risk for amputation. Surgeons need a better solution, and we believe that our dynamic compression technology can be developed to address this dire need,” David Safranski, director of basic research at MedShape, said in a news release. “Due to MedShape’s extensive experience in smart (nitinol-based) orthopedic devices, we are uniquely qualified to address this clinical challenge with our veterans. The PRMRP’s support is critical for our team to develop these next-generation medical devices.”
MedShape said that its nitinol technology has already been successfully demonstrated through its DynaNail TTC fusion system.