Officials at MedShape Inc. introduce the first surgical use of the DynaNail Ankle Arthrodesis Nail, an intramedullary (IM) nail that contains an innovative internal nickel titanium (NiTiNOL) element. The product represents a breakthrough in that it is the first IM nail to harness the shape memory properties of NiTiNOL, which up to now has been impeded from clinical use due to various technological challenges ranging from basic materials science to manufacturing and device design.
After receiving 510(k) clearance from the U.S. Food and Drug Administration, DynaNail was successfully used in an ankle arthrodesis procedure performed by Dr. Doug Pacaccio, DPM, at Valley West Community Hospital in Chicago, IL.
"I was impressed with the performance of the DynaNail device," says Dr. Pacaccio, who is a co-founder of MedShape. "The nail sustains compression across the joint like an external fixator, but because it is inserted like traditional IM nails, it reduces operating time significantly."
DynaNail is expected to become an effective alternative to external fixators for treating limb salvage procedures, as the NiTiNOL compressive element gives the nail unique properties over traditional IM nails. Compression across the joint is important for not only ensuring the joint bones remain in close apposition, but also in promoting healing.
"The NiTiNOL compressive element allows DynaNail the ability to apply sustained compression across the joint on the level of an external fixator. Traditional nails lose compression upon hardware removal or require follow-up procedures to re-apply compression," says Jeremy Blair, team leader for DynaNail. "NiTiNOL gives DynaNail 'shape memory' so that it can automatically transform and adapt to bone resorption minimizing the need for follow-up procedures."