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MedShape Announces First Clinical Use of the DynaNail® XL

Wednesday, January 31, 2018

MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that the first surgeries using the DynaNail® XL TTC Fusion System were successfully performed. The DynaNail XL represents the longer counterpart to the already commercially available DynaNail, the only internal fixation system that uses patented superelastic nickel titanium (NiTiNOL) technology to maintain post-operative active compression like an external fixator and offer immediate dynamization. These surgeries also coincide with the introduction of the new Quick Compress Technique that greatly simplifies the surgical steps needed to implant a DynaNail.

Tibiotalocalcaneal (TTC) fusions are often considered a salvage procedure as a last surgical attempt before amputation to restore hindfoot alignment and relieve pain. In most instances, the patient has undergone one or multiple failed surgical procedures and might have a weakened tibia due to fracture or screw holes. Available in 260 mm and 300 mm lengths, the DynaNail XL, with its internal NiTiNOL Element, provides a fusion option to surgeons that better accommodates longer patient tibial anatomies and potentially reduces stress risers in the bone, consequently lowering the occurrence for tibial fractures.1 DynaNail XL features a similar design to the original 220 mm version including an internal NiTiNOL Element, but also has a proximal taper to facilitate easy insertion through the tibial isthmus and an optional proximal tibial screw for additional stability. Gregory Neely, MD, an orthopaedic foot and ankle surgeon with Sanford Health in Sioux Falls, SD, was one of the first surgeons to implant a DynaNail XL.

"I am excited to have the DynaNail XL available as an option for my TTC fusion surgeries.  The variability in size without changing technique or set up in the operating room expands this product's utility.  I am pleased with the outcomes from my first XL patient so far," said Dr. Neely. "The original DynaNail's post-operative compression capabilities have always given me confidence that I can achieve fusion in even the most challenging hindfoot cases. Now with the variable length offerings, I can apply this unique technology to more of my patient population including those with post-traumatic deformity, previous hardware stress risers, and individuals with a larger frame where increasing the working length of the device likely improves stability."

In concert with the launch of the DynaNail XL, MedShape also introduced the Quick Compress Technique, a streamlined surgical approach that can be used as a substitute to the standard technique. Because the DynaNail is able to maintain compression for up to 6 mm of resorption or settling, a surgeon can bypass manual compression with the Quick Compress technique, thereby eliminating surgical steps and reducing OR time. The new technique also offers the option of continued dynamization once the NiTiNOL Element has fully recovered.

"The Quick Compress Technique using the DynaNail has become my go-to surgical technique for TTC fusions," said Kent Ellington, MD from OrthoCarolina Foot & Ankle Institute in Charlotte, NC. "I am able to save valuable surgery time while still achieving active compression across the joints during the healing process."

The release of the DynaNail XL and Quick Compress Technique follows several updates to the product line in 2017, including the launch of the new DynaFrame™ Carbon-Fiber Targeting System, updates to instrumentation, and the release of additional instrument sets to accommodate the rapidly growing demand. To date, the DynaNail has demonstrated clinical success in revision TTC surgeries and in patients with large bony defects or who are diabetic or chronic smokers.2,3,4