FDA Clears Longer DynaNail
Walter Eisner • Mon, November 20th, 2017
MedShape, Inc.'s DynaNail XL TTC Fusion System has received FDA 510(k) clearance for patient use in the U.S.
The additional clearance expands the product's use to patients with longer tibial anatomies or who have undergone prior failed fusion procedures using an intramedullary nail (IM), according to a November 14, 2017 company press release. The new lengths are now available in 260mm and 300mm lengths.
The company says, indicated for tibiotalocalcaneal (TTC) fusion surgery, the new lengths were developed in response to surgeon demand for an IM nail that better accommodates longer patient tibial anatomies or when tibial fractures are present. "Its longer length in combination with DynaNail's pseudoelastic NiTiNOL Element could help reduce stress risers in the bone, consequently lowering the chance for tibial fractures.”
The new nail “features a similar design as the original 220mm version but, according to the company, also has a proximal taper for easy insertion through the tibial isthmus and an extra proximal screw hole for an optional cortical screw for additional stability.”
The DynaNail was introduced clinically in 2012. The company claims it is the "first and only internal fusion device to harness the pseudoelastic properties of NiTiNOL (nickel titanium) to provide the compression performance of an external frame inside an IM nail design. Compression, says the company, has shown to be important not only in keeping the bones in close apposition but also in providing the physiological stresses needed to promote bone healing.”
The device’s compressive element maintains post-operative compression for up to 6mm of bone resorption and settling. The company provided evidence that the “…compressive element also allows for effective load sharing across the bone due to its axial compliance during weight-bearing. To date, the DynaNail has demonstrated clinical success in revision TTC surgeries and in patients with large bony defects or who are diabetic.”
According to the FDA database it took the agency about six months to make a decision about clearance. The DynaNail XL will be launched in early 2018.