MedShape DynaNail Shows Successful Outcomes in High-Risk Patients
First NiTiNOL-based large joint fusion device reaches 100 implantations in limited launch
ATLANTA (January 7, 2014) - MedShape, Inc., the industry leader in innovative shape memory orthopedic devices, today reported on the first wave of clinical outcomes in patients who have received the DynaNail® TTC Fusion System. To date during its targeted soft launch period, DynaNail has been successfully implanted in over 100 tibiotalocalcaneal (TTC) fusion procedures. Because the internal nickel titanium (NiTiNOL) element maintains the target fusion bones in close apposition and under sustained compression, fusions are being observed with the DynaNail TTC Fusion System in high-risk patients, specifically those who require bone allografts.
Since its introduction in October 2012, DynaNail has been used to address numerous pathologies, including Charcot neuroarthropathy, severe ankle and subtalar osteoarthritis, failed total ankle replacement and nonunion following a previous arthrodesis procedure. In many of these patients, a bone allograft was used in combination with DynaNail to fill large bony defects and/or replace a fractured or missing talus. Achieving fusion using an allograft has previously proven challenging, particularly in high-risk patients with degenerative bone conditions or who are immuno-compromised. A 2013 study published in Foot & Ankle International reported a 50% non-union rate in patients who underwent TTC fusion when an allograft was used and no fusions when the graft was used on diabetic patients.1
However, a large number of high-risk patients have experienced fusions with DynaNail, as confirmed by CT scan, including many with bulk allografts. Dr. Thomas San Giovanni of the UHZ Sports Medicine Institute in Coral Gables, Fla. has implanted DynaNail in five patients, using a femoral head allograft for three, with successful fusion in each.
"I believe we may be entering a new era within orthopedics where the unique properties of certain materials such as NiTiNOL will be used to our advantage to assist in the healing of bone - complementing both the mechanical and biologic nature of bone healing," said Dr. San Giovanni. "The DynaNail is the first product of its kind and certainly is on the brink of this technology. I've had very good success with the DynaNail in some of the most difficult clinical scenarios where combined arthrodesis of the ankle and subtalar joint was needed. It has become my preferred fixation method when using a nail for TTC fusions. I have been very impressed by its performance and foresee the technology and unique properties of this nail lending itself to many future applications, even for other conditions."
Dr. Eric Giza at the University of California Davis in Sacramento, Calif., has also used DynaNail in three TTC fusion procedures. In his first case he used a fibular autograft, and for the second case he implanted a synthetic trabecular metal spacer due to severe bone loss. At four months, there is evidence of fusion for both patients while the third patient is still outside the fusion window.
"I have found that the maintenance of compression from DynaNail has led to impressive stability for complex cases," said Dr. Giza.
Likewise, Dr. Troy Watson of the Desert Orthopedic Center in Las Vegas, NV has used the DynaNail in one patient requiring a femoral head allograft.
"The capacity of the DynaNail to sustain compression post-surgery is a unique and critical function in TTC fusions where bone resorption will be significant," said Dr. Watson.
DynaNail is the only TTC fusion device to harness the superelastic properties of NiTiNOL. Its internal NiTiNOL element allows for compression to be maintained across the joint post-operatively by automatically adapting to loading changes due to settling or resorption. In addition, the ultra-low axial stiffness of the NiTiNOL element automatically dynamizes the joint, and mitigates stress-shielding that is universal to all other intramedullary nails on the market. Dr. Samuel Adams from Duke University in Durham, N.C. first used DynaNail based on its sustained compressive power. Dr. Adams has implanted DynaNail in five patients, all using a bone allograft.
"The DynaNail is an unrivaled orthopedic device and my implant of choice for hindfoot arthrodeses," stated Dr. Adams. "No other hindfoot fusion device allows for intraoperative compression and accounts for postoperative bone resorption through sustained dynamic compression. It's amazing to see the DynaNail at work!"
Compression across the joint is important for not only ensuring the bones remain in close apposition, but also in promoting healing. According to Dr. Daniel Latt from the University of Arizona in Tucson, Ariz.,
"The DynaNail is the perfect alternative to a multiplanar external fixator in the treatment of failed hindfoot fusion. It is the only internal device capable of generating continuous compression to stimulate growth of the fusion mass."
Dr. Latt has performed four TTC fusions using DynaNail, all in combination with a cancellous bone allograft. Three patients have shown evidence of fusion at three months post-operation while the fourth patient is still in the early stages of recovery. The DynaNail TTC Fusion System will be available for full release beginning in January 2014.
For more information on DynaNail, please visit www.medshape.com/our-products/dynanail.html .
About MedShape, Inc.:
MedShape, Inc. is a privately held medical device company working to develop and commercialize a portfolio of surgical solutions that use its patented shape memory technologies to address the increasing demand for improved sports medicine, joint fusion, and musculoskeletal trauma products. For more information, visitwww.medshape.com.
1Jeng CL, Campbell JT, Tang EY, Cerrato RA, Myerson MS. Tibiotalocalcaneal Arthrodesis with Bulk Femoral Head Allograft for Salvage of Large Defects in the Ankle. Foot and Ankle International, 2013. 34: 1256-1266.
DynaNail is a registered trademark of MedShape, Inc.