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MedShape DynaNail Shows Successful Outcomes in High-Risk Patients
Date:1/7/2014

ATLANTA, Jan. 7, 2014 /PRNewswire/ -- 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.

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SOURCE MedShape, Inc.
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