MedShape Announces Commercial Launch of DynaNail Mini® for Medial Column Fusion

ATLANTA, Dec. 8, 2020 /PRNewswire/ -- MedShape, Inc., the industry leader in orthopedic devices using advanced functional materials, announced today the full market release of the DynaNail Mini^® Fusion System for medial column fusion to address Charcot Foot and other severe midfoot conditions. Featuring MedShape's patented superelastic nickel titanium (NiTiNOL) technology, the DynaNail Mini is the first internal fixation device designed specifically for medial column fusion that offers maintained active compression post-surgery to promote bone healing and joint stability. Originally launched in 2019 in 60- 100 mm lengths for use in subtalar fusion procedures, this latest version is now offered in longer lengths (110-140 mm) to allow for more stability and post-operative NiTiNOL compression across the midfoot bone anatomy.

Midfoot reconstruction represents a significant clinical challenge for orthopaedic surgeons, particularly in Charcot neuropathic patients given the compromised bone healing-capacity and poor bone quality inherent to the condition. Internal beaming devices are often used in surgery to fixate the corrected deformity and promote fusion. However, current beaming devices lose compression post-surgery and have a high propensity to break or migrate resulting in high reported nonunion, complication rates,¹ and in some instances amputation. In contrast, the DynaNail Mini with its internal NiTiNOL Element can maintain up to 6 mm of post-operative compression in response to bone resorption or settling.² NiTiNOL has shown to be advantageous in applications where dynamic compression is required to actively promote bone healing of a fusion site. The increased elasticity of the NiTiNOL Element also enables better load-sharing to the bone, thereby reducing any stress risers in the device that can increase the risk of implant failure post-surgery.

Under a limited market release since 2019, the DynaNail Mini has been successfully implanted in a number of medial column fusion procedures by a select group of leading foot and ankle surgeons across the country. According to Kent Ellington, MD (OrthoCarolina Foot & Ankle Institute, Charlotte, NC), one of the first surgeons to implant the DynaNail Mini in a medial column fusion:  

"I use the DynaNail Mini for medial column fusion with my most challenging patients–including those with Charcot neuroarthropathy. Patients that are now a year post-surgery have achieved successful union, maintained alignment without additional hardware, and are doing well. I attribute my clinical success to the post-operative compression that the NiTiNOL Element in the DynaNail Mini provides and the overall strength of the nail. It helps facilitate healing in a way that you just do not see with static beaming devices. The system is easy to use and provides strength, maintains reduction, and provides post-operative compression…win, win, win!"

The DynaNail Mini represents the latest innovation in the DynaNail product line to feature an internal NiTiNOL Compressive Element. The company first released the DynaNail^® TTC Fusion System in 2013, the first intramedullary nail that offered maintained active compression for hindfoot fusion. The device is now supported by numerous peer-reviewed clinical publications demonstrating faster fusion time at higher fusion rates when treating high-risk patient populations such as those with Charcot ankle neuropathy.^3,4

"This new version of the DynaNail Mini signifies a major milestone in further expanding MedShape's NiTiNOL nail technology beyond the hindfoot into other foot and ankle and trauma applications including midfoot," said Kurt Jacobus, chief executive officer of MedShape, Inc. "We have been pleased with the clinical performance of the DynaNail Mini so far and are excited to offer another surgical solution for limb salvage to orthopaedic surgeons."

About MedShape, Inc.

MedShape, Inc. is a privately held medical device company developing and commercializing a portfolio of medical devices that use patented advanced material technologies to address the demand for improved joint fusion, fracture fixation and soft tissue repair in foot & ankle and trauma indications. For more information, visit www.medshape.com.

DynaNail and DynaNail Mini are registered trademarks of MedShape, Inc.

¹Ford SE, Cohen BE, Davis WH, Jones CP. Clinical Outcomes and Complications of Midfoot Charcot Reconstruction with Intramedullary Beaming. Foot & Ankle Int, 2018. 40(1): 18-23.

²Data on File. MedShape, Inc., 2020.

³Ford SE, Kwon JY, Ellington K. Tibiotalocalcaneal Arthrodesis Utilizing a Titanium Intramedullary Nail With an Internal Pseudoelastic Nitinol Compression Element: A Retrospective Case Series of 33 Patients. J Foot Ankle Surg, 2019. 58(2): 266-272. .

⁴Steele JR, Easley ME, Nunley JA, Adams SB, et al. Comparison of Tibiotalocalcaneal Arthrodeses Using a Sustained Dynamic Compression Nail Versus Nondynamized Nails. Foot & Ankle Spec, 2020. 13(3): 193-200

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Company Contact:

Kristel Rodriguez Peacock
601.323.4732
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SOURCE MedShape, Inc.