ATLANTA (July 11, 2017) – MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, today announced the launch of the new DynaFrame™ CF (Carbon Fiber) Deployment System. Manufactured out of carbon fiber-filled polyetheretherketone (PEEK), the DynaFrame CF Deployment System facilitates a simple, reliable method for implanting the DynaNail® TTC Fusion System during surgery. As part of the DynaFrame CF launch, additional DynaNail instrument sets have been released to accommodate the rapidly growing demand for DynaNail. MedShape will be showcasing DynaNail and DynaFrame CF this week at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting in Seattle, WA (Booth #631).
Clinically introduced in 2012, the DynaNail TTC Fusion System is the first and only internal fusion device to harness the pseudoelastic properties of NiTiNOL to offer the compression performance of an external fixator inside an intramedullary (IM) nail design. Compression has shown to be important in not only keeping the bones in close apposition but also in providing the physiological stresses needed to promote bone healing. DynaNail’s internal NiTiNOL Compressive Element maintains post-operative compression by automatically adapting for up to 6 mm of bone resorption or settling. During surgery, DynaFrame CF is used to insert DynaNail and stretch the NiTiNOL Compressive Element. Once stretched, DynaFrame CF aids in targeting and placing fixation screws across the DynaNail Implant. The Compressive Element is then activated upon removal of DynaFrame CF.
The DynaFrame CF Deployment System is equipped with several new features from the original DynaNail Targeting Frame. In particular, the carbon fiber PEEK construction provides up to 18X more rigidity than the original PEEK material. Several geometry changes were also implemented including adding more clearance to the distal end of the DynaFrame and its posterior-anterior Targeting Arm to accommodate larger patient anatomies. The increased rigidity from the carbon fiber material along with these additional geometry changes eliminates any issues with drill targeting ensuring a fast, simple procedure every time.
“The release of the DynaFrame CF Deployment System represents an important milestone in DynaNail’s commercial progression,” said Jeremy Blair, MedShape Vice President of Research and Development. “Based on surgeon feedback, we recognized the need for a deployment system that reduces the number of surgical pearls, more reliably targets the drills, and was versatile for all patient populations. DynaFrame CF addresses these surgical needs with its robust design and carbon fiber material. With these instrumentation updates, the DynaNail TTC Fusion System now pairs intra-operative simplicity and speed with the already unrivaled clinical benefits of the DynaNail implant.”
Indicated for use in tibiotalocalcaneal (TTC) fusion surgery, DynaNail has become an effective treatment option to address numerous pathologies, including Charcot neuroarthropathy, severe osteoarthritis, failed total ankle replacement and nonunion from previous arthrodesis procedures. While reported non-union rates with static IM nails are as high as 50%,1 DynaNail has demonstrated clinical success in even high-risk patients with poor healing capacity including diabetics and smokers.2,3
“I am pleased with the new DynaFrame and its ease of use during surgery,” said John Kwon MD, Harvard Medical. “I have implanted many DynaNail devices and have been impressed with my patient outcomes to date. DynaNail gives me the confidence that even my most complex patients will receive the compression needed to achieve successful fusion.”
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 for foot and ankle and trauma surgeons that use its patented advanced material technologies. For more information, visit: www.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.
2Latt LD, Dupont KM, Smith KE. Revision Tibiotalocalcaneal Arthrodesis with a Pseudoelastic Intramedullary Nail – A Case Study. Foot and Ankle Specialist, 2017; 10(1): 75-81.
3Hsu AR, Ellington JK, Adams SB, Jr. Tibiotalocalcaneal Arthrodesis Using a NiTiNOL Intramedullary Hindfoot Nail. Foot and Ankle Specialist, 2015; 8(5): 389-96.
DynaNail is a registered trademark of MedShape, Inc.
Kathryn Smith, Ph.D.