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MedShape Announces Commercial Launch of DynaClip(TM) Bone Staple
ATLANTA, March 5, 2019 /PRNewswire/ -- MedShape, Inc., the industry leader in orthopedic devices using advanced functional materials, today announced the full commercial launch of the DynaClip™ Bone Fixation System. Featuring superelastic nickel titanium (NiTiNOL) technology, the DynaClip represents the next generation in bone stapling by providing both dynamic compression and reliable durability to withstand the demanding loading conditions in the foot and ankle. The system is also provided sterile with consolidated all-disposable instrumentation to improve efficiency during surgery.
NiTiNOL staples have become an attractive surgical offering for foot and ankle surgeons due to their ease of use and ability to continuously apply compression across the fusion site post-surgery. However, current staple designs have either a thin wire shape or a wide bridge with narrow legs that create stress concentrations at the weakest points of the staple. These localized stresses increase the likelihood for implant failure once the patient begins weight-bearing. To address these limitations, the DynaClip's patented design features a broad bridge with a continuous low-profile and thickened legs that evenly distributes stresses across the bridge and away from the implant corners. These features provide higher bending strength and the ability to resist breaking longer under cyclic fatigue compared with competitor staples.1
Alexander Pappas, M.D., with OrthoSC in Myrtle Beach was one early adopter of the DynaClip. "I have been impressed with the DynaClip staple's solid fixation," said Dr. Pappas. "The DynaClip's simple and intuitive instrumentation also allows for a quick implantation."
Along with improved biomechanical performance, the DynaClip system includes disposable instrumentation designed to streamline the procedure and reduce the amount of waste and time in the operating room. Unlike other staple systems that require a different drill guide for each staple size, the DynaClip's Universal Drill Guide is compatible with all size offerings and can also serve as a sizer. The DynaClip staple also comes pre-loaded on a disposable inserter that includes a built-in tamp and features a "Quick-Slide Release" mechanism for a fast, simple delivery method. In the event the surgeon is not satisfied with the position in bone, the DynaClip can be removed and re-positioned using a Re-load Tool. The DynaClip is provided in 9 different sizes, including multiple leg lengths, in order to accommodate all patient anatomy in the forefoot, midfoot, and hindfoot while still maximizing dynamic compression.
Naohiro Shibuya, D.P.M., with Texas A&M College of Medicine was also an initial user of the DynaClip. "The DynaClip's low profile and dynamic compression allows stable fixation very quickly and effectively," said Dr. Shibuya. "It is a no brainer for midfoot fusions where joint surfaces are small and oblique screw fixations are ineffective and time consuming."
The DynaClip represents MedShape's second product offering to feature the company's superelastic NiTiNOL technology. In 2013, the company launched the DynaNailÒ TTC Fusion System, the only hindfoot intramedullary nailing system that can maintain post-operative compression and provide immediate dynamization, thus revolutionizing how surgeons could treat challenging patient populations with severe hindfoot deformities and arthritis.2-3
"We are pleased to continue to leverage our NiTiNOL technology to provide foot and ankle surgeons with smart, innovative devices like the DynaClip," said Kurt Jacobus, Chief Executive Officer of MedShape, Inc. "The DynaClip with its durable design, instrumentation, and numerous size offerings, is an excellent complement to MedShape's growing foot and ankle product portfolio."
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 new material technologies to address the increasing demand for improved joint fusion, soft tissue repair and musculoskeletal trauma products in the foot & ankle. For more information, visit www.medshape.com.
DynaClip is a trademark of MedShape, Inc.
1Data on File, MedShape 2019.
2Ford SE, Kwon JY, Ellington JK. Tibiotalocalcaneal Arthrodesis Utilizing a Titanium Intramedullary Nail With an Internal Pseudoelastic Nitinol Compression Element: A Retrospective Case Series of 33 Patients. Journal of Foot & Ankle Surgery, 2019; DOI: 10.1053/j.jfas.2018.08.046.
3Conklin MJ, Smith KE, Blair, JW, Dupont KM. Total Ankle Replacement Conversion to Tibiotalocalcaneal Arthrodesis With Bulk Femoral Head Allograft and Pseudoelastic Intramedullary Nail Providing Sustained Joint Compression. Foot & Ankle Orthopaedics, 2018; 3(4): 1-7.
SOURCE MedShape Solutions, Inc.