MedShape Announces Commercial Launch of the DynaClip Forte® NiTiNOL Bone Fixation System
Robust 4-leg design indicated for Lapidus fusion and other demanding applications
ATLANTA, Sept. 8, 2020 /PRNewswire/ -- MedShape, Inc., the industry leader in orthopedic devices using advanced functional materials, today announced the full commercial launch of the DynaClip Forte® Bone Fixation System. Developed in collaboration with an esteemed team of experienced foot and ankle surgeons, the DynaClip Forte, with its four-leg inline design and superelastic nickel titanium (NiTiNOL) technology, was designed to meet the anatomic and mechanical requirements of certain high load-bearing applications such as 1st tarsometatarsal (Lapidus) fusion. Available in two different sizes, this latest NiTiNOL innovation accompanies the already commercially available DynaClip® Bone Fixation System.
NiTiNOL staples have become an attractive surgical offering for foot and ankle surgeons over plates and screws due to their ease of use and ability to continuously apply compression across the fusion site post-surgery. However, their use has traditionally been limited in certain indications due to their inability to withstand demanding mechanical environments. The DynaClip Forte's patented low profile 4-leg design allows for the implant to rest comfortably on the bone while also providing improved dynamic compression and rotational stability compared with 2-leg staples. Pre-loaded on a low-profile, disposable Inserter, the DynaClip Forte shares several features with its two-leg predecessor including a broad bridge with thicker leg design that eliminates stress concentrations at the corners of the staple providing better strength and fatigue resistence. The device is also accompanied by a single disposable procedure pack that includes all instrumentation compatible with both size offerings, eliminating waste and time during surgery.
"Working with MedShape's team of engineers, we sought to develop a comprehensive staple system that meets all clinical requirements in terms of biomechanical performance, strength, and ease of use," stated John Kwon, MD, lead Surgeon Design Team Member from Harvard Medical. "I am looking forward to implanting the DynaClip Forte in mechanically challenging applications where traditional staples might fail."
The DynaClip Forte builds off the clinical success of the 2-leg DynaClip staple. Launched in 2019, the DynaClip has been used in a variety of applications across the forefoot, midfoot, and hindfoot and can be combined with the DynaClip Forte in procedures where multi-planar fixation is required. Besides Lapidus fusion, the DynaClip Forte has also been successfully implanted in 2nd/3rd TMT, naviculocuneiform, talonavicular, and calcaneocuboid fusion procedures as well as calcaneal ostemotomies. Chris Hyer, DPM (Orthopedic Foot & Ankle in Columbus, OH) was one of the first to implant a DynaClip Forte. According to Dr. Hyer:
"The DynaClip Forte provides a robust, low profile fixation construct with incredible dynamic compression. I have found it to be a great option, especially in Lapidus fusion cases where I'm concerned about having bulky or prominent hardware."
The DynaClip Forte Bone Fixation System represents the latest addition to MedShape's growing NiTiNOL product portfolio. In 2013, the company launched the DynaNail® TTC Fusion System, the only hindfoot intramedullary nail 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 Most recently, the company released the DynaNail Mini® Fusion System for subtalar fusion surgery.
"The launch of DynaClip Forte demonstrates MedShape's continued commitment to provide the most robust dynamic fixation solutions for our orthopaedic surgeons," said Jeremy Blair, Chief Technology Officer at MedShape, Inc. "The Forte plate-like staple takes dynamic fixation to the next level, significantly improving mechanical performance metrics across the board, while maintaining the procedural ease and speed that surgeons come to expect with the DynaClip system. We are extremely excited to add this powerful tool to our surgeons' bag, and to expand on the commercial and clinical successes of our growing DynaClip staple portfolio."
The DynaClip Forte Bone Fixation System is available for full commercial use in the United States.
About MedShape, Inc.
MedShape, Inc. is a privately held medical device company developing and commercializing medical devices that use patented, advanced material technologies to address the demand for improved joint fusion, soft tissue repair and fracture fixation in foot and ankle surgeries. For more information, visit www.medshape.com.
DynaClip, DynaClip Forte, DynaNail, and DynaNail Mini are registered trademarks of MedShape, Inc.
1Steele 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.
2Ford 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.
3Dupont KM, Shibuya N, Bariteau JT. Tibiotalocalcaneal Arthrodesis with Intramedullary Nails – Mechanobiological Background and Evolution of Compressive Technology. Global J of Orthopedics Research, 2019. 1(5): 1-8.
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SOURCE MedShape, Inc.
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