Memphis-based Solana Surgical, LLC has been cleared by the FDA to market its CrossCheck plating system used by orthopedic and podiatric surgeons in foot and ankle procedures. The company expects to begin commercializing the product in the first quarter of 2014.
Solana Cleared for Foot and Ankle Plating System
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According to a December 20, 2013 company announcement, the first phase of commercialization will include plates that will be primarily used for stabilization and fixation (leading to fusion) in the forefoot and mid-foot. Fusion is often the procedure used to relieve pain and correct skeletal alignment issues in patients with arthritis, as well as small joint fractures and bunions.
The company says its system is unlike other plating systems on the market because it offers “unique compression and stabilization features: the plates are manufactured with a Type II anodization, which enhances the fatigue strength of the device, and thus improves stabilization.” Additionally, the company’s specially designed ridges are built into the plates to enhance grip, and act as a buttress during the compression process. “Studies have shown that similar ridges can also improve host bone health, ” explains Rebecca Wahl, vice president of Research and Development.
The system offers various sizes and configurations for specific surgical needs and is added to the company’s family of products that include a fixation system, TenFuse PIP with sterile instruments, a nail, screw system, a metatarsal decompression implant, a lesser metatarsal head implant, acellular dermal tissue, a cancellous sponge, moldable putty and the Gaitway implant system.
The privately held company was founded in 2008 by former extremity company executives and launched its first product in 2011. In addition to Wahl, current employees include: Alan Taylor, the company’s president and CEO; Tommy Turpin, senior vice president of operations and regulatory affairs and Jon Simon, vice president of sales and marketing.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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