NuVasive, Inc. has won 510(k) clearance to market a magnetic technology and adjustable growth rods to treat early-onset scoliosis.
FDA Clears NuVasive Early-Onset Scoliosis Treatment Implants
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Early-onset of scoliosis used to be a sentence of possible endless surgeries to straighten out the spine. Then came growing-rod surgical and genetic solutions to predict curvature growth and apply appropriate interventions. But with 72% of complications in growing-rod surgery for early-onset scoliosis being due to implant related failures, there was room for improvement.
On September 6, 2017, NuVasive, Inc. said the FDA gave the company 510(k) clearance to unite its RELINE Small Stature fixation portfolio with the MAGEC System.
Matt Link, the company’s executive vice president of strategy, technology and corporate development stated, “As a low-profile pediatric fixation system, RELINE Small Stature is the first-of-its-kind system to offer competitively-sized pediatric implants that accept up to a 5.0mm rod. The clearance for our redesigned MAGEC system with RELINE Small Stature highlights our speed to market and our further commitment to bringing procedural solutions that transform care to the pediatric deformity market.”
The system is also cost-neutral to traditional growing rod treatment, states the company.
MAGEC
According to the company, the MAGEC system includes redesigned components, which helps provide ease-of-use for the surgeon and help make surgical outcomes more reproducible. The redesign also introduces a 5.0mm rod diameter offering. The company added that patients receive the same benefits found in traditional growing rod treatment with the added benefit of noninvasive distractions. Planned distractions take place in an office setting and are generally quick and painless.
Michael Vitale, M.D., Chief, Pediatric Spine and Scoliosis Surgery at Columbia University said, “With the elimination of additional planned distraction surgeries, the MAGEC system helps simplify care for this patient population like no other technology.”
RELINE
RELINE Small Stature is a comprehensive pediatric deformity fixation system which seeks to achieve optimal construct strength with a reduced implant profile. It is the only small stature system that is compatible with the new 5.0mm MAGEC rod.
Last October, NuVasive said it won expanded FDA clearance for the MAGEC system, indicated for safe use with 1.5 tesla magnetic resonance imaging devices.
NuVasive featured the new combo at the Scoliosis Research Society (SRS) 52nd Annual Meeting & Course held September 6-9, 2017 in Philadelphia, Pennsylvania.
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Discussion
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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