US FDA clears Nuvasive’s redesigned Magec system

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Nuvasive logoNuVasive has received 510(k) clearance from the US Food and Drug Administration (FDA) for use of the company’s redesigned Magec system with its Reline Small Stature system. The products were featured at the Scoliosis Research Society Annual Meeting (SRS; 6–9 September, Philadelphia, USA).

The Magec system uses magnetic technology within adjustable growing rods to treat early-onset scoliosis in a less invasive manner. Developments system include redesigned components to help provide ease-of-use and outcomes reproducibility.

In addition, NuVasive is introducing a new 5mm rod diameter offering for the device. When paired with the low-profile Reline Small Stature system, it is designed to provide optimal strength to growing-rod constructs to help improve clinical outcomes.

Reline Small Stature is a comprehensive paediatric deformity fixation system designed to achieve optimal construct strength with a reduced implant profile. Reline Small Stature is the only small stature system that is compatible with the 5mm Magec rod.

Behrooz Akbarnia (San Diego, USA) spoke to Spinal News International about the development of the Magec system and its potential benefits at NSpine (12–15 June; London, UK). He called the device “a game-changer for early onset scoliosis.”

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