The MAGEC System for Spinal Lengthening in Children with Scoliosis: A NICE Medical Technology Guidance

Abstract

Scoliosis—structural lateral curvature of the spine—affects around four children per 1,000. The MAGEC system comprises a magnetically distractible spinal rod implant and an external remote controller, which lengthens the rod; this system avoids repeated surgical lengthening. Rod implants brace the spine internally and are lengthened as the child grows, preventing worsening of scoliosis and delaying the need for spinal fusion. The Medical Technologies Advisory Committee at the National Institute for Health and Care Excellence (NICE) selected the MAGEC system for evaluation in a NICE medical technologies guidance. Six studies were identified by the sponsor (Ellipse Technologies Inc.) as being relevant to the decision problem. Meta-analysis was used to compare the clinical evidence results with those of one conventional growth rod study, and equal efficacy of the two devices was concluded. The key weakness was selection of a single comparator study. The External Assessment Centre (EAC) identified 16 conventional growth rod studies and undertook meta-analyses of relevant outcomes. Its critique highlighted limitations around study heterogeneity and variations in baseline characteristics and follow-up duration, precluding the ability to draw firm conclusions. The sponsor constructed a de novo costing model showing that MAGEC rods generated cost savings of £9,946 per patient after 6 years, compared with conventional rods. The EAC critiqued and updated the model structure and inputs, calculating robust cost savings of £12,077 per patient with MAGEC rods compared with conventional rods over 6 years. The year of valuation was 2012. NICE issued a positive recommendation as supported by the evidence (Medical Technologies Guidance 18).

Analysing a mechanism of failure in retrieved magnetically controlled spinal rods

“…The most current update from National Institute of Health and Care Excellence (NICE) states that there have been only two alterations to the original design of the MCGR [9]; in 2010, the addition of a keeper plate to prevent the internal magnet from rotating, and in 2012, the A recent 4 year follow-up mentioned the company's intention to increase the pin's diameter [15]. However, we could not find any design updates regarding the shielding of the internal mechanism from fluid ingress.…”

“…MCGRs are gaining in popularity among patients and surgeons as they are the least invasive technique for patients with a high degree scoliosis [6][7][8][9][10][11], both for primary operations and conversion cases from the traditional growing rods [12]. Once implanted (see Fig.…”

Management of progressive late onset scoliosis with magnetic growth rod insertion leading to improvement of neural anomalies—a case report

“…The literature describes advantages of magnetic growth rods (MGR) compared with conventional growing rods, especially the avoidance of repeated surgical lengthening procedures, in the safe and effective treatment of early and late onset scoliosis (2,3). The Magnetic rods are also deemed to be cost effective (4).…”

Safety and compatibility of magnetic-controlled growing rods and magnetic resonance imaging

“…Their implantation is supported following a clinical and economical evaluation by the National Institute of Clinical Excellence in the United Kingdom as part of an evidence medical technologies guidance. [14].…”