Ellipse has received FDA 510(k) clearance to market a second, shorter 70mm actuator as part of the MAGEC (Magnetic expansion control) spinal bracing and distraction system. During the same week, the company marked its 100th MAGEC surgery since its limited market introduction in the USA in April. A company press release reports that the MAGEC system provides a unique alternative to the traditional treatment regimen using growing rods which require repetitive invasive lengthening surgeries for early onset scoliosis care.
The press release adds that MAGEC presents a compelling clinical option compared to “growth-guided” systems that require fusions at multiple levels which limit the patient’s ultimate growth potential. The MAGEC system is the only non-invasive, distraction-based system available worldwide for these young patients.
The addition of the 70mm actuator implant enables broader application of the MAGEC system for patients with limited spinal space attributed to severe spinal deformities. This device features a 20% reduction in the length of the existing MAGEC 90 mm actuator, providing surgeons better rod contouring capabilities during surgical procedures. It is estimated that this may enable a 15–20% increase in the number of patients that may benefit from the MAGEC system.
“Paediatric spinal deformity surgeons fully recognize the game-changing benefits of the MAGEC system in eliminating the emotional and painful treatment associated with traditional growing rods,” states Behrooz Akbarnia, clinical professor of Orthopedic Surgery at the University of California, San Diego. “Furthermore, as shown by several multicentre studies, distraction-based systems have the advantage of providing superior growth potential over growth-guided options.”
News of the FDA clearance and the enthusiastic adoption of MAGEC at initial centres in the USA follows the recent published guidance of the UK’s NICE organisation, which broadly approved its use based upon both its efficacy and cost-effectiveness.
To date, the MAGEC system has been used by more than 200 surgeons in 27 countries in more than 1500 surgical procedures.