European Commission clears Medtronic growth guidance system

30 May 2012 (Last Updated May 30th, 2012 18:30)

Medtronic has received a CE Mark for its Shilla growth guidance system designed to treat early-onset scoliosis (EOS), a curvature of the spine that can occur in the paediatric population before the age of five.

Medtronic

Medtronic has received a CE Mark for its Shilla growth guidance system designed to treat early-onset scoliosis (EOS), a curvature of the spine that can occur in the paediatric population before the age of five.

The Shilla growth guidance system is a rod and screw based system consisting of a flanged set screw designed to capture the rod, while allowing it to slide as the patient grows.

The company's growth guidance system is indicated for the correction and maintenance of multi-planar spinal deformities associated with patients with severe, progressive, life-threatening EOS associated with thoracic insufficiency and spinal growth insufficiency that requires surgical treatment before ten years of age.

Professor Richard McCarthy, orthopaedic surgeon at the University of Arkansas for Medical Sciences and Arkansas Children's Hospital, said the current standard technique to manage scoliosis long-term is to fuse the spine, but in children who are still growing this can have serious complications.

"Until now we were only able to offer operations which use implants to stabilise the curve in the spine, but these can mean twice yearly surgery as a child grows," McCarthy added.

"Shilla is the first time we can offer an effective management for the curvature of the spine which grows with these young patients."

Medtronic Spinal and Biologics Western Europe and Canada vice-president, Steve Swinson, said the company has worked closely with Professor McCarthy to make Shilla available in Europe.

"It is a genuine advance, which means these severely ill children now have a new surgical option which can minimise the amount of secondary surgeries required which have the risk of pain, complications and more anaesthesia," Swinson added.


Image: Medtronic World Headquarters, Fridley, Minnesota, US. Photo courtesy of: Bobak Ha'Eri.