FDA Clears Medtronic SHILLA™ Growth Guidance System

Medtronic, Inc., has gained U.S. FDA 510(k) clearance and will now launch its SHILLA™ Growth Guidance System. The system is designed for treatment of skeletally immature pediatric patients less than 10 years of age diagnosed with severe, progressive, life-threatening, early-onset spinal deformities.

Background

The SHILLA Growth Guidance System is a new growth-sparing technology that allows correction of the deformity while maintaining the corrections over time, minimizing the need for periodic lengthening procedures. This is different than current operative treatments, which are distraction based systems that require lengthening every 6 to 9 months.

The system utilizes a unique non-locking set screw at the proximal and distal portions of the construct’s rods. This specific feature allows the rod to slide through the screw heads as the child’s spine grows, while still providing correction of the spinal deformity. It is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth, who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome. The system is intended to be removed after skeletal maturity.

Medtronic tells us that since receiving CE Mark in 2012, the SHILLA Growth Guidance System has been used in 17 countries, on 3 continents.

Physician comments

“Early onset scoliosis is extremely difficult to treat. The current gold standard technique to manage scoliosis long-term is to fuse the spine, but in children who are still growing this can have serious complications,” explains SHILLA Growth Guidance System inventor Dr. Richard McCarthy, an orthopaedic surgeon and faculty member at the University of Arkansas for Medical Sciences/Arkansas Children’s Hospital. “Until now we were only able to offer operations which use implants to stabilize the curve in the spine, but these frequently mean twice-yearly surgeries as a child grows.  The clearance of the SHILLA Growth Guidance System marks the first time we can offer effective management of the curvature of the spine while still harnessing the child’s natural growth.”

Company comments

“This clearance advances care for children with early-onset spinal deformities, and for their families and caregivers,” said Doug King, vice-president, president of Medtronic Spinal. “We want to thank our surgeon partners and the FDA for helping us bring the SHILLA Growth Guidance System to an important patient population as we seek to address universal healthcare needs related to outcomes, costs and patient access.”

Source: Medtronic, Inc., Image courtesy Medtronic, Inc.

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