Medtronic has 510 (k) clearance for SHILLA Growth Guidance System to treat Spinal Deformities,
Medtronic, Inc. has announced the 510(k) clearance and launch of the 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 (Scoliosis).
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.
Since receiving CE (Conformit� Europ�enne) Mark in 2012, the SHILLA Growth Guidance System has been used in 17 countries, on 3 continents.
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