Medtronic (NYSE: MDT) received second clearance from the U.S. Food and Drug Administration for its TSRH Spinal System, which treats pediatric adolescent idiopathic scoliosis with posterior pedicle screw instrumentation.
’This additional AIS clearance will further afford Medtronic the ability to provide training and education to spine surgeons treating patients diagnosed with AIS,’ Medtronic Spinal President Doug King stated. ’This clearance also provides an opportunity to further research and study these patients allowing us to move forward with our commitment and investment in pediatric innovation.’
The TSRH Spinal System was first launched in 2009. Medtronic’s spinal revenue of $825 million declined 3 percent, compared to a global market growth of 1 percent and U.S. market decline of about 1 percent. However, Medtronic’s Spinal business grew 7 percent in international markets, according to an earnings call discussing first quarter 2012 results.