First U.S. Growth Guidance System Cleared to Treat Scoliosis with Children’s Needs in Mind
MEMPHIS, TN – Aug. 28, 2014 – Medtronic, Inc. (NYSE: MDT), today announced the 510(k) clearance and launch of the SHILLA(TM) 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.
The SHILLA(TM) 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.
“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(TM) 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(TM) 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.”
The SHILLA(TM) Growth Guidance 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.
“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(TM) Growth Guidance System to an important patient population as we seek to address universal healthcare needs related to outcomes, costs and patient access.”
Since receiving CE (Conformité Européenne) Mark in 2012, the SHILLA(TM) Growth Guidance System has been used in 17 countries, on 3 continents.
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About the SHILLA(TM) Growth Guidance System
The SHILLA(TM) Growth Guidance System 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 SHILLA(TM) Growth Guidance System is intended to be removed after skeletal maturity. Every spinal surgical procedure involves risks. Patients should consult with their physicians to discuss the potential risks associated with this procedure. Patients need to know that not all spinal surgeries are successful. Adverse events such as implant loosening or breakage may occur, which could result in the need for further surgery.
About Medtronic’s Spinal Business
Medtronic’s spinal business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. Medtronic’s spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art therapies for spinal, neurological, orthopaedic and oral maxillofacial conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about spinal treatments can be found at its patient-education Web site, www.back.com.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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