New Indication for DePuy Synthes’ Spine Devices Cleared by FDA
DePuy Synthes Spine, a Johnson & Johnson (JNJ) division, has received a U.S. Food and Drug Administration (FDA) 510(k) clearance for its Expedium, Viper, and Viper 2 Spine Systems for patients with adolescent idiopathic scoliosis (AIS), an abnormal curvature of the spine that typically affects children between the ages of 10 and 18. This expands the scoliosis indication for the pedicle screw systems, which now are indicated for both adolescents and adults.
“This FDA clearance is an important milestone for us as a company, and is also important for adolescent patients who will have greater access to the latest technology available if they require spine surgery for their scoliosis,” said Namal Nawana, president of DePuy Synthes Spine worldwide. “DePuy Synthes Spine remains committed to developing innovative technologies for adolescents with scoliosis.”
The Expedium technology was first introduced in 2004. The Viper and Viper 2 Spine Systems have been used in minimally invasive spine surgery for a wide range of pathologies since 2005 and 2008 respectively.
The Expedium system has the lowest profile in the DePuy Synthes’ thoracolumbar portfolio, and is therefore claimed to be a useful option for cases in which the surgeon is challenged with implant protrusion and cosmetic problems, according to the company. It is a rod and screw system for extreme curvatures. The Viper systems comprise of a range of instrumentation and implant options, and are based on the Expedium platform.
The new indication received last month clears the way for the devices to be used in posterior non-cervical pedicle screw fixation in adolescent patients and for the company to provide training and education about its appropriate use.
“AIS is a serious challenge to surgeons, patients, and their families,” said Suken Shah, M.D., spine surgeon at the Alfred I. DuPont Hospital for Children in Wilmington, Del. “New treatment options based on proven technologies provide surgeons with more choices to help more patients.”
Scoliosis can lead to chronic back pain and reduced respiratory function, and impact quality of life by limiting activity and affecting self-esteem. If the curvature of the spine is between 25 to 45 degrees, back bracing is generally recommended in an attempt to stop curve progression. If the curve progresses beyond 45 degrees, spinal fusion surgery is considered to strengthen and straighten the spine. Most patients do not progress to a degree needing surgical intervention. According to the National Scoliosis Foundation, scoliosis patients make more than 600,000 visits to private physician offices, 38,000 children undergo spinal fusion surgeries and about 30,000 children are braced each year in the United States.
When JNJ purchased Synthes and merged it with its own spine division, DePuy Orthopedics, DePuy Synthes became one of the largest spine companies in the world dedicated to developing treatments and solutions for the full spectrum of spinal disorders including adult and adolescent deformity, spinal stenosis, trauma and degenerative disc disease.