NuVasive Inc. (NSDQ:NUVA) said today it won expanded FDA clearance for its Magec system, now indicated for safe use with 1.5 tesla magnetic resonance imaging devices.
The San Diego, Calif.-based company’s Magec system is a magnetically controlled growth modulation system cleared by the FDA for pediatric spinal deformity, which the company claims is a 1-of-the-kind device on the market
“Having clear, defined guidance for conditional MRI compatibility with Magec helps alleviate uncertainty that may have limited surgeons from using the innovative Magec system. This clearance opens up the door for more patients and their families to benefit from this life changing technology,” Dr. Suken Shah of the Nemours/Alfred I. duPont Hospital for Children said in prepared remarks.
The company said that the clearance will allow early onset scoliosis patients access to MRIs, something their treatment often requires multiples of. NuVasive said that, in the past, a lack of guidance on MR conditions was a hurdle for surgeons in adopting the Magec treatment.
“As the only noninvasive growth modulation system on the market, this clearance is a key milestone in overcoming a known barrier in the treatment of children with EOS. NuVasive is consistently on the cutting-edge of the latest treatment options and we work diligently to bring that innovation to as many patients as possible around the world,” prez & CEO Jason Hannon said in a press release.
In August, NuVasive said the Centers for Medicare and Medicaid Services granted a new technology add-on payment for magnetically controlled growth rods, including the company’s Magec system.
Earlier in August, NuVasive significantly lifted its guidance for the year after reporting 2nd quarter earnings that topped Wall Street’s expectations and saw sales and revenue grow significantly from last year’s 2nd quarter.
