NuVasive announces FDA clearance to use MRI with MAGEC system

NuVasive Inc. announced at the North American Spine Society Annual Meeting the FDA has cleared MRI for use under certain conditions on patients who are implanted with the company’s MAGEC system. The system is the only noninvasive solution for growth modulation in pediatric spinal deformity cleared by the FDA.

According to a company press release, the clearance for magnetic resonance involved the conditions of use of a 1.5T Static Magnetic Field MRI machine at a maximum spatial field gradient of 3,000 gauss/cm (30 T/m) with a maximum MR System reported, whole body averaged specific absorption rate of 0.5 W/kg at 1.5T. As noted in the release, a maximum temperature rise of the MAGEC System of no more than 3.7° C. after 15 minutes of continuous scanning is expected under the scan conditions defined. The complete MRI safety information is included in the product labeling, the release noted.

“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 [early onset scoliosis] EOS,” Jason Hannon, president and chief operating officer of NuVasive, said in the release. “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.”

Reference:

http://www.marketwired.com/press-release/nuvasive-secures-magnetic-resonance-mr-fda-conditional-clearance-for-magec-system-nasdaq-nuva-2170210.htm