Applied Spine Technologies (www.appliedspine.com) has announced the first two Stabilimax surgeries performed outside of the United States. The surgeries were performed in Johannesburg, South Africa, by Ajay Maharaj, at Sunninghill Hospital.
The Stabilimax Dynamic Spine System is currently part of an IDE multicentre, randomised, controlled clinical trial in the U.S. Commenting on the procedure, Maharaj said, “Our first Stabilimax implantations went exceedingly well. We are pleased to be the first facility outside of the United States to take part in utilising this exciting new technology. Stabilimax offers an intriguing alternative to spinal fusion; the opportunity to stabilise the spine without eliminating motion for patients with spinal stenosis or herniated nucleus pulposus, in particular, is an area of great interest to me.”
Craig Corrance, CEO of Applied Spine adds, “We are very pleased to be partnering with Maharaj, as well as his colleagues Louis Nel and Jack Eksteen, in broadening the company’s experience with our Stabilimax System. South Africa offers Applied Spine the opportunity to collect valuable clinical data; but we are also most excited with the chance to commercialise Stabilimax in South Africa, utilising our CE Mark, for the growing number of surgeons interested in providing their patients with pedicle screw based motion preservation.”
About the IDE Clinical Trial
Applied Spine Technologies is currently conducting a multicentre, randomised, controlled clinical trial in the United States to compare posterior dynamic stabilisation using the Stabilimax Dynamic Spine Stabilization System to traditional spinal fusion stabilisation to treat degenerative lumbar spinal stenosis. The company has enrolled more than 100 patients to date.
Note: Stabilimax is an investigational device in the United States. It is limited by United States Federal Law for investigational use only.
