Aurora Spine’s ZIP Implants Earn FDA OK for Lumbar Spinal Stenosis

Aurora Spine has gained U.S. Food and Drug Administration (FDA) clearance of lumbar spinal stenosis indication for its ZIP family of MIS (minimally invasive surgical) implants. The ZIP MIS implants are already cleared for degenerative disc disease, spondylolisthesis, trauma, and tumors.
 
The ZIP implants have various bone anchors, a one-step locking mechanism with no set screw, and a large graft space for biologic materials. Developed as an alternative to pedicle screw fixation, the ZIP line is Aurora’s minimally invasive interlaminar fixation implant for spinal fusion.
 
“Aurora’s ZIP device bridges the gap between larger traditional fusion surgery and other interventional conservative measures delivering a minimally invasive option to offer a treatment option to more patients. The ZIP’s new Lumbar Spinal Stenosis indication will give access for more patients to receive this treatment option to improve their quality of life and alleviate their pain,” Steven Falowski, M.D., Director of Functional Neurosurgery at Argires Marotti Neurosurgical Associates, told the press. “Lumbar spinal stenosis is one of the most common causes of patients needing to undergo spinal surgery and is estimated to grow by 18 million patients in the next decade. This indication for the ZIP device will increase access to care for more patients and is an excellent alternative to more invasive open fusion procedures.”
 
Vipul Mangal, M.D., an interventional pain specialist from National Spine & Pain Centers, has adopted various therapies and favors any minimally invasive and alternative approach. Dr. Mangal commented, “The ZIP device has been revolutionary in my practice as a minimally invasive device to significantly improve function and pain for my patients with back pain. Aurora’s new Lumbar Spinal Stenosis clearance allows me as to use the ZIP implant for a wider range of indications and address the current stenosis issue in middle age and older patients. This is a major step forward in delivering the best options long term for your patients.”
 
The company’s DEXA SOLO-L ALIF implant earned FDA clearance last month.