Aurora Spine has announced US Food and Drug FDA clearance of a new lumbar spinal stenosis indication for use for its ZIP family of minimally invasive (MIS) implants.
Adding lumbar spinal stenosis to the existing FDA-cleared indications of degenerative disc disease, spondylolisthesis, trauma, and tumour, allows physicians to identify and treat a new patient population using the ZIP MIS implants.
Steven Falowski, director of functional neurosurgery at Argires Marotti Neurosurgical Associates of Lancaster (Lancaster, USA), said: “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.
“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.”
The ZIP series of devices feature various bone anchors, Aurora Spine’s patented one-step locking mechanism with no set screw and a large graft space designed for biologic materials. The ZIP product line is Aurora Spine’s minimally invasive interlaminar fixation implant for spinal fusion and was developed as an alternative to pedicle screw fixation.
Vipul Mangal, an interventional pain specialist from National Spine and Pain Centers (Fort Washington, USA), 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.”
Trent Northcutt, president and chief executive officer of Aurora Spine, added: “The receipt of the additional lumbar spinal stenosis indication for our ZIP MIS interspinous fusion system is another key milestone for Aurora Spine and allows us to expand our spinal product portfolio.
“This achievement is a testament to the ongoing dedication and perseverance of our team. I am delighted we have obtained the additional FDA indication, especially given the overwhelming response for the ZIP devices. The success of our screwless spine procedure is a testament to our laser focus on disruptive technology and our commitment to ‘simplifying the complex’.”
The Aurora Spine ZIP MIS interspinous fusion system is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease, lumbar spinal stenosis, spondylolisthesis, trauma, and/or tumour. The Aurora Spine ZIP MIS interspinous fusion system is intended for use with bone graft material and is not intended for standalone use.
Laszlo Garamszegi, chief technology officer of Aurora Spine, commentated: “The ZIP MIS interspinous fusion system is a key product in Aurora Spine’s Screwless-Procedure—a cutting-edge surgical approach to spine fusion. The Screwless-Procedure has been developed to increase the possibility of significant benefits to patients, hospitals, and surgeons, including reduced surgery time, shorter hospital stays, and significantly faster recovery time. These benefits will continue to be the driving force of Aurora Spine’s competitive advantage and growth.”