The Health Canada Medical Device License has been granted to Canada-based development-stage company Aurora Spine’s ZIP Interspinous Fusion System.
Designed to act as a key product in Aurora Spine’s Screwless Procedure, the ZIP MIS Interspinous fixation implant for spinal fusion features a ONE-STEP locking mechanism, articulating spikes and different sizes.
This helps to accommodate the variations in patient anatomy while eliminates the use of a set screw.
A surgical approach to spine fusion, the Screwless Procedure delivers significant benefits to patients, hospitals, and surgeons, including reduced surgery time, shorter hospital stays, and significantly faster recovery time.
Aurora Spine president and CEO Trent J. Northcutt said: "Aurora is changing spine surgery and we are excited to receive the Health Canada Medical Device License for our ZIP MIS Interspinous Fusion System.
"As a company traded on the TSX Venture Exchange, this is a significant milestone for Aurora Spine and its global growth.
"We are pleased to offer the ZIP MIS Interspinous Fusion System in Canada and introduce Aurora Spine’s advanced, innovative, minimally invasive spine surgery technologies which are designed to improve spine patient outcomes, drive continued surgeon interests and provide unique benefits that deliver value to hospitals and patients."
In November 2013, the US FDA clearance was given for Aurora Spine’s ZIP MIS interspinous fusion system, which already obtained its CE mark and Australian TGA listing for the product.
Image: Aurora Spine’s ZIP MIS Interspinous fixation implant for spinal fusion. Photo: courtesy of AURORA SPINE, INC.