US-based Aurora Spine has received the Health Canada Medical Device Licence for its ZIP Interspinous Fusion System.
The ZIP MIS interspinous fixation implant for spinal fusion includes a one-step locking mechanism, articulating spikes and several sizes to accommodate variations in patient anatomy, eliminating the use of a set screw.
The system is a major product in the company’s Screwless-Procedure, an advanced surgical approach to spine fusion.
Screwless-Procedure was 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.
The company said these benefits will continue to be the driving force of its competitive advantage and growth.
Aurora Spine president Trent Northcutt said: “Aurora is changing spine surgery and we are excited to receive the Health Canada Medical Device Licence 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 company secured US Food and Drug Administration (FDA) clearance on the ZIP MIS Interspinous Fusion System. Aurora Spine already holds CE Mark and Australian Therapeutic Goods Administration (TGA) listing for the product.
The company is focused on bringing new solutions to the spinal implant market through a series of screwless, minimally invasive, regenerative spinal implant technologies.