Mazor Robotics Receives FDA Approval For Robotic-Guided Surgical Implants
Company Expects to Begin Marketing Implants in Second Half of 2011
Mazor Robotics Ltd., a developer of innovative surgical robots and complementary products, announced recently that it has received approval from the U.S. Food and Drug Administration (FDA) for the marketing of Emerald, Mazor Robotics' guided-surgical implant system for spinal fixation procedures.
Mazor's flagship product, SpineAssist, is a surgical robotic system that enables surgeons to conduct spine surgeries in a safe and accurate manner. The system consists of a robot that is mounted on the spine during surgery and a workstation that runs advanced surgical planning software. Emerald implants are used to fixate vertebrae in multiple spine procedures (over half a million such procedures occur in the US annually). Payment for such implants in the U.S. is around $6,000-8,000.
"We are encouraged to receive FDA clearance for another one of our products, and we are confident that this new implant system will strengthen our position in the spinal surgery market," said Ori Hadomi, CEO of Mazor Robotics. "Emerald implants are specially designed to work with our robotic system, creating synergy with the SpineAssist, which facilitates the surgical procedure, benefiting both patients and surgeons."
The Emerald implant successfully met all of the bio-mechanical and regulatory compliance requirements of the FDA. Additionally, the implant has been developed with the support of leading surgeons in both the U.S. and Europe.
Mazor expects to begin marketing Emerald in the second half of 2011.
Mazor Robotics is dedicated to the development and marketing of innovative surgical robots and complementing products that provide a safer surgical environment for patients, surgeons and OR staff. Mazor's flagship product, SpineAssist, is a specifically designed surgical robotic system that enables surgeons to conduct spine surgeries in an accurate and secure manner. The system has been successfully used in the placement of thousands of implants in the US and Europe. Multiple peer-reviewed publications and presentations at leading scientific conferences have validated the accuracy, usability and clinical advantages of SpineAssist. For more information, visit www.mazorrobotics.com
SOURCE: Mazor Robotics Ltd.