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Mazor Robotics receives FDA approval for robotic-guided surgical implants
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Mazor Robotics Ltd., a developer of innovative surgical robots and complementary products, announced that it has received approval from the 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. Payment for such implants in the U.S. is around $6,000-8,000, according to a Mazor press release announcing the approval.
"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,” Ori Hadomi, CEO of Mazor Robotics, stated in the release. “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 United States and Europe, the company noted.
Mazor expects to begin marketing Emerald in the second half of 2011.