Miniature Spine Surgery Robot Approved by FDA

By Robin Young

The FDA last week approved Mazor Technologies innovative miniature spine surgery robot, SpineAssist, for use in all types of spine surgeries. The device is no bigger than a soda pop can. Sitting on top of the spine, it guides spine surgeons to exactly the right position for tools and implants more quickly and accurately than currently employed techniques.

By reducing the risk of misplacement of implants and improving accuracy for the surgeon, Mazor’s SpineAssist should be able to shorten surgery time, increase accuracy and minimize the risk of medical failures and complications. Additionally, SpineAssist makes minimally invasive surgical procedures safer and available to a wider range of surgeons. By facilitating MIS spine surgery, Mazor’s product should improve patient recovery times and minimize the associated risks of spine surgery.

The system was clinically tested on cadavers at the Cleveland Clinic Foundation (CCF) by a team lead by Prof. E. Benzel and Dr. I. Lieberman. It is in the midst of clinical human trials in several spine centers in Israel (Sheba Medical center, Rabin Medical Center and Carmel hospital). CCF, a leading center in spine surgery, and the Israeli centers will be the first to perform surgeries with the SpineAssist.

Every year, over 500,000 spine surgeries are performed in the US alone, with an average growth rate of 8% per annum. This creates a large potential market for the SpineAssist.

With FDA approval (and CE Mark, which was also obtained this month) Mazor is turning its attention to marketing the device in the U.S.

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