Mazor Robotics, Ltd. recently announced that it has received the CE Mark, allowing it to market SpineAssist, its robotic spinal surgical system, in Europe for brain surgeries and treatments to minimize the symptoms of Parkinson's disease.
To date, SpineAssist has been used in more than 2,000 surgeries worldwide, and has placed tens of thousands of implants in patients. The company feels their system’s accuracy contributes to significantly lower complication rates, such as neurological defects, when compared to free-hand procedures. To this point, none of the implants placed by SpineAssist have resulted in permanent nerve damage in patients.
Six months ago, Mazor successfully completed a series of complex trials at Hadassah Medical Center in Jerusalem, proving the system to be consistently accurate in performing brain surgery. The trials were carried out under the supervision of the hospital's neurosurgery department, and they exceeded the goals initially set by the research team. Having received the CE mark, over the next few months Mazor intends to begin using the system for surgeries performed on humans in both Israel, at Hadassah Medical Center, and in Germany.
Mazor has also applied with the US Food and Drug Administration to receive clearance to use SpineAssist in brain surgeries in the U.S. In November 2009, the company signed a distribution agreement with Alpha Omega, Ltd. for marketing and distribution of Mazor's SpineAssist system for Deep Brain Stimulation (DBS) to hospitals in North America.