Mazor Robotics announced on 3 May 2011 that it has received CE mark approval to market SpineAssist, its robotic spinal surgical system, for use in brain surgeries, including treatment to minimise the symptoms of Parkinson’s disease.
“We are very proud to have obtained the CE mark for the SpineAssist system for performing brain operations,” said Ori Hadomi, CEO of Mazor Robotics. “There are numerous benefits of using a precise robotic guidance system for brain surgery and we believe that having now performed over 2,000 surgeries, and accurately placing thousands of implants, SpineAssist provides Mazor with a significant competitive advantage over other systems currently being used in the brain surgery market.”
SpineAssist accuracy contributes to significantly lower complication rates, such as neurological deficits, when compared to free-hand procedures. According to the company, in the thousands of implants placed by SpineAssist, none have resulted in permanent nerve damage in patients.
Mazor successfully completed a series of complex trials at Hadassah Medical Center in Jerusalem, six months ago, 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 to receive FDA clearance to use SpineAssist in brain surgeries in the USA. In November 2009, the company signed a distribution agreement with Alpha Omega to market and distribute the SpineAssist system for deep brain stimulation (DBS) to hospitals in North America.
SpineAssist’s ability to accurately place implants will allow physicians using it to precisely localise and place electronic implants in the brain during DBS procedures, which help minimise the symptoms of Parkinson’s Disease, dystonia, chronic pain and depression.
“We are confident that SpineAssist will now be able to assist doctors to accurately and safely perform complex brain operations, helping to reduce pain and suffering for people around the world,” added Hadomi.