Mazor Robotics’ Renaissance Technology Receives U.S. FDA Clearance for Brain Applications
7/16/2012 10:04:05 AM
CAESAREA, Israel--(BUSINESS WIRE)--Mazor Robotics Ltd. (TASE: MZOR), a developer of innovative surgical robots and complementary products, today announced its Renaissance™ platform received U.S. FDA marketing clearance, expanding the applications of the Renaissance system to include the precise positioning of surgical instruments and implants during brain surgery.
The Renaissance technology, a surgical guidance system originally designed for use in spine surgeries, is applicable in brain procedures for many applications including biopsies, shunt placements and neurostimulation electrode placement for deep brain stimulation (DBS). Along with the system’s precision, simplicity, and safety profile, the Renaissance System will also provide a frameless treatment solution for brain procedures. Renaissance has already been successfully employed in several clinical brain surgical procedures in Europe. 34 hospitals globally are currently using Renaissance for the different types of spine surgery.
“While our core is spine surgery, we are thrilled that our technology can be expanded to improve other surgical procedures,” stated Ori Hadomi, chief executive officer. “As neurosurgeons focus on both the spine and brain, brain surgeries represent a large market opportunity that is closely aligned with our current focus. Achieving U.S. regulatory clearance provides us with the opportunity to assist neurosurgeons in improving brain surgery processes and the ensuing clinical outcomes.”
Mazor Robotics (TASE:MZOR) is dedicated to the development and marketing of innovative surgical robots and complementary products that provide a safer surgical environment for patients, surgeons, and operating room staff. Mazor Robotics’ flagship product, Renaissance™, is a state-of-the-art surgical robotic system that enables surgeons to conduct spine surgeries in an accurate and secure manner. Mazor Robotics systems have been successfully used in the placement of over 20,000 implants in the United States and Europe. Numerous peer-reviewed publications and presentations at leading scientific conferences have validated the accuracy, usability, and clinical advantages of Mazor Robotics technology. For more information, please visit www.mazorrobotics.com.
Robert Jones/Aimee Gordon, 646-201-5447
Steve DiMattia, 646-201-5445