Robotic System Now Approved in U.S. for Brain Operations

Mazor’s Renaissance Robotic System Now Approved in U.S. for Brain Operations

CAESAREA, Israel, Jul 16, 2012 (BUSINESS WIRE) — Mazor Robotics Ltd. (tase:MZOR), a developer of innovative surgical robots and complementary products, today announced its Renaissance(TM) 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.”

About Mazor

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(TM), 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 .

Mazor Robotics, from Israel, has announced that the first robot-guided brain surgical procedures using the Mazor Renaissance platform have been successfully performed. The system, which mainly functions as a guidance system for surgical instruments and implants, is already cleared in the U.S. and Europe for spinal surgery, but Mazor is looking into expanding its indications for brain surgery. The first three cases (no word on what exact procedures were undertaken) were performed at HSK Hospital in Wiesbaden, Germany.

Applications in the brain will be for biopsies, shunt placements and neurostimulation electrode placement such as for deep brain stimulation. In these procedures it will be a viable alternative to the use of stereotactic frames for navigation. According to the company, the robot’s precision, simplicity and safety profile have the potential to increase patient comfort, improve surgical accuracy and provide a less invasive approach, as well as potentially increase utilization of the installed base.

The brain application will be available as an add-on to Mazor’s Renaissance system. It is expected to be available in early 2013 after it has received the necessary blessings of the regulatory bodies. The video below shows the system in action during spinal surgery:

Mazor Robotics’ Renaissance™ is transforming spine surgery from freehand procedures to highly-accurate, state-of-the-art robotic procedures, with less radiation—even for minimally invasive surgery (MIS), scoliosis, and other complex spinal deformity cases.

Powered by Clinically Validated Technology — Highly Accurate and Safe

Based on surgeons’ experience with thousands of SpineAssist® surgeries worldwide

Over 15,000 implants placed

No cases of permanent nerve damage

1.5 mm accuracy

Mazor Robotics Renaissance surgical system

Wide Range of Clinical Applications

Hardware and software tools enable a variety of spine procedures

Open, MIS, and percutaneous posterior thoracolumbar approaches

Scoliosis and other complex spinal deformities

Pedicle screws – short and long fusions

Transfacet screws and translaminar-facet screws

Osteotomies

Biopsies

Source :http://medgadget.com/2012/06/mazor-renaissance-robotic-surgery-guidance-system-completes-first-brain-surgeries.html

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