Chinese patients facing tricky, dangerous back surgery can benefit now from the skills of Mazor Robotics, which develops technology to help surgeons more accurately and securely perform spine surgery. The China Food and Drug Administration (CFDA) has just approved the company’s Renaissance 3D imaging robotic surgery system, clearing the way for Renaissance to be installed in hundreds of hospitals in China.
China is just the latest country where Mazor has made an impact. It was approved by the FDA in the United States over three years ago, and dozens of the systems are installed in North America, Turkey, India, and Southeast Asia. The Caesarea-based company went public in the US about a year ago, and it’s traded on NASDAQ. According to Mazor, its spine surgery-assisting technology has been used in over 4,000 procedures worldwide. The company’s entry into the Chinese market will, Mazor said, significantly increase the number of customers deploying its technology.
Fractured or otherwise damaged vertebrae are one of the main causes of back pain, and when surgery is the only repair option, doctors usually fuse the damaged vertebrae with a neighboring healthy one, using pedicle screws and rods to prevent movement of the vertebrae during the fusion process. But spine surgery can be very dicey. If the surgeon misses, the screw might enter the spine itself, and that could cause serious damage to the nervous system.
Mazor’s award-winning back surgery technology aims to prevent such mistakes. Over the past decade the company has developed 3D modeling and automated robotic guidance, the tech that goes into Renaissance, its main offering. In order to insert the screws and rods properly, doctors need a clear picture of exactly where the insertion needs to take place. Mazor’s 3D imaging technology, replacing the 2D images available with less sophisticated systems, enables surgeons to get an accurate picture of what they need to do. With the image, they can program the Renaissance robotic insertion system to accurately place the stabilizers – preventing mistakes and problems that have forced as many as one in four patients to undergo repeat surgery.
Among the prizes Mazor has won for its technology was a recently bestowed “Stevie,” an International Business Award that is considered one of the most prestigious prizes in the commercial world. In a recent study led by a top surgeon in Istanbul, Renaissance was found to have a 98.5% accuracy rate in pedicle screw positioning, with no neurological, vascular or dural damage observed in subjects.
The system has proven so successful, in fact, that Mazor hopes to do for the brain what it has done for the back. In July, the company received its first order for its Renaissance Brain Surgery module. The system was sold to Bryan Medical Center in Lincoln, Nebraska, a 640-bed, not-for-profit, locally owned and governed health care organization serving patients from throughout the state, and it will be used for spine and brain procedures. The system was introduced just two months earlier at the annual meeting of the American Association of Neurological Surgeons (AANS).
Now Mazor is ready, willing, and able to serve the vast market for spine treatment in China, said Ori Hadomi, Mazor CEO. “Receiving CFDA’s approval for marketing the Renaissance system in China is a significant achievement for Mazor, giving us access to a large and growing market opportunity. China continues to adopt proven and state-of-the-art technologies to offer better patient outcomes, so we believe Renaissance is well-positioned to gain market acceptance,” he said.
“Our distribution partner in China, Cicel, believes the target market for Renaissance is in the hundreds of hospitals in China,” said Hadomi. “Now, with the CFDA approval, our partner will initiate its marketing and sales process to introduce Renaissance to this important market. Cicel has the local market knowledge and expertise along with the sales, marketing and clinical organization to quickly raise awareness of the Renaissance system.”