Frequently Asked Questions (FAQs) For Patients
Q: What is Renaissance™?
A: Renaissance is Mazor Robotics’ guidance system that allows surgeons to perform any spine surgery, from the simplest to the most complex--safely, accurately, and efficiently while reducing radiation and optimizing clinical outcomes. Independent scientific research has shown that using Mazor Robotics technology in minimally invasive surgery (MIS) increases surgical accuracy, lowers clinical complication rates, reduces pain, and enables faster recovery and return to daily activities. Research has also shown its superior accuracy, up to 99.7% (compared to around 90% in freehand surgeries), in complex surgeries such as scoliosis corrections.
Q: How safe is it?
A: Renaissance™ is powered by Mazor Robotics’ clinically proven technology-- used in thousands of surgeries worldwide, including placement of over 12,000 implants, without a single case of permanent nerve damage (which can occur in about 1-2% of cases operated freehand). Like all Mazor Robotics products, Renaissance™ strictly adheres to international quality and safety standards and has received several regulatory approvals, including FDA clearance in the USA and the European CE Mark.
Q: How precise is spine surgery with Mazor Robotics' Renaissance™?
A: Renaissance™ is designed to provide consistent accuracy to 1 mm (1/25 inch), which is superior to human ability. Mazor Robotics technology is highly precise and has been clinically validated in studies worldwide. For example, a recently published study demonstrated 98.3% accuracy for placing 3,271 implants in 635 cases in 14 international medical centers.
Q: What are the clinical benefits of Mazor Robotics technology?
A: Although statistics show that spine surgeries are generally quite successful, Renaissance™, Mazor Robotics’ guidance system, takes spine procedures to the next level with its consistent accuracy. Furthermore, Renaissance™ enables minimally invasive surgeries by replacing the surgeon’s need for a direct field-of-view with a surgical guidance system. Independent scientific research has shown that Mazor Robotics technology increases surgical accuracy, lowers complication rates, reduces pain, and aides in faster recovery with a quicker return to daily activities when compared to open, freehand surgeries.
Q: What are the advantages of minimally invasive surgery with Renaissance™?
A: In open surgery, the spine is exposed through a large incision to allow a full, direct field-of-view and access to the surgeon's hand and tools. In minimally invasive surgery, the surgeon makes small skin incisions to allow visualization of the operating field by retracting the tissues beneath the skin and exposing the spine. To compensate for this limited field-of-view, surgeons use fluoroscopy (X-ray) images to view their progress. Yet, even with imaging, comparative studies demonstrate that MIS accuracy is lower than in open surgeries (which offer a better, direct field-of-view). So, there is usually a clinical trade-off between accuracy and low exposure to radiation versus the advantages of MIS. Because surgeries with Mazor Robotics’ Renaissance™ are independent of the operating field-of-view, patients benefit from high levels of accuracy, low intraoperative exposure to radiation and the advantages of minimally invasive surgery.
Q: How will my surgeon work with Renaissance™? Is it independent?
A: Your surgeon will select the best treatment for your specific condition. Based on your CT-scan, your surgeon will use Renaissance™’s advanced 3D planning software to plan the optimal surgery customized for your anatomy and diagnosis. Once in the operating room, Renaissance™ guides your surgeon precisely to the preplanned anatomical location where intervention is necessary.
Renaissance™ is not independent and does not cut or perform any action on your body. Only your surgeon performs the required procedures such as placing implants. Your surgeon is in full control of the system at all times. Also, at any stage, your surgeon can decide to continue without the assistance of the Renaissance™.
Q: What should I expect before my surgery?
A: Before your surgery
• You will have CT images taken of your spine in preparation for your procedure.
• Your surgeon will use Renaissance™’s advanced 3D planning software with your CT images to create a unique surgical blueprint, which is the ideal surgery for your condition. This also provides increased safety and precision since it allows your surgeon to plan ahead, before entering the operating room.
The day of your surgery
• Once ready for your operation, you will be put under anesthesia.
• In the operating room, 2 fluoroscopy (low-dose X-ray) images will be taken of your spine, from the back and from the side.
• These images are merged together with your previous CT images by Renaissance™’s advanced 3D planning software, creating a unique 3D surgical blueprint to guide your surgeon according to the personalized preoperative surgical blueprint.
• Your surgeon will then dispatch Renaissance™ serially to each anatomical site planned on the preoperative surgical blueprint, working on each one to complete your operation with the greatest accuracy and safety.
Ask your surgeon for more information about how Mazor Robotics’ Renaissance™ will be used for your surgery.