Mazor’s X Align Software Cleared by FDA

Caesarea, Israel-based Mazor Robotics Ltd, has received FDA clearance for its Mazor X Align software. The software is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures performed with the Mazor X Surgical Assurance Platform

In an April 12, 2017 announcement, the company said this is the latest module to be added to the Mazor X proprietary Pre-operative Analytics software suite, and enables surgeons to create a patient-specific, three-dimensional spinal alignment plan. The 3D plan, according to the company, simulates an entire spine, allowing pre-operative estimation of the impact of a planned surgical correction on the patient’s posture post-operatively, considering segmental range-of-motion and final alignment parameters.

Mazor CEO Ori Hadomi said the company’s core technology has been used in over 23,000 procedures. “This unparalleled clinical and operating room experience has provided us with deep insight into what the surgeons want next for themselves and their patients. So, we pushed the envelope, moving from a precise mechanical system, to a complete expandable platform that incorporates integrated analytics and state-of-the art guidance.”

The Mazor X was first unveiled in July 2016. Hadomi said the pre-launch interest was “exceptional.” The system was officially launched at the 2016 North American Spine Society (NASS) annual meeting held in Boston, Massachusetts, and was displayed at the Mazor and Medtronic booths.

Hadomi said the commercial release of the system was a significant milestone for Mazor as well as for the company’s strategic partnership with Medtronic that was announced in May 2016. Since signing the agreement in May, Mazor and Medtronic have invested in co-marketing, promotion, and training efforts towards commercialization of the Mazor X. The two companies, according to a Mazor statement, now have “hundreds of highly experienced capital and clinical specialists who are trained on Mazor X, who will be responsible for raising the awareness of, selling and supporting the Mazor X system. In response to the pre-launch activity by Mazor and Medtronic, dozens of surgeons have attended Mazor’s labs and been introduced to the Mazor X.”

The company says it responded to surgeon interest in the system by establishing an exchange (post-sale) program for existing U.S. Renaissance users to expand to the Mazor X system. Since the July unveiling, the company says it has received three pre-launch orders prior to commercial launch, with scheduled deliveries by the end of the 2017 first quarter. Additionally, the company also received a purchase order from Medtronic for 15 Mazor X systems.