Mazor Robotics’ Renaissance Surgical System Approved by Korean FDA

Mazor Robotics, a designer and manufacturer of surgical robots with as many as 12,000 implants successfully completed in the USA and Europe, is making an entry into the Asia Pacific area through its Korean distributor BR Holdings, who has procured approval to market Mazor’s Renaissance system from the Korean Food & Drug Administration (KFDA).

As a top-level robotic surgery technologies and instruments distributor in Korea, BR Holdings had taken on the responsibility of obtaining regulatory clearances from the Korean authorities to launch the Renaissance surgical guidance system designed specifically to help surgeons conduct spine surgeries with precision and safety.

The CEO of Mazor, Ori Hadomi believes that its flagship product Renaissance will be successfully marketed in Korea as robotic technologies have been well received by the Korean market in the past, proof of which can be seen in the Korean healthcare system which supports 36 da Vinci surgical robots. In 2008, 120,000 spinal surgeries were performed denoting an annual increase of 18% growth since 2003, making Korea the second largest spine surgery market, he added.

Mazor Robotics along with BR Holdings is all set to immediately start marketing Renaissance and gain local clinical practice and clientele.

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