Stanmore Implants out of Hertfordshire, England won FDA clearance for the Sculptor Robotic Guidance Arm (Sculptor RGA) to be used in partial knee resurfacing operations. The device, using technology called Active Constraint, essentially sets up an area around the knee beyond which the cutting tool is not allowed to travel, preventing the surgeon from straying outside a predefined safe region when removing tissue around the joint. From the announcement:
Stanmore’s unique personalised procedural approach to surgery seamlessly integrates advanced technologies. From proprietary planning software, personalised implants are designed in-house, then manufactured and placed precisely. During surgery, bone is removed corresponding to the implant shape whilst a tracking arm determines and monitors the location of the patient ensuring that the surgeon accurately prepares the bone surface to match the implant precisely.
This new and unique approach to the treatment of osteoarthritis of the knee has been used at a number of leading centres in the UK since the first patient specific personalised knee was implanted in July 2011 and builds upon the earlier clinical work undertaken using the Active Constraint™ technology featured in the Sculptor RGA™ device. Active Constraint™ technology has been shown to provide better functional outcome at 7 year follow up for partial knee surgery compared to the saws and jigs currently used in most knee surgery procedures, which are prone to a much higher degree of placement error.
Product page: Sculptor RGA (Robotic Guidance Arm)…
Press release: FDA Clears Sculptor Robotic Guidance Arm™ for Unicompartmental Knee Replacement Surgery
