In 2012, UK-based Stanmore Implants is preparing to take on part of the world (the UK, Europe, and the United States) with a patient-specific knee system that integrates robotics. Although there are technologies that address patient-specific implant creation, the twist on the Savile Row system is that it integrates such an implant with robotics. “Everything from the planning phase through to the implant manufacture and surgical execution is personalized to the patient,” says Graeme Brookes, managing director of computer-assisted surgery and integrated technologies at Stanmore Implants. As a result, accuracy and reproducibility is introduced into the surgical procedure. The implant is a unicondylar knee replacement, which means it preserves more tissue than a total knee replacement.“The robot uses a technology called active constraint. The cutting element of the robot is free to move within a predefined space that is mapped out from the surgical plan. “It’s only when the cutting part of the robot is attempted to be moved into the wrong place that the robot switches on,” says Brookes. “It’s an active constraint mechanism to stop any bone preparation happening in the wrong area.” The technology comes from previously-acquired Acrobot, a spin-out from Imperial College (London). The knee implant was also developed at Imperial College, and the IP was licensed with Stanmore Implants.
The biggest competition to the Savile Row system is conventional surgery. However, using a robot eliminates multiple instrument trays, which would need to be sterilized and processed. A personalized implant also means less inventory management for hospitals. Although Brookes would not provide a cost position on the implant, he is confident that it will offer hospitals with a value proposition that is equivalent to what they currently have in terms of conventional instruments and off-the-shelf implants.
Stanmore Implants is slowly introducing the system to surgeons in a limited amount of centers in the UK. Surgeons have operated on the first group of 20 patients from which the company is gathering data. According to Brookes, the learning curve for surgeons hasn’t been deemed significant.
An obvious evolution would be to apply this technology to other joints (and nonjoint areas), and Stanmore Implants is headed in this direction. “This whole approach in implant development and in using the robot, there’s bandwidth to go vertically and horizontally with it, and that’s what we intend to do,” says Brookes, but he declined to give any clues.
For now, the company will be rolling out the product throughout the U.K. the year and has plans to expand into Europe as well. It will also file a 510(k) with FDA this year.