Abstract
Paradoxically, a day after we report DePuy’s FDA problems with “custom” products in the USA, we’re also covering Stanmore Implants Worldwide’s announcement of its launch of a unique, fully personalised knee implant system. Ignoring the regulatory discussion about what constitutes a custom product in the EU compared with FDA’s view, is there demand for bespoke implants?
Background
Stanmore specialises in the design and manufacture of patient-specific and modular implants. Its “Savile Row” system tailors the whole pathway in early intervention knee surgery to the patient. The Company combines its robotic bone preparation with a patient-specific knee design, licensed from Imperial Innovations and based on IP from Imperial College London.
The first procedure using this approach was successfully performed in the UK in July and early results in the first group of 20 patients to receive the knee so far are very encouraging, with early patient mobility and excellent knee function.
The Savile Row custom offering
Stanmore uses CT scan data to design a personalised and optimised knee implant exactly matched to the patient. This type of knee design is called a unicondylar knee as only one part of the worn knee joint is replaced, leaving healthy, functional tissue in place. By using this approach, minimal bone is removed offering both faster recovery and improved function compared with more invasive traditional techniques, which remove both worn and healthy bone.
Surgeons can directly review and approve each implant using the Company’s online design service; a technology-led video conferencing and electronic communication tool. Once the design has been approved, Stanmore uses computer assisted manufacturing techniques to produce personalised implants in a cost effective manner with great accuracy.
The same knee design is loaded into Stanmore’s Sculptor intra-operative system, which uses a robot arm to ensure that the surgeon accurately prepares the bone surface to match the implant precisely. This high technology approach offers significantly enhanced precision in comparison with the conventional use of hand held saws and metal jigs, which is the current standard method for bone preparation in knee surgery.
Commercial availability
Stanmore plans to collaborate with a number of leading UK centres to manage a carefully controlled introduction of this new approach to knee replacement. The approach will also be extended to hips and other joints over time and Stanmore has plans to leverage the technologies harnessed within this system to further enhance its position as a world leader in tumour surgery solutions.
Company comments
Brian Steer, Executive Chairman of Stanmore, said; “With this system we have created a tailor made, “Savile Row” approach to knee surgery, which gives patients a completely personalised treatment, from the initial assessment to knee replacement surgery and aftercare. We believe that a patient-matched implant using the increased accuracy of our unique robotic technology is a major advance for orthopaedic surgery at little or no extra cost compared to off-the-shelf implants.
“Accurate placement of orthopaedic implants has been shown to be of critical importance to the longevity of the implant, thus avoiding early revision. Robotics and computer assisted navigation, widely used in other surgical specialities, is one of the fastest growing sectors in orthopaedics and Stanmore is ideally placed to continue producing innovative solutions for the worldwide orthopaedic market.”
Clinician comments
Professor Justin Cobb, Professor of Orthopaedic Surgery at Imperial College London and orthopaedic surgeon at Charing Cross Hospital, said; “The Stanmore Sculptor system gives the surgeons access to a new world of surgical precision, enabling them to perform the operation reliably and minimally invasively. Surgeons can now plan knee surgery based upon their patients’ own anatomy and are no longer limited by the sizes available on the hospital shelf. It also gives patients confidence that the latest technology is being used to ensure the procedure runs smoothly.”
Medlatest comments
Unicondylar knee implants are in daily use in a non-customised setting. If Stanmore can truly deliver a customised offering in a cost-effective way they will be on to something, but the price pressures in play at the present time are likely to result in some searching commercial discussions.
Source: Stanmore Implants
published: January 20, 2012 in: Companies, Knee, Launches / Withdrawals, News