Periodic Reporting for period 1 - SURGIS (Open Platform for X-Ray robotics medical imaging and surgical navigation)
Période du rapport: 2016-08-01 au 2017-01-31
Over the last two decades, the number of surgeries using a minimally invasive (MIS) approach has increased exponentially. Thanks to smaller incisions and reduced collateral damage to soft tissue when compared to traditional surgery, MIS techniques are more likely to reduce intraoperative blood loss, decrease pain, and shorten postsurgical convalescence. This have been shown to translate into improved clinical outcomes and quality of life for patients, associated with potential significant reduction in healthcare expenditures.
Technological advances are fundamental to accelerate the adoption of MIS and computer-assisted surgical (CAS) systems (navigation systems, robotic assisted tools, visualisation devices) provide a broad range of tools that can assist surgeons before and during surgical interventions. CAS systems can be used as both training and research tools and in routine clinical practice. In trauma and orthopaedic surgery, CAS systems are used for fracture reduction, planning and positioning of implants as well as the accurate implantation of (fore e.g. hip or knee) prostheses. The technology combines virtualisation of the patient anatomy with real time integration and tracking of surgical instruments into the digitized image background, thus allowing the surgeon to navigate the surgical instruments and the bone in an improved, virtual visual environment. CAS improves overall accuracy, minimizing unnecessary surgical dissection combined with increased patient and surgeon safety.
In spinal surgery, intraoperative imaging and surgical approaches have evolved in tandem to reach MIS objectives. Multiple systematic reviews have demonstrated the superiority of CAS technique compared to others for pedicle screw placement but the increased need for image guidance also leads to increased radiation exposure because the use of fluoroscopy remains necessary to assist in confirming vertebral levels, checking spinal alignment, and guiding implant placement. For both patients and operating room staff, the delayed radiation exposure effect from this type of exposure is not trivial and creates a potential new public health problem; a recent study showed that orthopaedic surgeons have a fivefold increase in their lifetime of cancer rates compared with non-orthopaedic surgeons in a hospital setting.
To increase the rate of adoption of CAS for the overall benefit of patients, systems must become simpler to use, harmoniously integrate into the surgical workflow and become more cost efficient. To answer this need, the SURGIS project will bring to the market a disruptive, versatile and cost-effective 2D/3D robotic imaging system which natively integrates a powerful navigation station for precise intraoperative guidance during surgery. The SURGIS platform is the first CAS device that offers full integration of proprietary software/hardware components with a range of innovative surgical instruments to deliver a product with unsurpassed user-experience, accuracy/reliability and versatility. While competing solutions are based on “closed” systems with regards to applications, the unique SURGIS-OPEN framework will allow the integration of 3rd party applications to replicate the “one stop shop” model introduced with smartphones, further increasing the overall SURGIS value proposition.
Technological advances are fundamental to accelerate the adoption of MIS and computer-assisted surgical (CAS) systems (navigation systems, robotic assisted tools, visualisation devices) provide a broad range of tools that can assist surgeons before and during surgical interventions. CAS systems can be used as both training and research tools and in routine clinical practice. In trauma and orthopaedic surgery, CAS systems are used for fracture reduction, planning and positioning of implants as well as the accurate implantation of (fore e.g. hip or knee) prostheses. The technology combines virtualisation of the patient anatomy with real time integration and tracking of surgical instruments into the digitized image background, thus allowing the surgeon to navigate the surgical instruments and the bone in an improved, virtual visual environment. CAS improves overall accuracy, minimizing unnecessary surgical dissection combined with increased patient and surgeon safety.
In spinal surgery, intraoperative imaging and surgical approaches have evolved in tandem to reach MIS objectives. Multiple systematic reviews have demonstrated the superiority of CAS technique compared to others for pedicle screw placement but the increased need for image guidance also leads to increased radiation exposure because the use of fluoroscopy remains necessary to assist in confirming vertebral levels, checking spinal alignment, and guiding implant placement. For both patients and operating room staff, the delayed radiation exposure effect from this type of exposure is not trivial and creates a potential new public health problem; a recent study showed that orthopaedic surgeons have a fivefold increase in their lifetime of cancer rates compared with non-orthopaedic surgeons in a hospital setting.
To increase the rate of adoption of CAS for the overall benefit of patients, systems must become simpler to use, harmoniously integrate into the surgical workflow and become more cost efficient. To answer this need, the SURGIS project will bring to the market a disruptive, versatile and cost-effective 2D/3D robotic imaging system which natively integrates a powerful navigation station for precise intraoperative guidance during surgery. The SURGIS platform is the first CAS device that offers full integration of proprietary software/hardware components with a range of innovative surgical instruments to deliver a product with unsurpassed user-experience, accuracy/reliability and versatility. While competing solutions are based on “closed” systems with regards to applications, the unique SURGIS-OPEN framework will allow the integration of 3rd party applications to replicate the “one stop shop” model introduced with smartphones, further increasing the overall SURGIS value proposition.
Prior to the project start, the SURGIS platform was positioned at a pre-commercialisation phase; a first technology demonstration platform was available and had been tested in a simulated OR. All fundamental components, i.e. 2D, 3D X-ray imaging, surgical navigation had been tested singularly to reach a TRL of 6. During the project, a second prototype integrating all latest design changes and technical components was developed and installed in one OR of our clinical partner CHU Grenoble Alpes (CHUGA). A 4 months testing phase was carried out in collaboration with clinical experts from CHUGA and other leading centres to i) validate, under real OR conditions, all major aspects of the technology (self-calibration, image to navigation processing chain, real time navigation, ready to navigate instruments etc) and ii) collect detailed feedback on the overall SURGIS workflow, technology accuracy and robustness, user-friendliness etc from key opinion leaders and prospective end-users. More than 25 individual experimentations in the anatomy lab were carried out and, overall, the feedback from clinicians was overwhelmingly positive.
The disruptive concept of the platform (integration of 2D/3D imaging and navigation, self-calibration & automated and immediate registration), its performances (superior accuracy, shortest time to navigation, strong reliability) and its unique workflow (ready to navigate instruments) were constantly noted as potential game changing attributes. During the SURGIS project, a major technical breakthrough was also achieved: novel motion correction algorithms were developed with increased (sub-1 mm) reconstruction accuracy and the overall processing speed was brought down to 45s from image acquisition to navigation. The study also allowed production and iterative testing/validation of several prototypes of a range of ready to navigate surgical instruments for a first application. The whole SURGIS industrialisation process was defined and modelled by CATPRO and SGV. This entailed the identification of all subcontractors and integrators required to produce all sub-components of the device (imaging and operating units) and surgical instruments. Accordingly, the SURGIS project has now reached TRL 7. On the technical side, all innovative components have been integrated and the overall design of the final product is now validated and “locked”. The roadmaps (technical/financial) for initial commercial-scale devices have been established and the regulatory approval phase in Europe has been initiated with the submission of applications to obtain CE marking and ISO13485 certification.
The SURGIS feasibility study allowed to significantly consolidate the SURGIS value proposition via:
i) The experimental validation of several core innovations of the device (automated calibration, motion correction),
ii) A transparent evaluation of the overall performances (accuracy, reliability, time to navigation, ergonomics) of the platform by a panel of KOLs,
iii) An in-depth analysis of the targeted applications, markets, competitors profile/competitive landscape as well as the industrial environment (supply chain, sales and distribution networks),
iv) The definition of the full SURGIS industrialisation process (identification of all subcontractors and integrators, modelling of production process),
v) The identification of all applicable norms and regulations for the class IIa medical device as well as the implementation of a quality management system to support ongoing regulatory submissions,
vi) The definition of multiple financial scenarios to support the search for additional funding from both dilutive and non-dilutive streams,
vii) An in-depth evaluation of the SURGIS OPEN concept for the release of 3rd party applications.
The disruptive concept of the platform (integration of 2D/3D imaging and navigation, self-calibration & automated and immediate registration), its performances (superior accuracy, shortest time to navigation, strong reliability) and its unique workflow (ready to navigate instruments) were constantly noted as potential game changing attributes. During the SURGIS project, a major technical breakthrough was also achieved: novel motion correction algorithms were developed with increased (sub-1 mm) reconstruction accuracy and the overall processing speed was brought down to 45s from image acquisition to navigation. The study also allowed production and iterative testing/validation of several prototypes of a range of ready to navigate surgical instruments for a first application. The whole SURGIS industrialisation process was defined and modelled by CATPRO and SGV. This entailed the identification of all subcontractors and integrators required to produce all sub-components of the device (imaging and operating units) and surgical instruments. Accordingly, the SURGIS project has now reached TRL 7. On the technical side, all innovative components have been integrated and the overall design of the final product is now validated and “locked”. The roadmaps (technical/financial) for initial commercial-scale devices have been established and the regulatory approval phase in Europe has been initiated with the submission of applications to obtain CE marking and ISO13485 certification.
The SURGIS feasibility study allowed to significantly consolidate the SURGIS value proposition via:
i) The experimental validation of several core innovations of the device (automated calibration, motion correction),
ii) A transparent evaluation of the overall performances (accuracy, reliability, time to navigation, ergonomics) of the platform by a panel of KOLs,
iii) An in-depth analysis of the targeted applications, markets, competitors profile/competitive landscape as well as the industrial environment (supply chain, sales and distribution networks),
iv) The definition of the full SURGIS industrialisation process (identification of all subcontractors and integrators, modelling of production process),
v) The identification of all applicable norms and regulations for the class IIa medical device as well as the implementation of a quality management system to support ongoing regulatory submissions,
vi) The definition of multiple financial scenarios to support the search for additional funding from both dilutive and non-dilutive streams,
vii) An in-depth evaluation of the SURGIS OPEN concept for the release of 3rd party applications.
CAS systems almost invariably involve three major technological components for the discrete steps of data acquisition, registration, and tracking: precise and accurate navigation is directly linked to conceptual design choices from each of the three components detailed above. To date, no single commercial provides a truly integrated imaging and navigation solution simple to use yet extremely precise and adapted to multiple applications and medical scenario. Existing systems require cumulative capital investments: navigation devices cost around $140,000 to $220,000, and trauma software and additional tools may cost up to $60,000 while state of the art imaging devices with 2D/3D and navigation capacity can cost up to $1M. For CAS systems to gain more popularity and advance its application in trauma and orthopaedic surgery, it is key that medical device manufacturers address critical technological, operational and economic considerations, embedding the feedback of clinical experts into the technology development pathway. This is the core philosophy of the SURGIS project which allowed to overcome key conceptual hurdles of CAS devices.
Wider socio-economic impact
By the year 2030, over 1⁄2 of the adults in the EU population will be over aged 65 years. The economic effect of spine, hip and knee disorders of this aging population will have profound implications on the future affordability and availability of quality care. Based on surveys carried out in Canada, the United States, and Western Europe, physical disabilities caused by musculoskeletal conditions assume a 4%-5% prevalence in the adult population. Symptomatic degenerative spinal disorders are treated with a myriad of treatment strategies ranging from medical management, physical therapy, chiropractic adjustments, injections, to complex spine surgery. In 2005, $85.9 billion was spent on the treatment of low back pain, representing a 65% increase from 1997. However, a shift in health economics is occurring, away from traditional fee-for-service medicine, toward a value-based health care system where resource allocation will favor interventions that demonstrate both clinical efficacy and “value for money”.
Despite increased equipment and instrumentation costs, current data suggest that acute care costs for MIS spine surgery are significantly lower than for open surgical interventions, and thus may offset potential higher upfront costs of many MIS implants and equipment. Although data are still sparse, the cumulative effects of lower complication and infection rates, shorter length of stay (LOS), less blood loss, and potentially lower post-discharge resource utilisation, combined with a potentially quicker return to work, will clearly alter the direct and indirect costs of spine care. The use of surgical navigation is directly correlated to a reduction in implant malposition, from a rate of 15.3% in conventional surgery to 3.2% using surgical navigation. The total cost associated with the revision of a lumbar fusion is estimated at $ 32,915 ± $ 8344. The SURGIS project will accelerate the uptake of MIS techniques by providing surgeon with a set of dedicated, user-friendly tools that help them consistently achieve the targeted clinical outcomes and hence one major impact of the project will be to promote significant savings for both public and private health systems.
MIS has changed the paradigm of radiation risk for the surgical team. Radiation exposure to the surgical team is related to the indirect visualization of anatomic structures. Exposure is particularly high in spinal surgery as fluoroscopic guidance is used routinely during interventions and several studies have highlighted the importance of managing this risk for patients and operating room staff. To reduce this exposure, it is crucial to develop technologies such as 3D navigation that minimize the need for multiple x-ray images during surgery. One of the core differentiating technology of the SURGIS device is the inclusion of a proprietary X-ray dose optimisation algorithm that automatically calculates image acquisition parameters while limiting X-ray exposure and ensuring highest image quality to ensure the safety of patients and OR staff alike.
The last major societal impact of SURGIS is to consider access to care of obese patients, a population which often do not benefit from the latest technological advances in surgical devices. Obesity is one of the most prevalent health problems facing the United States today. While some commercial systems (e.g. O-arm fluoroscopes) display inherent design limitations to treat this specific patient population, the SURGIS system was conceptualised from its inception with these considerations in mind affecting the general design in terms of size and power of device, the development of specific MIS surgical instruments and specifically adapted protocols and device trajectories.
Wider socio-economic impact
By the year 2030, over 1⁄2 of the adults in the EU population will be over aged 65 years. The economic effect of spine, hip and knee disorders of this aging population will have profound implications on the future affordability and availability of quality care. Based on surveys carried out in Canada, the United States, and Western Europe, physical disabilities caused by musculoskeletal conditions assume a 4%-5% prevalence in the adult population. Symptomatic degenerative spinal disorders are treated with a myriad of treatment strategies ranging from medical management, physical therapy, chiropractic adjustments, injections, to complex spine surgery. In 2005, $85.9 billion was spent on the treatment of low back pain, representing a 65% increase from 1997. However, a shift in health economics is occurring, away from traditional fee-for-service medicine, toward a value-based health care system where resource allocation will favor interventions that demonstrate both clinical efficacy and “value for money”.
Despite increased equipment and instrumentation costs, current data suggest that acute care costs for MIS spine surgery are significantly lower than for open surgical interventions, and thus may offset potential higher upfront costs of many MIS implants and equipment. Although data are still sparse, the cumulative effects of lower complication and infection rates, shorter length of stay (LOS), less blood loss, and potentially lower post-discharge resource utilisation, combined with a potentially quicker return to work, will clearly alter the direct and indirect costs of spine care. The use of surgical navigation is directly correlated to a reduction in implant malposition, from a rate of 15.3% in conventional surgery to 3.2% using surgical navigation. The total cost associated with the revision of a lumbar fusion is estimated at $ 32,915 ± $ 8344. The SURGIS project will accelerate the uptake of MIS techniques by providing surgeon with a set of dedicated, user-friendly tools that help them consistently achieve the targeted clinical outcomes and hence one major impact of the project will be to promote significant savings for both public and private health systems.
MIS has changed the paradigm of radiation risk for the surgical team. Radiation exposure to the surgical team is related to the indirect visualization of anatomic structures. Exposure is particularly high in spinal surgery as fluoroscopic guidance is used routinely during interventions and several studies have highlighted the importance of managing this risk for patients and operating room staff. To reduce this exposure, it is crucial to develop technologies such as 3D navigation that minimize the need for multiple x-ray images during surgery. One of the core differentiating technology of the SURGIS device is the inclusion of a proprietary X-ray dose optimisation algorithm that automatically calculates image acquisition parameters while limiting X-ray exposure and ensuring highest image quality to ensure the safety of patients and OR staff alike.
The last major societal impact of SURGIS is to consider access to care of obese patients, a population which often do not benefit from the latest technological advances in surgical devices. Obesity is one of the most prevalent health problems facing the United States today. While some commercial systems (e.g. O-arm fluoroscopes) display inherent design limitations to treat this specific patient population, the SURGIS system was conceptualised from its inception with these considerations in mind affecting the general design in terms of size and power of device, the development of specific MIS surgical instruments and specifically adapted protocols and device trajectories.