During the five-and-a-half-year Action, which was affected by the COVID-19 pandemic in 2020 and 2021, the consortium produced an advanced system for use in convection-enhanced drug delivery. EDEN2020’s steerable catheter, which is inspired by the egg-laying channel of certain insects, was produced at a size and with materials suitable for clinical use; featuring eight working channels for drug delivery, optical-based theranostic modalities, and shape sensing. It was complemented by an ecosystem of technologies to support the agile delivery of pharmaceuticals to procedure-optimised targets within the brain. EDEN2020 resulted in advancements to the state-of-the-art in three-dimensional intraoperative ultrasound imaging; catheter shape sensing based on fibre brag gratings technology; advanced preoperative imaging based on state-of-the-art MRI sequences; and a commercial front end, coupled with a state-of-the-art stereotactic robotic system, both of which have been upgraded for use within EDEN2020. In Period 1, the ethics behind the complex array of clinical trials on both human and ovine models starting in year 2 of the project was completed, and detailed experimental protocols, platform specifications and design considerations were defined for each phase of the study. In Period 2, the consortium made significant progress on all fronts: platform development, pre- and intra-operative imaging, image processing and sensorisation, and human and ovine clinical trials. In Period 2, the consortium delivered a family of pre-production steerable catheters within a bespoke blister pack, produced a complete robotic catheter driver, and a functional intelligent planner able to identify optimal curvilinear paths between a desired entry point and target pose. Tests in vivo with rigid catheters were also carried out as to provide the gold standard for ecosystem validation. In Period 3, the consortium completed all technical deliverables, implemented all system modules to specification, and integrated these in a fully functional prototype system which was deployed, verified, and validated both in vitro and ex vivo on the ovine model. In Period 4, the consortium came together to complete the in vivo clinical trials of the integrated EDEN2020, albeit with a significant reduction in ambition and scope compared to the original Annex. Owing to the ongoing global pandemic and extensive cost-neutral extension (18 months overall), which affected the consortium’s ability to retain key staff, travel, move key equipment and support the clinical team in Lodi during the trials, only two live robotic-assisted surgeries on sheep were performed over the summer of 2021. Additionally, a collection of benchmarking trials of the system, carried out by consortium partners in isolation, was performed to assess sub-system performance against the literature and competing systems for which performance metrics were available in the public domain.
Regardless of the significant deviations in P4, which were unavoidable, this Research and Innovation Action remains a success and a testament to the significant efforts behind this complex, integrated project, which holds the promise to enhance the quality of life of cancer patients in the not-too-distant future. The project supported by a comprehensive, user-led specification, was meticulously put together borrowing from industrial R&D templates and practices with a view to facilitating eventual commercial exploitation of EDEN2020’s outputs, which has already begun: completion of a detailed customer discovery phase, the start of commercial spinout conversations with the coordinating institution, and early licensing discussions with potentially interested corporate partners.
