研究目的
To assess the safety and feasibility of Fiber Optic RealShape (FORS) technology, a new technology platform that enables real time three dimensional (3D) visualisation of endovascular guidewires and catheters, based on the concepts of fibre optic technology instead of fluoroscopy.
研究成果
The combined outcomes of high cannulation success, positive user experience, adequate accuracy, and absence of safety issues demonstrate the safety and feasibility of the FORS system in a preclinical environment. FORS technology has great potential to improve device visualisation in endovascular interventions.
研究不足
The number of FORS enabled guidewire and catheter configurations is currently limited. The FORS system supports the use anatomical roadmaps based on pre-operative CTA imaging, which can become less accurate due to differences in patient positioning, patient motion, and device induced vessel deformation.
1：Experimental Design and Method Selection:
Six physicians performed endovascular tasks in a phantom model and a porcine model using FORS enabled floppy guidewires, Cobra-2 catheters and Berenstein catheters.
2：Sample Selection and Data Sources:
The study used two preclinical models: a phantom model and a porcine model.
3：List of Experimental Equipment and Materials:
FORS enabled devices, Philips Allura Xper FD20 system or the Philips Azurion 7 FD20 system.
4：Experimental Procedures and Operational Workflow:
Each physician performed a set of predefined tasks in both models, including setup of the FORS system, device registration, and 12 aortic and peripheral target vessel cannulation tasks.
5：Data Analysis Methods:
The evaluation of the FORS system was based on target vessel cannulation success, safety assessment, the accuracy of the FORS based device visualisation, and user experience.
独家科研数据包，助您复现前沿成果，加速创新突破
获取完整内容
