Interview with a developer of eVidaVascular, software for the surgical planning of aortic aneurysms.
Question. Why a software for the surgical planning of aortic aneurysms?
A. An aortic aneurysm is a pathology associated with a widening of the aortic artery, which, depending on size, can rupture and risk the life of the patient. Rapid action is crucial. The intervention techniques of this type of pathologies have evolved a lot in recent years, and endovascular repair has been revealed as the gold standard.
This technique consists in implanting a stent within the aorta without opening the blood vessel or removing any tissue. But, for the surgery success, surgical planning including the selection of the right endoprosthesis is key. And that's where eVida Vascular becomes necessary.
The vascular surgeon needs to analyze the aorta of each patient based on a radiological study and then, check the features and measure to choose the most appropriate endoprosthesis for the patient. eVida Vascular helps in this planning process by offering tools for the segmentation of the aorta in 3D, measurement of the aorta with distances, diameters and angles, simulation of the initial position of the surgical arch and summary report of the planning.
Q. You ask for advice to vascular surgeons for the development. How did they help you?
A. Yes, from the first moment we received the advice from the Vascular Surgery service of the HU Donostia-San Sebastián, which has acted as both prescriber and clinical validator of the solution. Their advice has been crucial in the development, since they know the best the needs of a surgeon in the preoperative planning of vascular pathologies.
Q. How does eVidaVascular ease the work of these professionals? What difficulties does it help them solve?
A. The main advantages that our clients report are the ease of use and the confidence that the software offers for the surgical planning, as well as the guarantee and security with which they go into the operating room. All this means that the planning is faster, complications are avoided in the intervention, efficiency is gained and the post-operative of the patient is shortened.
eVida Vascular has interfaces that guide the professional in the planning-measuring process, which make easy to analyze both standard cases and fenestrated ones. It allows the planning of abdominal aortic, thoracic and iliac aortic aneurysms based on a 3D representation of the aorta while referring to 2D planes. There are tools for taking diameters, straight distances, distances through the center line of the vessel, angles, 2D/3D screenshots, initial position of the surgical arch, and so on. In addition, all the work done in the planning is saved for later reference and is included in a final report that can be exported to PDF.
Q. eVidaVascular is especially useful for the most urgent cases? Why?
A. Yes. EVida Vascular allows analyzing urgent cases and scheduled ones, although it is indeed in emergencies where eVidaVascular allows to have all the necessary information to quickly take the most appropriate clinical decision and react with guarantees.
Q. What requirements had to be met for its subsequent commercialization?
A. eVida Vascular is a computer program used for specific diagnostic purposes, and therefore, it is a Medical Device classified according to directive 2007/47 / EC. In order to be commercialized, both the product and the process to develop and create must be reviewed by a regulatory authority, including a clinical validation, to obtain CE certification. This certification ensures that eVidaVascular is safe for its intended use and is managed through a total quality system in accordance with Annex II (except point 4) of Directive 93/42 / EEC.
Q. Is it complicated to use?
A. Not at all. Our clients agree that it is very simple to use, and this is due to the fact that we have carried out an important task of planning and designing interfaces oriented towards final usability. The ease of use is a key aspect that we take into account in our developments.
Q. Do you offer technical assistance or training to facilitate learning?
A. Yes, in addition to the product itself we also offer support services and technical assistance, as well as specific professional training for our clients.
Q. Are complex equipment / computers required for its use?
A. No, eVida Vascular works on common computers in both Windows and Apple environments.
Q. What would you say to all those medical professionals who are reluctant to incorporate into their work the advantages offered by technological tools such as eVidaVascular?
A. I would say that technology can help to plan the cases in a very effective way and help to take better decisions. eVida Vascular is very simple to use and the user will be able to plan cases thanks to our interfaces in shorter times as the tool offers guidance along the process. Anyway, the surgeon can neglect the proposal based in his experience when required.
Q. Is the software getting better with new updates?
A. Yes. We have recently developed a new version that we hope to be able to commercialize shortly with several improvements and new features.
Q. In what other medical software solutions do you currently work?
A. During the first quarter of 2018 we are to launch a solution for the analysis of knee cartilage injuries based on magnetic resonance. It has been an important challenge that we hope will greatly facilitate the work of planning and diagnosing this type of injuries.