BIOMODEX, a digital health company that offers a unique and enhanced 3D printed solution for patient-specific rehearsal and physician training, last week announced the results of the first clinical study using the BIOMODEX EVIAS 3D printed models to plan aneurysm treatment using endovascular robotics and novel flow-diverter devices. The findings, which were published in the Journal of NeuroInterventional Surgery (JNIS) this month, demonstrate how use of the 3D printed aneurysm models for pre-procedural rehearsal allows physicians to rehearse for procedures more accurately and reliably.
The first-of-its kind study involved 8 patients with brain aneurysms who were scheduled for treatment using new devices or techniques. Two cases included simulation of stent-assisted coiling treatments using the assistance of a robotic arm by Corindus, a Siemens Healthineers Company, and six included rehearsal for first time use of new-generation flow-diverter stents, including the Silk Vista Baby by Balt and SurpassEvolve by Stryker. All rehearsals and procedures were performed by Dr. Vitor Mendes Pereira, a neurosurgeon and neuroradiologist at Toronto Western Hospital in Canada.
“This technology has the potential to increase operator confidence and improve patient outcomes, particularly in first in-human experiences using new devices and robotics. The rehearsals were instrumental in our recent successful completion of the world’s first in-human robotic-assisted neurovascular intervention,” said Dr. Pereira, senior author of the study and lead scientist of the RADIS lab research team.
Biomodex’s 3D training models were created based on each patient’s unique CTA scans and printed using a Stratasys J750 Digital Anatomy 3D Printer. Biomodex Invivotech material was used to simulate the biomechanics of the aneurysm and the surrounding tissue. The models are made with various flexible photopolymers which, unlike single material models like silicone, allow control of the pliability of the target area, providing critical tactile feedback. The models are connected to the EVIAS station which includes a hydraulic system to replicate blood flow. The research study, led by RADIS lab’s clinical research technologist, Nicole Cancelliere, found the models to be a reliable and accurate reproduction of the aneurysm features and the parent vessel anatomy.
“The rehearsals allowed the operator to address issues, such as device sizing, and practice challenging maneuvers, such as how to open flow diverter stents”, said Cancelliere, lead co-author of the study. The study demonstrated how various procedural challenges were successfully replicated during the patient’s treatment.
“These early results are encouraging and reconfirms initial anecdotal evidence,” said Biomodex CEO Ziad Rouag. “We are privileged to work hand-in-hand with key opinion leaders like Dr. Pereira and his team at Toronto Western Hospital to further develop our vision of establishing Biomodex as the standard-of-care in patient specific rehearsals. We look forward to announcing positive results on additional studies we have planned for our various other applications.”