Two cases have been successfully completed using the AorFit (Aortica) system to support simplified fenestrated endovascular aneurysm repair (FEVAR). The surgeries were performed by Benjamin Starnes, chief of Vascular Surgery, University of Washington, USA, as part of his physician-sponsored investigational device exemption study.
The AortaFit system comprises Aortica’s Fenestration Alignment software, and a patient-specific 3D-printed fenestration template.
In both surgeries, the presence of branch arteries near the aneurysms and angulated patient anatomy limited the available treatment options. Using only a CT scan, the Aortica software analysed each patient’s native aorta and determined how each endograft would influence the vessel geometry once implanted. Using this information, the software precisely determined the appropriate locations of fenestrations (or holes in the graft) to align with the branch arteries. A 3D printer then generated patient-specific AortaFit templates which were used in the operating room to guide the modification of each graft.
Standard “off-the-shelf” Medtronic and Bolton Medical endografts were used in these first two cases. By accounting for the branch arteries, the grafts provided a more secure fixation and seal while still allowing for blood to continue flowing to vital organs fed by the branch arteries.
Starnes says, “The Aortica software made case planning so much easier and the AortaFit template shortened the time for graft modification in the operating room. Our first case was a 74-year-old male with a 6cm juxtarenal aneurysm. The arteries that supplied his kidneys were only 7mm from the beginning of the aneurysm, meaning there was not adequate space to anchor a standard endograft,” continues Starnes. “Using the AortaFit System, we generated a three-fenestration template that precisely matched the anatomical requirements of our patient. I was able to very quickly and easily modify a standard Medtronic Endurant II endograft. The alignment of the fenestrations was perfect; the graft was easily placed and we increased the effective seal zone from 7mm to 39.2mm. The entire procedure took 1 hour and 53 minutes.”
“The second case was also a 74-year-old male who underwent open surgical repair 6 years earlier,” Starnes continues. “Unfortunately his disease continued to progress. The aneurysm had grown to 6cm, and was now located just 2mm from arteries branching out to the kidneys. Again the AortaFit system was used to quickly determine the location of three fenestrations, and to guide modification of a standard Bolton Medical endograft, enabling the patient to be treated endovascularly while increasing the effective seal zone from 2mm to 35.3mm.”
Tom Douthitt, Aortica chief executive officer says, “Our team has patterned the Fenestration Alignment software after the manual method used by Starnes in an effort to automate and simplify FEVAR and provide a tool that many more physicians might use.”