First-in-Man Cases With Aortica's AortaFit System Support Simplified FEVAR

February 11, 2016—Aortica Corporation announced the successful completion of the first two cases using their AortaFit system to support simplified fenestrated endovascular aneurysm repair (FEVAR). The AortaFit system is an investigational surgical planning tool composed of Aortica’s fenestration alignment software and a patient-specific, three-dimensional printed fenestration template. 

The two procedures were performed by Benjamin Starnes, MD, who is Chief of Vascular Surgery at the University of Washington in Seattle, Washington, as part of his physician-sponsored investigational device exemption study. In both cases, the presence of branch arteries near the aneurysms and angulated patient anatomy limited the available treatment options, noted the company.

Using only a computed tomography scan, the Aortica software analyzed each patient’s native aorta and determined how each endograft would influence the vessel geometry when implanted. Using this information, the software precisely determined the appropriate locations of fenestrations to align with the branch arteries. 

Then, a three-dimensional printer generated patient-specific AortaFit templates that Dr. Starnes used in the operating room to guide his 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 to flow to vital organs fed by the branch arteries.

In the press release, Dr. Starnes commented, “These two cases represent a first step toward making FEVAR a simple procedure that is available to many more physicians and patients. The Aortica software made case planning so much easier and the AortaFit template shortened the time for graft modification in the operating room.” 

Dr. Starnes continued, “Our first case was a 74-year-old male with a 6-cm juxtarenal aneurysm. The arteries that supplied his kidneys were only 7 mm from the beginning of the aneurysm, meaning there was not adequate space to anchor a standard endograft. 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 7 to 39.2 mm. The entire procedure took 1 hour and 53 minutes.”

Dr. Starnes further explained, “The second case was also a 74-year-old male who underwent open surgical repair 6 years earlier. Unfortunately, his disease continued to progress. The aneurysm had grown to 6 cm, and was now located just 2 mm 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 2 to 35.3 mm.”