Findings Reported on Fenestrated EVAR Procedures Using Aortica's Case Planning Software
September 25, 2017—Aortica Corporation announced that Benjamin Starnes, MD, reported successful results for the first 30 patients undergoing fenestrated endovascular aneurysm repair (FEVAR) procedures that were planned and performed using Aortica’s AortaFit automated case planning software. Results were presented at the Western Vascular Society meeting held September 23–26 in Blaine, Washington.
The cases are part of Dr. Starnes’ physician-sponsored study that is administered in conjunction with Harborview Medical Center in Seattle, Washington. The study is being conducted under an investigational device exemption (IDE) from the US Food and Drug Administration.
As the company noted, FEVAR is a highly effective treatment for more complex abdominal aortic aneurysm (AAA) cases in which branch arteries are too close to the origin of the aneurysm and complicate or preclude safely deploying a standard endograft in a EVAR procedure. However, given the currently available technology available, both the planning of where to place the fenestrations and the delivery of the fenestrated endograft are highly complex and time-consuming, thus significantly limiting adoption.
Dr. Starnes’ IDE study is evaluating technologies and methods to simplify both the case planning and the delivery of FEVAR endografts.
In the company's press release, Dr. Starnes commented, “I have now used Aortica’s AortaFit automated case planning software successfully in 30 patients overall, using standard endografts from three of the major manufacturers—Bolton, Cook, and Medtronic. The software digitizes a patient’s CT scan and utilizes an algorithm to account for the effect of the implant on the geometry of the anatomy to create an exact replica of each patient’s aortic anatomy as it would look with the introduction of the implant. The entire process takes just a few minutes to create an accurate multivessel fenestrated graft plan. This compares to the hours it takes to plan cases using manual planning and today’s existing technology. Because the graft plan is so precise, the software also simplifies the process of aligning and placing the endograft in the patient.”
Summarizing his findings, Dr. Starnes continued, "The results in these first 30 patients are highly favorable with low morbidity and mortality. Graft implantation was successful in 100% of patients (30/30), with 97% of branch arteries preserved at index (84/87). The three branch arteries not cannulated were due to complications not related to the graft plan. There have been no type Ia or type III ndoleaks through 30 days. Two deaths were reported, but both were unrelated to AAA disease.”
Aortica noted that further development of the FEVAR approach using the AortaFit system will be collaboration with an endograft manufacturer, moving beyond "physician modification" of endografts that were used in this study to direct manufacture of a FEVAR graft in the commercial setting so that FEVAR may become the preferred method of treatment for the vast majority of juxtarenal AAA patients and potentially any AAA patients with disease in the infrarenal neck.