October 21, 2018
Results Published From IDE Study of Aortica's AortaFit Automated Case Planning Software
October 22, 2018—Aortica Corporation announced the publication of study results demonstrating the successful use of the company's investigational AortaFit automated case planning software to simplify the planning of the treatment and the delivery of fenestrated endovascular aneurysm repair endografts for complex abdominal aortic aneurysm (AAA) disease.
The findings from the physician-sponsored study conducted under an FDA investigational device exemption were published by Benjamin Starnes, MD, et al in Journal of Vascular Surgery (JVS; 2018;68:1297–1307).
The study was led by Dr. Starnes, who is Chief of Vascular Surgery at the University of Washington, and was administered in conjunction with Harborview Medical Center in Seattle, Washington. Dr. Starnes presented the data in September 2017 at the Western Vascular Society meeting held September 23–26 in Blaine, Washington.
In the company's announcement, Dr. Starnes commented, “The JVS publication reports on the first 30 patients treated using Aortica’s AortaFit automated case planning software. The software digitizes a patient’s CT scan and creates graft plans that are specific to each patient’s unique 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. The results in these first 30 patients are highly favorable with low morbidity and mortality. Graft implantation was successful in 100% (30/30) of patients, with 97% (84/87) of branch arteries preserved at index. 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 endoleaks through 30 days. Two deaths were reported, but both were unrelated to AAA disease.”