Aortica Corp. today announced the publication of study results in the Journal of Vascular Surgery (JVS) demonstrating the successful use of their investigational AortaFit™ automated case planning software to dramatically simplify the treatment of complex Abdominal Aortic Aneurysm (AAA) disease. The study is an FDA approved physician-sponsored investigational device exemption (IDE) study, administered in conjunction with Harborview Medical Center and run by Dr. Benjamin Starnes, Chief of Vascular Surgery at the University of Washington (UW). Endovascular Aneurysm Repair (EVAR) is the gold standard for treatment of Abdominal Aortic Aneurysms (AAA). Unfortunately, over 40% of patients with AAA disease suffer from complexities that limit the successful use of EVAR. The complexity arises when branch arteries are too close to the origin of the aneurysm and complicate or preclude safely deploying a standard endograft. For these patients Fenestrated EVAR (or FEVAR) is an effective option in which holes (or fenestrations) are carefully created on the endograft to line up with branch arteries that supply blood to vital organs. Unfortunately, given the technology available today, both the planning of where to place the fenestrations and the delivery of the fenestrated endograft are highly complex and time-consuming, significantly limiting adoption. Dr. Starnes’ IDE study evaluated the use of AortaFit automated planning software as a means of simplifying both the case planning and the delivery of FEVAR endografts.
“The JVS publication reports on the first 30 patients treated using Aortica’s AortaFit™ automated case planning software,” stated Dr. Starnes. “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 multi-vessel 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,” 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 1a or type 3 endoleaks through 30 days. Two deaths were reported, but both were unrelated to AAA disease.”
“We are pleased to support Dr. Starnes’ study and publication of these successful results in JVS. We believe that AortaFit’s automated approach will dramatically simplify upfront case planning and device deployment thus opening up FEVAR for more physicians and patients,” stated Tom Douthitt, CEO of Aortica. “The next step will be to move beyond ‘physician modification’ of endografts used in this study, to a more elegant, simplified and rapid ‘direct manufacture’ of a FEVAR graft in the commercial setting. I believe FEVAR will then become the preferred method of treatment for the vast majority of juxtarenal AAA patients and perhaps any AAA patients with disease in the infrarenal neck.”
Note: In 2017, nearly 550,000 people worldwide were diagnosed with abdominal aortic aneurysms (AAA), and 200,000 of these required some form of repair. EVAR is a significantly less invasive option to open surgery and is associated with a mortality rate six times lower. Patients recover faster, leave the hospital sooner, and return to activities of normal daily life more quickly. Consequently, EVAR has become the gold standard for treatment of AAA disease. Unfortunately, 40% of patients requiring repair (85,000) have aortic anatomy structured in a manner that does not allow an endograft to be deployed safely without blocking blood flow to vital organs. FEVAR is the preferred treatment option for these patients. FEVAR involves placing reinforced, radiopaque holes (or fenestrations) in the endograft that align with branch arteries. This allows the physician to place the graft higher up in the aortic anatomy allowing for reliable anchoring and secure seal, while preserving blood flow to vital organs. Today only 6% of candidate patients receive FEVAR today due to the complexity of current FEVAR technology. Simplification of the procedure will result in significantly more patients becoming candidates for FEVAR therapy.