“These first-in-man cases are significant milestones for Aortica,” said Tom Douthitt, Aortica CEO. “FEVAR offers so many advantages for a dramatically underserved patient population. Unfortunately, the current endovascular treatment options for juxtarenal aneurysms—chimneys, commercially available FEVAR, and short neck grafts—all suffer from clinical limitations, complexity, and long procedure times. Consequently, none of these approaches enjoy widespread adoption,” continued Douthitt. “Our team has patterned the Fenestration Alignment Software after the manual method used by Dr. Starnes in an effort to automate and simplify FEVAR and provide a tool that many more physicians might use. To see the AortaFit™ System used successfully in these initial cases using standard endografts from two different manufacturers is tremendously satisfying. The study is approved to use grafts from multiple graft manufacturers in the US, and we look forward to continuing our clinical evaluation in Dr. Starnes’ study.”
About Abdominal Aortic Aneurysm (AAA) Disease
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Each year between 150,000 and 180,000 people in the United States are diagnosed with abdominal aortic aneurysms (AAA). An aneurysm is a large bulge in the aorta (the largest artery in the human body). It can gradually expand over time—without any symptoms—until it bursts, causing massive internal bleeding that results in death if not treated at a specialized center immediately. For years, major open surgery was the only treatment option, which is risky due to its complicated nature and because it carries a 3.0% mortality rate within 30 days of surgery.
About Endovascular Aneurysm Repair (EVAR)
In the 1990’s, a new technique for controlling aneurysms was developed using a graft inserted through the femoral arteries. This technique is called endovascular aneurysm repair (EVAR). EVAR is significantly less invasive than 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.
About Aortica Corporation
Aortica Corporation was founded to design, manufacture, and market tools for treatment of patients with AAA disease who have aortic anatomy that limits their treatment options. While EVAR has become a highly desirable option for treatment of AAA disease, approximately 40% of patients are not candidates for EVAR because their aortic anatomy is structured in a manner that does not allow an endograft to be anchored properly without blocking blood flow to vital organs. These patients face either open surgery or may be treated sub-optimally with standard EVAR. Aortica is dedicated to simplifying Fenestrated EVAR (FEVAR), and advancing the science of Personalized Vascular Therapy.
