First Simplified FEVAR Procedure Completed With Aortica's AortaFit and Bolton's TREO Systems

November 14, 2016–Aortica Corporation announced today that Benjamin Starnes, MD, Chief of Vascular Surgery at University of Washington, completed the first three-vessel fenestrated endovascular aneurysm repair (FEVAR) using Aortica’s AortaFit investigational automated case planning software and Bolton Medical’s TREO abdominal stent graft system.

FEVAR is a treatment for complex abdominal aortic aneurysm (AAA) cases in which fenestrations are carefully placed on the endograft to line up with branch arteries that supply blood to vital organs. These branch arteries often prevent physicians from reliably anchoring a standard graft. Dr. Starnes performed this FEVAR procedure as part of his physician-sponsored investigational device exemption study. The study is designed to evaluate technologies and methods to help dramatically simplify FEVAR.

According to Dr. Starnes, his patient, a 68-year-old man with a 6-cm aneurysm, had a very challenge aortic anatomy. “The arteries that supplied his kidneys were 10 mm from the origin of the aneurysm, meaning there was not adequate space to anchor a standard endograft,” explained Dr. Starnes in the company’s press release. “Patients with this level of complexity end up with very few treatment options other than maximally invasive open surgery.”

The AortaFit planning software, which has been a key part of the study since February, allowed Dr. Starnes the ability to generate a three-fenestration graft quickly and accurately. The TREO stent graft, an investigational AAA endograft developed by Bolton Medical, required US Food and Drug Administration approval to be used in the study. Within the United States, the TREO abdominal stent graft system is still an investigational device. It is available for commercial use outside the United States. Dr. Starnes said the device provided him with a mix of mechanical support and flexibility. "The flexibility of TREO enabled me to easily navigate the vessel angulation," he commented. 

“In all, we placed a graft that precisely matched the patient’s anatomy, and we increased the effective seal zone length from 10 to 54 mm,” he explained. “This is a key factor in achieving a result that is not only effective in the short term, but durable for the long term.”