Aortica Corporation announced that FDA has approved a supplement to an ongoing Physician Sponsored IDE study sponsored by Dr. Benjamin Starnes – Chief of Vascular Surgery at the University of Washington (UW). The supplement names Aortica as the supplier of both a Fenestration Alignment Software and a patient-specific 3-D printed fenestration template.
Together the software and the template comprise the investigationalAortaFit™ System, which is designed to improve treatment options for patients with juxtarenal Abdominal Aortic Aneurysms (AAA). Dr. Starnes, one of the world’s foremost authorities in the treatment of AAA, hopes that both the software and the 3D printed template could significantly reduce the need for invasive open surgery in patients suffering from aneurysms that are too close to branch arteries that supply blood to vital organs
The Fenestration Alignment Software utilizes a multi-factorial assessment to determine the precise location and size of branch arteries and designs a template with holes (or fenestrations) corresponding to the unique location of a given patient’s branch arteries.
Next, a 3D printer generates a template of the diseased section of the patient’s aorta, which is then used by surgeons to create fenestrations in the endograft. The modified endograft will perfectly match the patient’s anatomy and significantly increase the available endograft seal zone. As a result, blood flow is preserved to vital organs, and the patient avoids open surgery.
