FDA approves Aortica to supply AortaFit system for physician-sponsored investigative device exemption study


The US Food and Drug Administration has approved a supplement to an ongoing Physician-Sponsored IDE (investigative device exemption) study sponsored by Benjamin Starnes, chief of Vascular Surgery at the University of Washington, USA.

The supplement names Aortica as the supplier of both a fenestration alignment software and a patient-specific 3D-printed fenestration template. Together, the software and the template comprise the investigational AortaFit system, which is designed to improve treatment options for patients with juxtarenal abdominal aortic aneurysms (AAA).

Starnes 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. To date, Starnes has enrolled and successfully treated over 80 AAA patients in the study, which is approved to enrol 150 patients.

Tom Douthitt, Aortica chief executive officer, says, “Starnes and only a very few others around the world have been treating these patients with challenging anatomy using ‘manual’ techniques that require expensive equipment, a high degree of skill, and hours of planning. The combination of challenging anatomy along with the complexity of managing these patients’ endovascularly results in the patient typically being sent to surgery, which results in higher mortality rates, longer hospital stays, and greater costs.” He adds, “We hope that Starnes’ study demonstrates that the AortaFit system will greatly simplify the process for managing these patients using less invasive and highly desirable Endovascular Aneurysm Repair (EVAR) rather than open surgery.”

“Accurately planning these cases using current manual techniques is challenging, time consuming, and fraught with error for less experienced surgeons,” states Starnes. “Consequently, surgeons tend to shy away from fenestrated EVAR because they can’t accurately predict how the endograft will alter the existing anatomy. The team at Aortica has replicated and automated the manual technique I have used successfully in nearly 200 fenestrated cases. The AortaFit system removes the time, the expense, and the headache of planning fenestrated EVAR, and really simplifies what has historically been a very complex process.”

The fenestration alignment software utilises a multi-factorial assessment to determine the precise location and size of branch arteries and designs a template with 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 is designed to perfectly match the patient’s anatomy, and to significantly increase the available endograft seal zone. As a result, blood flow should be preserved to vital organs, and the patient should avoid open surgery.

“With FDA’s approval of this IDE supplement, we hope the study will yield two broad outcomes: first to provide vascular surgeons the tools to facilitate the provision of personalised vascular therapy, consistent with the national Precision Medicine Initiative; and second is the simplification of fenestrated EVAR,” explains Starnes.