Physician-sponsored IDE study gains FDA approval to add more AAA devices and introduce planning tool


Benjamin W Starnes, chief of Vascular Surgery at Harborview Medical Center and an expert in the treatment of abdominal aortic aneurysms (AAA) has received US Food and Drug Administration (FDA) approval to expand his physician-sponsored Investigational Device Exemption (IDE) study, administered in conjunction with Harborview.

The study is designed to assess a new technology that could significantly reduce the need for invasive open surgery in patients with aneurysms that are too close to (or encompass) branch arteries that supply blood to vital organs. The approval allows Starnes to introduce a new software-planning tool and to expand the number of AAA endografts from one up to five. There are currently six manufacturers of commercially available AAA endografts in the USA. To date, Starnes has enrolled and successfully treated over 70 patients with AAA disease in the study, which is approved to enrol 150 patients.

Over the past 15 years, endovascular aneurysm repair (EVAR) has gradually replaced open surgery as a minimally invasive treatment option for the majority of patients with this disease. “Unfortunately about 40% of these aneurysmal patients have aneurysms that are either too close to branch arteries that supply blood to vital organs or the aorta itself is highly angulated,” said Starnes. “When this happens, it is difficult to place an endograft in the aorta and achieve a secure seal of the graft to the artery wall. As a result, the patient can experience a leak along the outside of the graft which causes the aneurysm to continue to grow. For these patients, EVAR is not an option and we have to treat them with open surgery.”

“Our goal is to simplify the process for managing these branch arteries and achieve a reliably sealed, securely anchored endograft at low cost,” he continued. “By creating openings (or fenestrations) in a standard ‘off-the-shelf’ endograft to correspond with the locations of branch arteries that feed the kidneys and other abdominal organs, we can treat patients using EVAR rather than subjecting them to open surgery. This approach—fenestrated EVAR (FEVAR)—will allow physicians to protect the branch arteries by anchoring the graft securely in healthy tissue while preserving blood flow to vital organs.”

Physicians have long appreciated the benefits of FEVAR, but have shied away from broad use in its current form because it is difficult to implement. Expensive equipment is required to make measurements that must be extremely precise. In addition, the physician must possess a high degree of skill and patience to carry out both the up-front planning and the procedure.

“In our study, we are introducing an algorithm that I call Patient Match Technology, which will dramatically simplify the FEVAR procedure,” said Starnes. “The algorithm digitises a patient’s CT scan and uses a 3D printer to create an exact replica of each patient’s aortic anatomy. From this template, we can customise an ‘off-the-shelf’ endograft to precisely match each patient’s anatomy.” This algorithm is currently being refined and automated by an early stage privately held company founded by Starnes called Aortica. He hopes to incorporate the Aortica software into his study later this year or early 2016.

“With FDA’s approval of this supplement to the IDE, we can begin to demonstrate the broad applicability of the Patient Match Technology across the vast majority of endografts available on the market today,” stated Starnes. “Down the road, we hope the addition of the Aortica’s automated version—called the Reflection system—will yield both a technology and an approach that will eliminate the hours of planning, heavy expense, and the general headache currently experienced by physicians and institutions interested in treating these patients less invasively.”