FDA Expands IDE for Starnes' Study of Fenestrated EVAR

September 9, 2015—Aortica Corporation, an early stage private company founded by Benjamin W. Starnes, MD, Chief of Vascular Surgery at Harborview Medical Center in Seattle, Washington, announced that Dr. Starnes has received US Food and Drug Administration (FDA) approval to expand his physician-sponsored investigational device exemption (IDE) study. The IDE is designed to assess a new technology that seeks to significantly reduce the need for invasive open surgery in patients with abdominal aortic aneurysms (AAAs) in close proximity to (or encompassing) branch arteries. The study is being administered in conjunction with Harborview Medical Center. 

The approval allows Dr. Starnes to introduce a new software-planning tool and to expand the number of AAA endograft platforms eligible for use from one to five. To date, Dr. Starnes has enrolled and successfully treated more than 70 patients in the study, which is approved to enroll 150 patients.

In the announcement, Dr. Starnes commented, “Our goal is to simplify the process for managing these branch arteries and achieve a reliably sealed, securely anchored endograft at low cost. 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—called ‘fenestrated’ EVAR (or FEVAR) will allow physicians to protect the branch arteries by anchoring the graft securely in healthy tissue while preserving blood flow to vital organs.”

According to Dr. Starnes, 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.

Dr. Starnes continued, “In our study, we are introducing an algorithm that I call Patient Match Technology, which will dramatically simplify the FEVAR procedure. The algorithm digitizes a patient’s computed tomography scan and uses a three-dimensional printer to create an exact replica of each patient’s aortic anatomy. From this template, we can customize an ‘off-the-shelf’ endograft to precisely match each patient’s anatomy.” 

This algorithm is currently being refined and automated by Dr. Starnes’ Aortica Corporation. Dr. Starnes hopes to incorporate the Aortica software into the study in late 2015 or early 2016.

Dr. Starnes added, “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. 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.”