Aortica said today that a physician-sponsored investigational device exemption study of abdominal aortic aneurysm-treating endografts gained FDA approval to introduce a new software-planning tool and expand the number of endografts in the study.
The trial is designed to assess new technology that could reduce the need for invasive surgeries in patients with aneurysms that are “too close to (or encompass) branch arteries that supply blood to vital organs,” the Bellevue, Wash.-based company said.
“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 CT scan and uses a 3D 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 an early stage privately held company founded by Starnes called Aortica Corp,” lead investigator Dr. Benjamin Starnes of the Harborview Medical Center said in a press release.
Aortica, and Dr. Starnes, hope to incorporate Aoritca’s Reflection System technology into the trial later this year or in early 2016, according to a press release.
“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,” Starnes said in prepared remarks.
Aortica is developing a “patient-specific” solution that combines patient CT scans with proprietary software and 3-D printing to personalize endografts to fit each patients unique anatomy, according to the company.