Endologix Initiates Postmarket Study of Detour System for Percutaneous Transmural Arterial Bypass

February 29, 2024—Endologix LLC announced the initiation of a postmarket study to evaluate the real-world performance of the company’s Detour system for percutaneous transmural arterial bypass (PTAB) in patients undergoing treatment of long, complex superficial femoral artery (SFA) disease.

According to Endologix, the PTAB1 postmarket study will enroll up to 450 patients, including at least 200 women, with very long (TASC D) SFA lesions. Recruitment will involve up to 200 sites. Follow-up will be 5-years. It will also feature an imaging substudy.

The PTAB1 study will leverage the Vascular Quality Initiative registry infrastructure developed and supported by the Society for Vascular Surgery Patient Safety Organization, noted the company.

In Endologix’ press release, Thomas S. Maldonado, MD, who is the Schwartz-Buckley Endowed Professor of Surgery in the Vascular Division at New York University Langone Medical Center in New York, New York, commented on being the inaugural site to enroll a patient in the study.

“Our privilege of enrolling the first patient in the PTAB1 postmarket study underscores our commitment to advancing patient care in complex PAD,” stated Dr. Maldonado. “The Detour system offers a glimpse into a future where minimally invasive treatments could redefine our approach to extensive SFA lesions. We are optimistic about the contributions this study will make towards evolving patient treatment paradigms.”