Endologix Examining Real-World Performance of its DETOUR System

Endologix LLC has begun the PTAB1 Post-Market Study, a trial aimed at evaluating real-world performance of the firm’s DETOUR System in patients undergoing treatment for long complex superficial femoral artery (SFA) disease. The study will leverage the Vascular Quality Initiative (VQI) registry infrastructure developed and supported by the Society for Vascular Surgery Patient Safety Organization (SVS PSO).  

“The initiation of the PTAB1 Post-Market Study represents a pivotal moment in our ongoing commitment to advance the treatment of complex peripheral arterial disease. Through this study, we aim to further validate the DETOUR System’s innovative approach to overcoming complex PAD challenges,” Endologix President/CEO Matt Thompson, M.D., President, said. 
 
The PTAB1 Post-Market Study will evaluate the DETOUR System’s performance in patients with very long (TASC D) SFA lesions. Trial investigators plan to enroll up to 450 subjects, including at least 200 women; the trial also will feature an imaging sub study. Recruitment will involve up to 200 sites with five-year follow-up.

PTAB with the DETOUR System offers a novel approach to treating complex PAD, enabling physicians to bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein via a transmural passage, to restore blood flow to the leg. This approach is effective for patients with long lesions (20cm-46cm in length), those that have already undergone failed endovascular procedures, or those that may be sub-optimal candidates for open surgical bypass. 

“Our privilege of enrolling the first patient in the PTAB1 Post-Market Study underscores our commitment to advancing patient care in complex PAD,” stated Dr. Thomas S. Maldonado, the Schwartz-Buckley Endowed Professor of Surgery in the Vascular Division at New York University Langone Medical Center. “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.”

Endologix LLC is a California-based medical device company developing therapies for interventional vascular disease treatment. Endologix’s therapeutic portfolio includes products in various stages of development that treat diseases with clinically relevant unmet needs. Endologix’s commercial products, including the AFX 2 Endovascular AAA System, ALTO Abdominal Stent Graft System, and the DETOUR System, are designed to treat a range of vascular diseases, from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix is wholly owned by Deerfield Management, an investment management firm. The company has offices and manufacturing sites in Irvine, Milpitas and Santa Rosa, Calif. T

The Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) clinical registry is governed by the SVS Patient Safety Organization (SVS PSO), a wholly owned subsidiary of the Society for Vascular Surgery, the latter of which provides oversight of data sharing arrangements, key outcome and quality measure analyses, and dissemination of information to participating providers. SVS VQI comprises vascular surgeons, cardiac surgeons, general surgeons, cardiologists, radiologists, and other specialists who perform vascular procedures collected in the VQI Registries, as well as Quality Improvement professionals, data managers and others dedicated to improving patient outcomes. More than 1,000 participating centers are divided into 18 regional quality groups that meet biannually to discuss initiatives for improving the quality of vascular care.