IRVINE, Calif.--(BUSINESS WIRE)--Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today the initiation of the PTAB1 Post-Market Study. This study marks the beginning of a comprehensive post-market study aimed at evaluating the real-world performance of the 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 PTAB1 Post-Market Study evaluates the DETOUR System's performance in patients with very long (TASC D) SFA lesions. The study plans to enroll up to 450 subjects, with a focus on including at least 200 women and also features an imaging sub study. Recruitment will involve up to 200 sites, with five-year follow-up.
“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," expressed Matt Thompson, MD, President, and CEO of Endologix.
Dr. Thomas S. Maldonado, the Schwartz-Buckley Endowed Professor of Surgery in the Vascular Division at New York University Langone Medical Center, underscored the significance of being the inaugural site to enroll a PTAB patient. "Our privilege of enrolling the first patient in the PTAB1 Post-Market Study underscores our commitment to advancing patient care in complex PAD. 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."
About the DETOUR System
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.
About Endologix
Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes a variety of products in various stages of development that are designed to treat diseases that currently have clinically relevant unmet needs. Endologix's commercial products, including the AFX®2 Endovascular AAA System, ALTO® Abdominal Stent Graft System, and the DETOURTM 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 committed to advancing healthcare through investment, information, and philanthropy. The company has offices and manufacturing sites in Irvine, Milpitas and Santa Rosa, California. To learn more about Endologix, please visit https://www.endologix.com/.
About SVS VQI
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, 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. Over 1,000 participating centers are divided into 18 regional quality groups who meet biannually to discuss initiatives for improving the quality of vascular care. SVS VQI is powered by the Fivos cloud-based registry platform. To learn more about SVS VQI, please visit www.vqi.org [vqi.org].
