Endologix has announced the initiation of the Percutaneous transmural arterial bypass (PTAB)1 postmarket study. This study marks the beginning of a comprehensive postmarket 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), a company press release notes.
The PTAB1 postmarket study evaluates the Detour system’s performance in patients with very long (TASC D) SFA lesions. The study plans to enrol up to 450 patients, with a focus on including at least 200 women and also features an imaging substudy. Recruitment will involve up to 200 sites, with five-year follow-up.
“The initiation of the PTAB1 postmarket study represents a pivotal moment in our ongoing commitment to advance the treatment of complex peripheral arterial disease [PAD]. Through this study, we aim to further validate the Detour system’s innovative approach to overcoming complex PAD challenges,” expressed Matt Thompson, president and CEO of Endologix.
Thomas S Maldonado, the Schwartz-Buckley endowed professor of surgery in the Vascular Division at New York University Langone Medical Center (New York City, USA), underscored the significance of being the inaugural site to enrol a PTAB patient: “Our privilege of enrolling the first patient in the PTAB1 postmarket 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.”
