Endologix LLC announced results from a pooled analysis of DETOUR1 and DETOUR2 Studies evaluating Percutaneous Transmural Arterial Bypass (PTAB) with 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 conduits 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).

Data were aggregated from DETOUR1 and DETOUR2, both of which were prospective, single-arm, multi-center, international studies designed to evaluate the DETOUR System. Inclusion criteria and pre-specified endpoints were similar. Both studies utilized imaging core lab and independent adverse event adjudication.

Endpoints included freedom from MAEs through 30 days, symptomatic DVT, and length of stay. For the pooled analysis, primary patency was defined as freedom from target vessel revascularization (TVR). The results from the 275 pooled patients were presented at the 2023 VIVA Late-Breaking Clinical Trial Session by one of the study?s principal investigators, Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic?s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute.

The presented results included the following: Primary patency, defined as freedom from TVR, was 79.1% at 1-year and 68.1% through 2 years. Freedom from MAEs through 30 days was 97.8%. Clinical success rate was 92.9%, 96.0%, and 95.3% at 30 days, 1 year and 2 years, respectively.

Symptomatic DVT was 3.3% and PE rate was 0%, respectively through the 2-year time point. Average length of hospital stay was 1.3 days. 94% of the patients (94%) had chronic total occlusions of the SFA, with a mean lesion length of 31.6cm.