
Endologix Shares Pooled Analysis at VIVA Showing Novel DETOUR System Results in Positive Outcomes for Severe PAD Patients With Less-Invasive Technique
11-6-23 (by: Scott Gleason) Endologix has unveiled the outcomes of a pooled analysis of DETOUR1 and DETOUR2 Studies that assessed Percutaneous Transmural Arterial Bypass (PTAB) using the DETOUR System. PTAB with the DETOUR System represents a new approach to managing complex Peripheral Arterial Disease (PAD), allowing physicians to bypass lesions in the superficial femoral artery by creating conduits routed through the femoral vein via a transmural passage, thus restoring blood flow to the leg. This method has proven to be effective for patients with long lesions ranging from 20cm to 46cm in length.
The data examined in the analysis was collected from the DETOUR1 and DETOUR2 studies, both of which were international, multi-center, single-arm prospective trials designed to evaluate the DETOUR System. The studies shared similar inclusion criteria and pre-specified endpoints, including freedom from major adverse events (MAEs) at 30 days, symptomatic deep vein thrombosis (DVT), and length of hospital stay. In the pooled analysis, primary patency was defined as freedom from target vessel revascularization (TVR).
The findings from the analysis of 275 patients were presented at the 2023 VIVA Late-Breaking Clinical Trial Session. 94% of study participants had chronic total occlusions of the superficial femoral artery with average lesion lengths of 31.6 cm. Key results from the analysis included primary patency, defined as freedom from TVR of 79.1% at 1 year and 68.1% at the 2-year mark. Freedom from MAEs within the initial 30 days was 97.8%. Symptomatic DVT was recorded at 3.3%, and the rate of pulmonary embolism (PE) was zero, both sustained through the 2-year follow-up. The average length of hospital stay was 1.3 days.
Dr. Sean Lyden emphasized the clinical effectiveness of this therapeutic approach for addressing lengthy, complex femoropopliteal lesions while also highlighting that PTAB with the DETOUR System delivers results comparable to open surgical prosthetic femoropopliteal bypass. However, it does so without requiring general anesthesia, extended hospital stays, and a high rate of complications.
The study’s outcomes highlight the DETOUR System’s potential to revolutionize the management of complex vascular diseases and offer a less invasive, highly effective alternative to traditional surgical approaches. The ability to improve patient outcomes while minimizing the need for invasive surgery and lengthy hospital stays is a significant development in the field of vascular medicine.