Endologix Releases Pooled Analysis of DETOUR Studies

Endologix LLC has 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).

“We are pleased to present the combined results of the DETOUR1 and DETOUR2 Studies. The data are congruent between the studies and strengthen our confidence in the transformative potential of the DETOUR System,” Endologix President/CEO Matt Thompson, M.D., said. “The DETOUR System offers a compelling alternative for addressing long, complex femoropopliteal lesions. As we look ahead, we are eager to bring PTAB using the DETOUR System to patients with complex PAD.”
 
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
 
Results* from the 275 pooled patients indicated:

• Primary patency, defined as freedom from tricuspid valve repair, was 79.1% at one year and 68.1% through two years.
• Freedom from major adverse events through 30 days was 97.8%.
• Clinical success rate was 92.9%, 96%, and 95.3% at 30 days, one year and two years, respectively.
• Symptomatic DVT was 3.3% and PE rate was 0%, respectively through the two-year time point.
• Average length of hospital stay was 1.3 days.
• Ninety-four percent of the patients (94%) had chronic total occlusions of the SFA, with a mean lesion length of 31.6cm.

“These results not only demonstrate the clinical utility of this therapeutic strategy in managing long complex femoropopliteal lesions but also highlight that PTAB with the DETOUR System achieves similar results to open surgical prosthetic femoropopliteal bypass without the need for general anesthesia, long length of stay, and high rate of complications. We eagerly await more comprehensive data from broader real-world settings to further corroborate these findings,” stated Dr. Sean Lyden, chairman of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute.
 
Endologix LLC is a California-based, global medical device company developing therapies for interventional vascular disease treatment. Endologix’s therapeutic portfolio includes numerous products in various stages of development 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 DETOUR System, are designed to treat various 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, Calif. 

*Lyden et al. Safety and Performance of percutaneous Transmural Femoropopliteal Bypass with the DETOUR System: Pooled analysis of DETOUR1 and DETOUR2. VIVA 2023