Endologix Gains New Technology Add-on Payment for DETOUR System

The U. S. Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for Endologix LLC’s DETOUR System, a U.S. Food and Drug Administration-designated Breakthrough Device, as part of its Fiscal Year 2024 Hospital Inpatient Prospective Payment System.

NTAP was created to facilitate patient access for qualifying new medical technologies that substantially improve the diagnosis or treatment of Medicare beneficiaries. As of Oct. 1, CMS will provide hospitals with additional device reimbursement when the DETOUR System is used for eligible cases in the hospital inpatient setting.
 
Percutaneous transmural arterial bypass (PTAB) with the DETOUR System offers a novel approach to treating complex peripheral artery disease (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), those that have already undergone failed endovascular procedures, or those that may be sub-optimal candidates for open surgical bypass.
 
“Receiving the NTAP designation is a testament to the transformative potential of the DETOUR System in treating complex PAD. At Endologix, we are deeply committed to pioneering solutions that drive better patient outcomes. With this added support from CMS for eligible patients, we are excited to see more patients benefit from this novel approach,” Endologix President/CEO Matt Thompson, M.D., said.

The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200mm to 460mm in length with chronic total occlusions (100mm to 425mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature.
 
Endologix LLC is a California-based 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, 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, Calif.