IRVINE, Calif. September 7, 2023— Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announces that the U. S. Centers for Medicare & Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) for the DETOUR System, an FDA-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. Beginning October 1, 2023, 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 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,” said Matt Thompson, MD, President, and CEO of Endologix.
Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes a variety of products in various stages of development that are 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 DETOURTM System, are designed to 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, California. To learn more about Endologix, please visit https://www.endologix.com/.
INDICATIONS FOR USE:
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.
The DETOUR™ System is contraindicated in patients with:
- A distal common femoral artery (CFA) <7 mm in diameter.
- Increased risk of deep vein thrombosis (DVT), such as patients with a recent history of DVT, thrombophilia, and disseminated malignancy.
- Untreated flow-limiting aortoiliac occlusive disease.
- Lack of patent single vessel tibial runoff to ankle.
- Known coagulopathy, bleeding diathesis, or thrombocytopenia that cannot be medically managed.
- Known hypersensitivities, allergies or contraindications to: Nitinol; PTFE; aspirin; heparin; antiplatelet; anticoagulant or thrombolytic therapy; or contrast media that cannot otherwise be medically managed.
Refer to Instructions for Use for more information concerning Indications, Contraindications, Specific Anatomic Considerations, Warnings, Precautions, and Adverse Events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
NOTE: Not all products are available in every country. Please consult with your Endologix representative to confirm product availability.
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