IRVINE, Calif. December 27, 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 Transitional Pass-Through (TPT) Payment for the DETOUR System, effective January 1, 2024.
The TPT Payment was created to facilitate patient access for qualifying new medical technologies that substantially improve the diagnosis or treatment of Medicare beneficiaries. TPT will provide hospitals with additional device reimbursement when the DETOUR System is used for eligible cases in the hospital outpatient setting. Details on the TPT, code C1604, can be found in the January 2024 Update of the Hospital Outpatient Prospective Payment System (OPPS), accessible on the CMS website: here and the Endologix website: here.
Percutaneous Transmural Arterial Bypass (PTAB) with the DETOUR System, an FDA Breakthrough Device, received PMA approval in June 2023. PTAB offers a novel approach to treating complex PAD. The device enables 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.
“Being awarded the TPT designation marks an important milestone in our reimbursement strategy and the commercial launch of the DETOUR System for treating patients with complex PAD. At Endologix, our core mission is to deliver healthcare innovation to improve the lives of patients with vascular disease. With the support from CMS for qualified patients, we eagerly anticipate more patients to benefit from PTAB,” 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 (Abdominal Aortic Aneurysms) System, ALTO® Abdominal Stent Graft System, and the DETOUR™ 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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