IRVINE, Calif. July 18, 2023— Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the first patients underwent Percutaneous Transmural Arterial Bypass (PTAB) using the DETOUR system, since FDA approval of the system was granted. This marks the official start of its U.S. targeted market release.
PTAB with the DETOUR System offers a disruptive, novel approach to treating complex Peripheral Arterial Disease (PAD), enabling physicians to bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein 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.
For the rollout, Endologix collaborated with two healthcare systems known for clinical excellence. PTAB using the DETOUR System was first performed at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and at Salinas Valley Health Medical Center.
“We are delighted to be able to introduce PTAB using the DETOUR System into clinical use”, said Matt Thompson, MD, President, and CEO of Endologix LLC. “The DETOUR System is a pivotal addition to our product portfolio, which now offers differentiated therapies for both abdominal aortic aneurysms and PAD. The successful introduction at these leading institutions underscores our commitment to continuing to innovate on behalf of patients. Broadening our therapeutic profile is a key achievement as we transform Endologix into a leading interventional vascular company.”
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. These products are designed to treat a wide spectrum of vascular disease from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix’s current commercial EVAR (Endovascular Aneurysm Repair) products include the AFX®2 Endovascular AAA (Abdominal Aortic Aneurysms) System and the ALTO® Abdominal Stent Graft System. Endologix is wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy. In April 2021, Endologix completed the acquisition of PQ Bypass, Inc., a privately held medical technology company, adding the DETOUR System and TORUS Stent Graft to the Company’s product pipeline.
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 product components are available in every country. Please consult with your Endologix representative to confirm product availability.
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