Wednesday, July 19, 2023
Endologix, a privately held global medical device company specializing in innovative treatments for vascular disease, has announced the successful implementation of the DETOUR™ System on its first group of patients. The system received FDA approval and offers a novel approach called Percutaneous Transmural Arterial Bypass (PTAB) for the treatment of complex Peripheral Artery Disease (PAD). By utilizing stents guided through the femoral vein, physicians can bypass lesions in the superficial femoral artery, effectively restoring blood flow to the patient's leg.
This method is particularly beneficial for patients with long lesions (ranging from 20cm to 46cm), those who have experienced failed endovascular procedures, or individuals who may not be suitable candidates for open surgical bypass. To introduce this groundbreaking system, Endologix collaborated with renowned healthcare systems known for their excellence in clinical practice, including the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at the Cleveland Clinic and the Salinas Valley Health Medical Center.
The DETOUR System represents a significant addition to Endologix's portfolio, expanding their therapeutic options for both abdominal aortic aneurysms and PAD. This successful introduction at leading medical institutions further demonstrates the company's commitment to innovation and delivering improved outcomes for patients. Endologix's objective of broadening their therapeutic profile contributes to their vision of becoming a leading provider of interventional vascular solutions.
The DETOUR System is indicated for percutaneous revascularization in patients with symptomatic femoropopliteal lesions, ranging from 200mm to 460mm in length, featuring chronic total occlusions (100mm to 425mm) or diffuse stenosis greater than 70%. It is designed for patients who may not be ideal candidates for surgical or alternative endovascular treatments. However, it is important to note that the DETOUR System is contraindicated for individuals with a distal common femoral artery (CFA) diameter less than 7mm, increased risk of deep vein thrombosis (DVT), untreated flow-limiting aortoiliac occlusive disease, insufficient patent single vessel tibial runoff to the ankle, known coagulopathy or bleeding disorders that cannot be medically managed, hypersensitivities or allergies to certain substances, as well as contraindications to specific medications or contrast media that cannot be managed medically.
Source: businesswire.com
