INFINITE-US Trial

A Study to Evaluate the Safety and Efficacy of the BlueLeaf® Endovenous Valve Formation System for the Restoration of Deep Venous Competence in Patients with Symptomatic Chronic Venous Insufficiency (CVI).

Do you have patients with symptomatic CVI? Chronic venous insufficiency (CVI) with incompetence of the deep venous valves affects 20% of the adult population. Signs of CVI include edema, telangiectasia, reticular or varicose veins, and skin changes including ulceration. Symptoms caused by CVI include chronic pain, edema, skin hyperpigmentation, dermatoliposclerosis, and ultimately ulceration in some patients.

The most frequent causes of CVI are from primary abnormalities of the venous wall and vein valves, or secondary changes resulting from previous venous thrombosis. For many patients suffering from primary or secondary CVI, these painful symptoms are caused by failed venous valves in the legs, and subsequent static columns of blood in the lower extremities that cannot move back to the heart.

Current methods of treating CVI include compression therapy and open surgical repair, but both of these methods are imperfect. Compression therapy requires strict adherence by patients, and surgery is difficult and expensive. The BlueLeaf® Endovenous Valve Formation System is the first non-surgical reconstructive potential treatment for CVI, and uses conventional, less invasive interventional techniques for vein access. The device is intended to form new tissue leaflets within the vein walls without the use of a permanent vascular implant. The BlueLeaf procedure typically requires a single overnight stay in the hospital.