480 Biomedical’s Stanza™ bioresorbable, self-expanding scaffold (under development) is a proprietary device and delivery system for use in peripheral artery disease (PAD), specifically for treatment of the superficial femoral artery (SFA). More than 10 million people worldwide are estimated to have SFA occlusive disease, a narrowing or obstruction of the arteries in the upper leg restricting blood flow to the lower extremities. The superficial femoral artery is the main artery in the thigh supplying blood to the leg and foot. Atherosclerotic plaque is the primary cause of this arterial wall narrowing.
When blood flow in the SFA is restricted, patients can experience pain and numbness in the legs and feet while walking and at rest. Left untreated, PAD increases the risk of heart attack, stroke, amputation and death. Current treatment of SFA occlusive disease includes exercise, medical therapy, interventional procedures with angioplasty balloons and stents, and vascular surgery.
Minimally invasive interventional procedures are a preferred option for patients not adequately managed on medication alone. The SFA poses particular challenges not addressed by currently available interventional devices. The vessel is subject to a high degree of mechanical force and deformation, which can increase the potential for complications related to permanent metal stents. These complications include stent fracture, persistent inflammation and in-stent restenosis. Should occlusive disease progress within a permanent stent, it can be difficult to re-treat the vessel and restore blood flow.
For more information about peripheral artery disease, visit the American Heart Association website.
With its unique combination of strength, flexibility, drug elution, and bioresorption, the Stanza™ bioresorbable, self-expanding scaffold is ideally suited to the specific challenges of the superficial femoral artery. With a radial stiffness equal to metallic stents, the Stanza™ scaffold can prop open the leg vessel and withstand the mechanical forces that can be exerted on the vessel. Stanza™ is flexible and conforms to the vessel, adapting to leg movement. Bioresorbabilty means no permanent implant is left behind to cause irritation or complications after the scaffold has performed the function of supporting the vessel during the critical healing period. The Stanza™ scaffold resorbs in about one year, leaving no permanent implant behind.
480 Biomedical initiated The STANCE study in 2011 to confirm the mechanics and delivery of the Stanza bioresorbable scaffold. Clinical studies are ongoing to test the drug eluting scaffold in The SPIRIT trial.