Shape Memory Polymer Vascular Occlusion Device for the Treatment of Venous Insufficiency Phase II

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ABSTRACT Venous insufficiency (VI) is the cause of more than 500,000 annual hospitalizations in the U.S. and accounts for more than $1 billion in annual healthcare expenses, accounting for approximately 2% of the entire healthcare budget. VI occurs when the valves within veins are weakened and can no longer prevent backflow and blood pooling. As a result, the vein dilates and if left untreated can cause persistent abdominal pain, infertility, and even ulcer formation. To alleviate the symptoms of VI, physicians aim to permanently exclude the diseased vessel from systemic flow. The current gold standard of treatment is the implantation of platinum embolic coils combined with a detergent injection, known as sclerotherapy, which chemically burns the endothelium of the vessel and causes scar formation within the vein. However, up to 15% of patients experience recanalization, or the restoration of blood flow through a previously treated vessel. This often requires the patient to undergo a second, or even third treatment, to permanently occlude the vein. Treatments can also require the implantation of up to 16 coils, which creates prohibitive device costs for treatment facilities, and increased radiation exposure for the patient. The proposed project outlines the continued development of a shape memory polymer (SMP) foam peripheral embolization device (PED) to treat complications associated with VI. The PED will provide rapid, complete occlusion of the refluxing veins with minimal risk of device dislocation, vessel rupture, and damage to surrounding tissues. The realm of treatable veins with VI will also be extended by the material properties of the PED and the ability to be easily delivered to tortuous vessels. Benchtop device verification studies will be performed to ensure the proposed device has adequate mechanical strength, requires minimal force for advancement through the catheter, and the SMP foam is securely attached to the PED to prevent thromboembolism. The biocompatibility of the PED will also be extensively evaluated through ISO 10993 studies typically performed on this class of devices. Finally, the PED will be delivered to twelve preclinical animals and analyzed for ease of delivery and navigation, device migration, time to occlusion, recanalization at 30 and 90-day follow up, and local and system toxicity. At the culmination of this work, all studies necessary for submission to the FDA for 510(k) clearance will be completed.