SHAPE MEMORY MEDICAL INC — Department of Health and Human Services SBIR Phase II: NIBIB

Description

ABSTRACT Venous insufficiency VI is the cause of more than annual hospitalizations in the U S and accounts for more than $ billion in annual healthcare expenses accounting for approximately 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 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 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 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 and day follow up and local and system toxicity At the culmination of this work all studies necessary for submission to the FDA for k clearance will be completed PROJECT NARRATIVE Venous insufficiency VI causes more than hospitalizations every year in the United States accounting for approximately $ billion in annual healthcare expenses VI occurs when veins are weakened and bulge outward When this happens it can cause persistent pain that lasts more than months making it difficult to walk or even stand for prolonged periods of time The proposed technology addresses these issues by permanently blocking flow to the diseased veins This technology provides better long term healing a lower risk of repeat procedures and reduces the cost of current treatments by approximately