Management of cellular motility and subsequent hyperplasia with Electric Fields (EF) offers the potential to have a significant impact in managing stenosis in a variety of clinical applications including coronary and peripheral arterial stenting, and arteriovenous access in hemodialysis. As a first step towards this goal of active management of stenosis utilizing EF, this proof of concept SBIR Phase I proposal will demonstrate the ability of applied electric fields to mitigate stenosis in an angioplasty injury model. This model creates long-term vascular remodeling associated with neointimal formation in vivo. The proposed preclinical studies will assess the impact of various applied electric fields on neointimal growth following vascular injury in this model system. Effectiveness of the technology will be made by comparing intimal and medial areas of transverse sections of injured arteries in the presence of the electric fields as compared to control /inactive EF electrodes in the same vessel. This initial proof of concept work will provide the basis for future planned studies in more complex model systems, e.g. AV graft models, designed to optimize efficacy.
The results of this Phase-1 SBIR proposal offers the foundation of a disruptive advance in mitigating stenosis in several clinical applications including coronary and peripheral arterial stenting, and arteriovenous access in hemodialysis. In particular, the long term focus of this first application of the EF technology is the huge unmet clinical need associated with hemodialysis vascular access dysfunction (arteriovenous dialysis grafts or fistulae). This unmet clinical need represents the second largest expenditure by Medicare for these hemodialysis patients, next to the hemodialysis treatment itself. The failure rates for graft dysfunction are a direct consequence of stenosis due to intimal hyperplasia at the graft-vein anastomosis, and the current therapeutic interventions have very poor efficacy, are complex and costly.
