Minnesota HealthSolutions Corporation — Department of Health and Human Services SBIR Phase II: NIA

Description

Project Summary/Abstract We propose the development of a novel balloon angioplasty inflation device for improving the safety and efficacy of balloon angioplasty. Atherosclerosis is associated with coronary artery disease, ischemic stroke and peripheral arterial disease. Percutaneous balloon angioplasty, often in conjunction with stent device deployment, has been associated with prolonged survival, increased quality of life and extended delay of restenosis. There exists great enthusiasm for percutaneous interventions to resolve atherosclerotic symptoms. Balloon inflation devices on the market do not adequately consider the molecular composition of the artery nor do they consider elasticity differences between arterial beds. The proposed project explores a novel technique to promote improved inflation performance during balloon angioplasty, resulting in less stress on the artery wall to achieve resultant luminal area. A production prototype device will be developed and evaluated.Project Narrative Atherosclerosis is the leading cause of vascular disease, which accounts for 38% of all deaths in North America. Coronary artery disease is the leading cause of death from atherosclerosis, with over 500,000 deaths per year in the US alone. Peripheral artery disease affects more than 200 million persons worldwide, including at least 8.5 million persons in the United States, and is associated with high rates of cardiovascular events and death as well. Percutaneous intervention via balloon angioplasty is a common treatment for atherosclerosis. In coronary artery treatments, up to 30% of all conventional procedures result in angiographically significant coronary dissection. The most significant risk factor for perforation is oversizing the balloon diameter for the artery under treatment. We propose to develop a novel device to improve the safety and efficacy of balloon angioplasty.