The current proposal responds to program announcement PA-09-081, which has extended and replaced our Phase I announcement PAS-06-131 "Applications of Imaging and Sensor Technologies for Clinical Aging Research." The purpose of the announcement is to improve imaging methods for measuring age-related changes in regulation of complex physiologic systems, including responses to stimuli or stressors. Our proposal responds to this request through the development and validation of a software platform that enables processing and reporting of noninvasive magnetic resonance imaging (MRI) data related to cardiovascular blood flow and end organ function in elderly patients. The focus of this Phase II application is to identify renal artery stenosis and predict patients that will benefit from renal artery revascularization procedures. It is estimated today that as many as 50% of the elderly now receive unnecessary renal artery revasculization procedures that cost between $7,000-15,000 per procedure. The annual cost of this issue to the US healthcare system is 250-500 million dollars. The focus of this application is to provide a non-invasive, non-contrast, cost-effective method to identify elderly individuals with renal arterial stenosis and then predict which of these elderly would benefit from a renal artery revasculization procedure so as to avoid unnecessary risk associated with these procedures as well as health care expenditures. In Phase I of this application, all of our objectives were met. We developed a software tool, and demonstrated that the tool can rapidly (in 1 to 2 minutes) and accurately visualize arterial segments and measure arterial blood flow. We obtained FDA approval for our Phase I development, and have sold this product to 4 Healthcare providers in the last year. In this Phase II proposal, we will repurpose and further develop the software from our Phase I application to build a renal specific tool called RenalVue/RVQ. This product will include the ability to visualize and display renal angiograms acquired without the administration of contrast, measure blood flow and velocity in the renal arteries, and simultaneously measure renal tissue oxygenation before and after a stress stimulus. This latter capability provides the unique capacity to define kidney viability, which is the determining factor for identifying individuals who could benefit from a renal artery revascularization. At the conclusion of our Phase II program, we will submit a 510k FDA application for our RenalVue/RVQ product. This product will be significant in that it will effectively facilitate the management of renovascular disease while simultaneously reducing health care expenditures in the elderly.

PUBLIC HEALTH RELEVANCE: For the estimated 25 million elderly Americans with cardiovascular disease, our device enables a non-invasive, fast, safe, accurate, relatively inexpensive, magnetic resonance imaging (MRI) process that does not use contrast or x-rays to determine rest and stress blood flow and vascular function throughout the body. This product facilitates the performance of outpatient and inpatient procedures so that MRI flow data can be utilized in a time efficient clinically useful manner for improving cardiovascular health in the elderly. In particular, the focus of this Phase II is to extend the utility of this product for the evaluation of renal artery stenosis and predicting which patients will benefit from renal artery revascularization procedures. Data from this project will be used to obtain FDA approval for a product that will be sold to centers performing MRI.

R42AG030248

2008-05-15

2013-07-31