DVX, LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant PAD is a widely prevalent condition affecting of the Medicare population Endovascular procedures such as angioplasty stent are the usual initial surgical procedure close to a million were performed last year Unfortunately many of these procedures fail within a few years In fact less than half of such procedures are successful at two years However some endovascular repairs endure for many years This suggests that with improved technique it may be possible to extend the longevity of most rather than some of these procedures with significant benefit to the millions of patients and health care system It is a well accepted principle of vascular surgery that good blood flow keeps repaired vessels healthy and poor flow leads to early failure Present endovascular procedures employ a subjective method of assessing the post procedure blood flow We propose using a newly developed ultrasound system specifically designed to be used during endovascular procedures to measure the changes in blood flow Our hypothesis is that by measuring the blood flow during endovascular procedures and following the outcome for these patients we can develop criteria for the flow needed to achieve long term repair Measuring flow with the new system during the procedure can then guide treatment so that long lasting repair by endovascular procedures becomes the norm rather than the exception In Phase I we propose establishing the new instrumentandapos s accuracy and reliability for measuring blood flow before during and after the endovascular intervention Milestones for Phase I include showing that for a consecutive run of patients the instrumentandapos s results are consistent with other measures of flow such as duplex Doppler and ABI demonstrating that the new instrument can be used easily in the endovascular procedure room and confirming that the instrumentandapos s cost is low enough to be widely used If Phase I is successful in Phase II the instrument will be used to measure changes of flow produced during endovascular procedures for a large cohort of patients By correlating the outcomes of these procedures with the flows measured during the procedure criteria for a successful procedure can be determined Treatment will then be guided by flow measurements and endovascular treatment can become more successful a boon to patients and the health care system PUBLIC HEALTH RELEVANCE Endovascular procedures are the usual treatment for the close to a million patients per year who need surgery for their PAD At present most of these vascular repairs fail within a few years The proposed research is to develop an instrument that will allow measurements during the endovascular procedure that will result in improved longevity for repaired vessels