Project summarycritical limb ischemia (CLI), the most severe form of peripheral arterial disease (pad) occurs when arterial circulation is insufficient to support the metabolic demands of the tissue

Amputation is often the result. In many diabetic patients, the arterial disease is so diffuse and distal that revascularization success rates are low. Mortality rates for CLI patients are high, at 50% within 5 years and 85% within 10 years. Given the obesity epidemic associated with diabetes, developing new strategies for treating CLI in patients without a revascularization treatment option remains a crucial goal and key opportunity.AVT, an indiana-based small business is developing a new device to treat CLI and other vascular conditions of the extremities. Through a successful phase i, AVT developed a working prototype of its smart pneumatic compression device (PCD). As a continuation of those successful efforts, AVT and its collaborators are proposing the following technical objectives in phase II:continue to consult with DR. Robert mcbane and use pilot data and his expertise to improve AVT's PCD prototype; further develop AVT's main PCD prototype and cuff to maintain efficacy while maximizing benefits – including ease of use in home or clinic; create additional smart features to enhance use and compliance; transfer the PHI prototype to GMI and provide ramp-up for manufacturing for home and clinical sales; and, finallyprepare for FDA passage and regulatory clearance. Once fully developed, this new smart PCD offers an extensive market opportunity as IT can be used to treat multiple conditions with compliance feedback that will aid prescribers' treatment plans and payers' reimbursement validation. The outcome of this phase II funding will be a portable smart (computer controlled), noninvasive therapy option to help heal wounds in-home, or local clinics; especially needed in rural areas where underserved populations have limited access and clinical grade treatments are not available. Patients in rural america suffering from diabetic foot complications (commonly having CLI) are 51% more likely to undergo major amputation and 41% more likely to suffer impatient death. Those that live in poorer regions are 38% more likely to undergo major amputation. AVT's primary objective focuses on increasing patient compliance while reducing healing time, cost, and the need for amputation in comparison with commercially available portable alternatives. Given the successful results of phase i and a continued pilot study at a large midwestern research hospital, AVT believes its smart PCD can meet this objective.