Novel pneumatic compression device for CLI

Advanced VascularTherapies, (AVT), INC. proposes to further develop a portable pneumatic compression device (PCD) in SBIR Phase I, for sales after ramp-up and FDA clearance in SBIR Phase II. The PCD will be optimized for the critical wound healing needed to prevent amputation for patients suffering from arterial insufficiencies that can be used in the patient's home, providing access not currently available, especially in rural areas. This R&D addresses the portable/remote wound-healing need prominent among the population of patients suffering from arterial insufficiency (often diabetics), exploiting novel blower technology, and cuff design applied to a PCD. Results from an on-going physician-sponsored pilot at a major Midwest Clinic, completely independent of AVT, will be analyzed to inform the design of AVT's next proposed PCD. The treatment approach, measuring dermal perfusion using Laser Doppler Perfusion and oxygen tension to determine efficacy, examines patients before, during, and after use of the AVT PCD.AVT's goals are: 1) Increase patient compliance while reducing healing time, cost, and the need for amputation in comparison with commercially available portable alternatives. 2) Provide close, safe access to treatment to patients that would have to go great distances to a limited number of large clinics to heal otherwise. These include Indian reservations, VA and low income patients.The R&D will be carried out in collaboration, with Dr. Robert D. McBane and Dr. Steven J. Kavros (AVT Medical Director).