The use of microsurgical procedures is increasing, and includes free tissue transfers and/or reconstruction after cancer resection, limb transplantation, breast reconstruction, and traumatic amputation, avulsion, or gunshot injury. Venous congestion is a serious complication of these types of procedures. Replanted tissues can become severely congested, and if uncorrected, tissue death results. Currently, live leeches are used to treat this condition, but are psychologically traumatic to patients, and are often ineffective in preventing tissue death. In SBIR Phase I and II projects, SpectroCon developed new technology for the treatment of venous congestion. AutoFlow is a fully automated medical device. In an animal model, AutoFlow removed excess blood, promoted blood flow in congested tissues, safely contained removed blood, and demonstrated autotransfusion capability. NHLBI supports Competing Continuation Awards of SBIR Phase II grants to improve devices and conduct clinical studies toward approval by a Federal regulatory agency. Accordingly, our overall goals for the Phase II Continuation period are to: (1) Complete regulatory compliance activities with the Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) and toward device approval via a Premarket Approval (PMA) application, and (2) Complete a clinical trial in human patients in which AutoFlow is compared with the standard of care for treatment of venous congestion (i.e. use of medicinal leeches).
Our specific aims are: (1) To ensure compliance with regulatory standards toward the goal of achieving FDA approval of an IDE, and further approval to market AutoFlow via the PMA mechanism;(2) To determine the safety of using AutoFlow in human patients with venous congestion, and (3) To determine efficacy of using AutoFlow in human patients with venous congestion.
These aims are critical for gaining market approval from the FDA for AutoFlow therapy and in establishing the safety and efficacy of AutoFlow, in comparison with medicinal leeches. Achieving these aims will create a large functional divide between use of AutoFlow and medicinal leeches, and will establish AutoFlow as the universally preferred method for the treatment for venous congestion in the marketplace.Project Narrative Because live leeches are less than optimal for treating venous congestion, new technology is needed that will treat this condition more effectively. SpectroCon has developed AutoFlow, a fully automated medical device, because it will be beneficial in restoring function to persons experiencing complications in breast reconstruction, head and neck cancer surgery, and trauma surgery. Effective salvage of amputated limbs, fingers, breasts, or critical tissues of the head and neck will clearly enhance physical, occupational, and vocational rehabilitative potential, as well as speech, swallowing, general appearance, and quality of life.