INTRAVASCULAR GRAFTING DEVICE

THIS RESEARCH WILL CONTINUE THE DEVELOPMENT OF A NEW DEVICE TO FACILITATE THE REPLACEMENT OF AORTIC ANEURYSMS. THE DEVICE FOR PERFORMING THE GRAFTING WILL BE INTRODUCED FROM A PERIPHERAL ARTERIAL SITE, SO THAT THE MAJOR BODY CAVITIES (CHEST AND ABDOMEN) WILL NOT BE ENTERED FOR GRAFTING PURPOSES, THUS DECREASING THE MORBIDITY AND MORTALITY ASSOCIATED WITH THESE PROCEDURES. THE GRAFTING AND REPLACEMENT OF THE ANEURYSMAL PORTION OF THE AORTA WILL TAKE PLACE WITHIN THE EXISTING VESSEL. WITH THE RAPID INCREASE OF THE OLDER AGE GROUP IN THE U.S. POPULATION, THE PROBLEM OF AORTIC ANEURYSMS WILL ALSO INCREASE. THE AVAILABILITY OF SUCH AN INTRAVASCULAR GRAFTING DEVICE COULD REVOLUTIONIZE THE WAY AORTIC ANEURYSMS ARE TREATED. COMMERCIAL APPLICATION IS READILY APPARENT AS 100,000 AORTICSURGICAL PROCEDURES ARE PERFORMED ANNUALLY. PHASE I FUNDS WOULD ASSURE THE COMPLETION OF THE DESIGN AND TESTING OF THE INTRAVASCULAR GRAFTING DEVICE. DURING PHASE II, THE DEVICE WILL BE SUBMITTED TO THE FOOD AND DRUG ADMINSTRATION (FDA) FOR APPROVAL TO DO HUMAN TESTING. SUBSEQUENT FDA APPROVAL WILL BE SOUGHT FOR USE OF THE DEVICE TO REPLACE THORACIC AORTIC ANEURYSMS.