CORAFLEX POLYURETHANE PROSTHETIC VALVE PROGRAM

ALTHOUGH PROSTHETIC HEATT VALVES HAVE BEEN IN CLINICAL USE SINCE 1960, A NEED EXISTS FOR A VALVE THAT DOES NOT REQUIRE ANTICOAGULANTS AND HAS A LONG LIFE EXPECTANCY. BIOCONTROL TECHNOLOGY, INC. HAS DEVELOPED A VALVE THAT PROMISES TO MEET THESE CRITERIA. IT RESEMBLES THE HUMAN AORTIC VALVE, OR THE PORCINE OR BOVINE VALVES, BUT IT IS MADE OF BIOCOMPATIBLE, FATIGUE-RESISTANT CORAFLEX POLYURETHANE. THE VALVE IS DESIGNED TO HAVE MINIMAL MEMBRANE STRESS, SHEARSTRENGTH, AND SUBSEQUENT HEMOLYSIS. THE VALVE HAS BEEN TESTED IN A CARDIAC-PULSE DUPLICATOR AND IN DOGS AND HAS DEMONSTRATED FLOW CHARACTERISTICS SIMILAR TO PORCINE VALVES,WHICH DO NOT REQUIRE ANTICOAGULANTS. IN ADDITION, TO PREVENT VALVE CALCIFICATION, THE PROSTHESIS WILL CONTAIN THE ANTICALCIFICATION AGENT, ETHANEHYDROXYDIPHOSPHONATE (EHDP), IN A SLOW-RELEASE FORM (>30 YEARS EXTRAPOLATED DRUG DELIVERY) AS PART OF BOTH THE LEAFLET STRUCTURE AND THE SUPPORT RING. PHASE 1 OF THE RESEARCH PROGRAM WILL CONSIST OF CONTINUED FATIGUE TESTING OF THE CORAFLEX VALVE ON A SPECIALLY DESIGNED HEART-VALVE-FATIGUE TEST SYSTEM. IT PROVIDES DYNAMIC PRESSURE CHARACTERISTICS SIMILAR TO THOSE EXPERIENCED IN THE ACTUAL OPERATING ENVIRONMENT. PHASE 1 WILL ALSO INVOLVE IN VITRO STUDIES OF EHDP CONTROLLED-RELEASE DRUG DELIVERY FROM THE PROSTHESIS. THE SUCCESSFUL COMPLETION OF FATIGUE TESTING AND FORMULATION OF A SUITABLE EHDP CONTROLLED-RELEASE DRUG DELIVERY SYSTEM IN PHASE I WOULD LEAD TO COMPLETE PERFORMANCE AND ANIMAL TESTS IN PHASE II, IN PREPARATION FOR CLINICAL TRIALS.