Standard Guide for Characterization and Assessment of Heart Valve Tissue Engineered Medical Products (TEMPs)

Abstract

4.1 Valve replacement procedures due to valvular heart disease are performed annually as a result of structural deterioration, calcification, tissue overgrowth, and/or thromboembolism. Conventional therapies provide major improvements in cardiac function and life expectancy but have significant limitation and require replacement surgery or transcatheter valve replacement and/or repair within 15 to 20 years, particularly for pediatric patients who outgrow their heart valve implants. 4.2 TEMPs may be used with the intent of enhancing patient outcomes by improving the biological repair and/or reconstruction, assuming the mechanical loads at the repair site, allowing growth of the TEMP with the patient, or combinations of these mechanisms. 4.3 Clinical evidence of improved patient outcomes may include increased percentage of successful interventional procedures (surgical and/or transcatheter), shorter recovery time after intervention, fewer or no repeat interventions, improved functionality after intervention, or any combination of these.