ASTM F3666-25

1.1 This guide is intended as a resource for individuals and organizations involved in the development, production, delivery, and regulation of tissue engineered medical products (TEMPs) intended for use in the repair and/or replacement of heart valves. This guide is intended for use related to the in vitro assessment of TEMP heart valves.

1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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.