Newly Proposed In Vitro Test and Evaluation Requirements for Transcatheter Heart Valve Substitutes

The landscape of heart valve substitutes has evolved significantly over the past several years from heart valves implanted surgically via open chest procedures to newly developed heart valve substitutes delivered via minimally invasive transcatheter approaches.  Although detailed guidelines for in vitro testing and evaluations of heart valve prostheses have long been established by the FDA and by ISO for surgically implanted heart valve substitutes, no such requirements currently exist for transcatheter heart valves. 

As part of the ISO 5840 revision effort, work has been underway over the past 2-3 years to define in vitro test requirements for evaluating transcatheter valve performance.  Specific requirements for device durability, frame fatigue, corrosion resistance, and valve hydrodynamics have been developed for transcatheter valve designs, including requirements specific to Nitinol structural components.  These proposed requirements represent a collective effort by experts from academia, industry, and regulatory agencies.  The proposed in vitro tests and analyses defined in the draft ISO document serve as quantitative and qualitative indicators of the performance of the materials and components used in transcatheter heart valve systems.

This presentation will provide an overview of the proposed in vitro test and evaluation requirements for demonstrating safety and performance of transcatheter heart valve substitutes.