Successful Development and Regulatory Approval of Replacement Cardiac Valves

Abstract

Medical devices, particularly those for cardiac valves, are rapidly advancing and changing the medical field. Progress has been demonstrated by improved less-invasive surgical techniques for valve replacement to total transcatheter technologies. These medical device advances allow physicians to help more patients quicker and more efficiently. The field of cardiac device development can be considered as relatively new, beginning in the early 1950s, and yet today newer technologies in this field are presented at ever increasing rates.

The surgical or device advances seen within the medical community generally come from an unmet clinical need. In some ways, physicians are unable to treat (or are at best ineffectively treating) certain types of patients in this aging society. Motivated by these needs, medical device designers—scientists, physicians, patients, or simply individuals with good ideas—choose to undergo the rigorous yet rewarding path of medical device development.

In general, the development path follows a certain route, from device conception, intellectual property generation, and testing to regulatory approval. Since cardiac medical devices are created to help patients, they must also undergo stringent testing for durability, biocompatibility, and manufacturability. To complete these assessments, both animal and clinical testing can be utilized, especially with regard to valve replacement devices. Once an adequate amount of data pertaining to the safety and efficacy of the device has been collected, it will then be sent to a regulatory body to gain approval to market the device.