The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go?

Performance of early feasibility studies in the United States can advance the goal of evaluating the safety and effectiveness of new devices aimed at unmet clinical needs and facilitating earlier access for U.S. patients to new technology.

Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States.

Initial clinical studies of new medical technologies involve a complex balance of research participant benefits versus risks and costs of uncertainty when novel concepts are tested. The Food and Drug Administration Center for Devices and Radiological Health has recently introduced the Early Feasibility Study (EFS) Program for facilitating the conduct of these studies under the Investigational Device Exemption regulations. However, a systematic approach is needed to successfully implement this program while affording appropriate preservation of the rights and interests of patients.

Transcatheter valve therapy registry is a model for medical device innovation and surveillance.

Heart valve diseases are increasingly prevalent, especially in people older than age seventy. Many of these elderly people have other comorbid conditions, making them poor candidates for surgical treatment of heart valve diseases. Since 2011 such patients have been eligible to receive new nonsurgical heart valve treatments approved by the Food and Drug Administration (FDA) and covered by Medicare.

Medicare coverage: engaging on evidence.

Experience tells us that many developers of innovative technologies fail to anticipate the evidentiary needs of insurers, particularly of Medicare. Some assume that Medicare payment begins pro forma upon approval or clearance by the US FDA with little regard to the distinct role of the Centers for Medicare & Medicaid Services (CMS). We offer our own suggestions, hoping they will lead to mutually satisfying discussions as we consider coverage of regenerative medicine technology.