Introduction

Although balloon valvotomy for the treatment of rheumatic mitral stenosis was one of the first successful uses of transcatheter therapy for valvular heart disease (VHD), transcatheter treatment for mitral and tricuspid regurgitation is relatively new to the VHD field.  As such, a large number of devices are being tested of which only a few will likely reach clinical practice.  Below is the sequence of steps in the pathway to  clinical use that such devices must follow to become approved  therapies:

— Device design

— Preclinical testing

— Assessment of appropriate safety and efficacy endpoints by which device success will be judged

— Consultation for regulatory authorities regarding pathway to approval

— Stages of clinical testing

— Approval

— Strategies for reimbursement

The International Society for Cardiovascular Translational Research convened experts from industry, the Food and Drug Administration, clinical trials, society guidelines, and third-party payers to discuss these issues in the sections that follow.