Best Practices For Interventional Cardiovascular Medical Device Trials

Heart disease is the leading cause of death worldwide, and the global cardiac medical devices market could expand to reach $65.6 billion by 2015, due to aging populations and the prevalence of heart disease, stroke, and diabetes. Significant advances in technology-based treatments continue, and bringing interventional cardiac devices to market is big business — and one that is complex. Companies seeking to bring implantable cardiovascular products to market, whether they are stents, valves, pacemakers, ventricular assist devices, or other novel technologies, face several significant factors in designing and conducting clinical trials. This paper addresses the four aspects of implantable cardiovascular device clinical trials that Novella Clinical considers most critical: regulatory requirements, reimbursement strategy, clinical challenges, and vendor selection.

Image credit: “Open Stent.” Lenore Edman. 2013. CC BY 2.0: https://creativecommons.org/licenses/by/2.0/