Best Practices for Interventional Cardiovascular Medical Device Trials

Heart disease is the leading cause of death worldwidei , and the global cardiac medical devices market could expand to reach $65.6 billionii by 2015, due to aging populations and the prevalence of heart disease, stroke and diabetes. Significant advances in technologybased treatments continue, and bringing interventional cardiac devices to market is big business – and one that is complex. Sponsors 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. Working with an experienced medical device clinical research organization (CRO) such as Novella Clinical can ensure sponsors consider and confidently address these factors with expertise and efficiency. This paper addresses the four clinical trial aspects Novella Clinical considers most critical for medical device developers seeking to enter the US market with implantable cardiovascular devices. These factors are regulatory requirements, reimbursement strategy, clinical challenges and vendor selection.