How A Long-Term Data Services Partnership Drives Efficiency For A Medical Device Trial Sponsor

Several years ago, Abiomed, a leading provider of medical technology focused on mechanical circulatory support heart and lung recovery, was conducting pre-market approvals (PMA) for its Impella heart pump. To receive a PMA, the U.S. Food and Drug Administration (FDA) typically requires post-approval studies, affirming the industry that a medical device is safe and effective for patients. For this device specifically, Abiomed needed to show that its Impella heart pump would be useful for patients experiencing cardiogenic shock, high-risk percutaneous coronary intervention, post-cardiotomy cardiogenic shock, cardiogenic shock in the setting of myocarditis or cardiomyopathy, and right heart failure.

To meet these requirements, Abiomed needed high-quality prospective data to confirm that the clinical evidence used for the PMA could be replicated in a broad, real-world population of patients. Over the course of seven years, following the PMA approval by the FDA, Abiomed completed five post-approval studies for Impella across 46 sites, enrolling a total of 1,830 patients. In 2019, Abiomed partnered with Bioforum to help with the completion of the post-approval studies and to ensure that data met FDA regualtions.

Discover how Abiomed was given access to innovative and comprehensive programming solutions to reduce the need for manual data entry and to enhance the clinical trial database usability and speed. These efforts not only improved the experience for study teams at the clinical trial sites, but they also increased overall site compliance, enabling Abiomed to meet key deadlines.