Background
In October 2022, Abiomed, a leading provider of medical technology focused on mechanical circulatory support heart and lung recovery, announced that the U.S. Food and Drug Administration (FDA) accepted and closed all of the post-approval study reports related to the pre-market approvals (PMA) for the Impella heart pump. The announcement marked a significant regulatory milestone, affirming that the totality of Impella data collected demonstrate that the Impella heart pumps are safe and effective for patients with cardiogenic shock, high-risk percutaneous coronary intervention, post-cardiotomy cardiogenic shock, cardiogenic shock in the setting of myocarditis or cardiomyopathy, and right heart failure.
The FDA typically requires post-approval studies for a medical device that receives a PMA. Such studies require high-quality prospective data to confirm that the clinical evidence used for the PMA is 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.
Upon reaching the completion of these studies, Abiomed sought out a highly experienced partner to ensure that the post-marketing Impella study data would hold to FDA standards. In June 2019, Abiomed contracted Bioforum to help with the completion of the post-approval studies, with the potential of becoming the preferred data management partner of Abiomed.
This initial collaboration gave Abiomed the opportunity to work with a data-focused CRO and experience the benefits of partnering with Bioforum. Pleased with the superior quality and attention to details with which Bioforum handled the data and the new partnership, Abiomed engaged Bioforum for a complete suite of data management services.
Challenge
Abiomed’s studies are highly complex and many included several protocol versions and sub-studies, as well as intricate scenario flows. Supporting Abiomed required Bioforum to maintain a very tight timeline and in some cases, migrate data from previous databases, all while striving to avoid manual work, maintain compliance, and minimize any risks of data loss.
Solution
Given the clinical complexity of the studies, previous data entry, and the need for robust technical solutions, Bioforum used 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 improved the experience for study teams at the clinical trial sites and increased overall site compliance, enabling Abiomed to meet key deadlines.
Results
All projects were successfully completed and delivered as promised. Bioforum averaged eight weeks to complete the work on each of the databases, with some delivered ahead of schedule. Additionally, Bioforum created comprehensive Case Report Form (CRF) libraries, significantly reducing the need for database amendments and accelerating CRF completion time, which increased site compliance.
Following the successful completion of the pilot project, Abiomed has enlisted the support of Bioforum across a range of data management projects. These include new Impella database builds as well as statistical programming and data visualization support. All in all, past and current activities reflect the long-term strategic partnership between Abiomed and Bioforum.
