Publications
Publications
- February 2025
- HBS Case Collection
Abiomed: Clinical Trials and Tribulations
By: Satish Tadikonda, Faith Robertson and William Marks
Abstract
After receiving 510(k) clearance for the Impella 2.5 device, Abiomed had proceeded to conduct a premarket approval (PMA) process as well to prove clinical superiority, earn greater protection, and extend commercial runway. However, in the middle of the clinical trial required as part of the PMA process, CEO Michael Minogue got word that the independent Data Safety Monitoring Board (DSMB) had called for the early termination of the trial. His 2010 scramble to determine how to proceed had massive implications for the company, requiring the company to publicly disclose the termination of the trial, potentially restart the entire trial, and potentially affect the commercial and regulatory success of the device he was convinced was saving many lives. Minogue had conviction that the DSMB was wrong, but how would he chart a path forward?
Keywords
Corporate Disclosure; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Medical Devices and Supplies Industry
Citation
Tadikonda, Satish, Faith Robertson, and William Marks. "Abiomed: Clinical Trials and Tribulations." Harvard Business School Case 825-096, February 2025.