Publications
Publications
- February 2025
- HBS Case Collection
Abiomed: A Change of Heart
By: Satish Tadikonda, Faith Robertson and William Marks
Abstract
After acquiring Impella CardioSystems AG in May 2005, Abiomed Inc., a company focused on cardiac care, ran into a dilemma. Its Impella 2.5 device was approved for use in the European Union, but CEO Michael Minogue had seemingly bet the company's future on the ability to quickly get the device regulatory clearance in the U.S. by the FDA. Doing this would require the FDA agreeing to let the device be cleared by the 510(k) pathway, as opposed to the much more complex premarket approval (PMA) process. After submitting the 510(k) request to the FDA in 2007, Abiomed was told they must proceed instead by the PMA process, meaning patients could not widely access the life-saving device for potentially many years, and cutting a major revenue source for Abiomed that was needed to justify the acquisition. Now Minogue must decide what to do and whether to fight the FDA or acquiesce and find other ways to keep the company going.
Keywords
Mergers and Acquisitions; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Business and Government Relations; Medical Devices and Supplies Industry; European Union; United States
Citation
Tadikonda, Satish, Faith Robertson, and William Marks. "Abiomed: A Change of Heart." Harvard Business School Case 825-011, February 2025.