TCT 2024: Johnson & Johnson’s Abiomed Successfully Completes Pivotal Study for Innovative Shrinkable Heart Pump, Impella ECP

Pivotal Study Success:
Johnson & Johnson's Abiomed has successfully completed a pivotal study for the Impella ECP heart pump, demonstrating its safety and efficacy for use in high-risk percutaneous coronary interventions (PCI).

Impella ECP Design:
The Impella ECP features a 9Fr size at insertion, expanding to 21Fr after insertion to provide circulatory support and left ventricular unloading for high-risk PCI. This design allows for small bore access and closure techniques.

Study Outcomes:
The study, which enrolled 256 patients at 18 U.S. sites, reported a 6.3% rate of major adverse cardiac and cerebrovascular events (MACCE) at 30 days, significantly below the predefined performance goal.

Closure Techniques:
Operators used an 8Fr Angio-Seal as the first closure method in 70% of patients, achieving a 92% success rate.

Next Steps:
Johnson & Johnson plans to submit Impella ECP to the FDA for approval, following the successful completion of the pivotal study.

Clinical Research Commitment:
Abiomed has invested over $850 million in clinical research over the last five years, with seven completed FDA studies and five post-market approval studies validating the safety and efficacy of Impella heart pumps.