Commitment to Research

Over the last five years, the company has invested more than $850 million on clinical research. Abiomed has seven completed FDA studies and five post-market approval studies that validate Impella® heart pumps are safe and effective for high-risk PCI, cardiogenic shock, and right heart failure. Impella heart pumps are included in 13 clinical guidelines and more than 1,200 peer-reviewed clinical publications.

Abiomed is committed to performing randomized controlled trials (RCT) to demonstrate the safety and efficacy of Impella heart pumps. Abiomed sponsored the landmark PROTECT II RCT and has attempted or sponsored eight RCTs, including the ongoing DanGer Shock RCT, for Impella heart pump use in the cardiogenic shock patient population. Abiomed, in agreement with the FDA, is conducting a pivotal, multi-center, prospective, randomized controlled trial, STEMI DTU, comparing unloading with delayed reperfusion to the current standard of care (immediate reperfusion without a LVAD assist device).

In addition, Abiomed is sponsoring the PROTECT IV RCT and the upcoming RECOVER IV RCT. The intent of PROTECT IV is to leverage and validate the best practices for treating high-risk PCI patients learned from the cVAD Study, IQ Database and real-world data collected since the completion of the PROTECT II RCT. RECOVER IV will assess whether Impella pre-PCI is superior to PCI without Impella in patients with AMI cardiogenic shock.