Abiomed is committed to investing in clinical research to provide the best possible outcomes for our patients. Over the last five years, the company has invested more than $100 million on clinical research. Abiomed has 7 completed FDA studies and 5 post-market approval studies that validate Impella® as safe and effective for Protected PCI, cardiogenic shock, and right heart failure. Impella is included in 10 clinical guidelines and more than 780 clinical publications.
Abiomed is improving outcomes by leading in clinical research and sharing best practices with the most comprehensive data collection studies in the field. The Impella Quality (IQ) Database includes real-world data from more than 150,000 Impella cases from more than 1,400 U.S. centers. The cVAD Study®, which is an IRB approved, prospective study, includes more than 6,500 patients.
Abiomed is committed to performing randomized controlled trials (RCT) to demonstrate the safety and efficacy of Impella. Abiomed sponsored the landmark PROTECT II RCT and has attempted or sponsored eight RCTs, including the ongoing DanGer Shock RCT, for Impella use in the cardiogenic shock patient population. Abiomed, in agreement with the FDA, has also begun a pivotal, multi-center, prospective, randomized controlled trial, STEMI-DTU™, comparing unloading with delayed reperfusion to the current standard of care (immediate reperfusion without Impella).
In addition, Abiomed is sponsoring two upcoming randomized control trials for Impella, PROTECT IV and RECOVER IV. 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 Randomized Controlled Trial. RECOVER IV will assess whether Impella pre-PCI is superior to PCI without Impella in patients with AMI cardiogenic shock.
Abiomed will continue to support clinical research and collect real-world data to improve patient outcomes through the cVAD Study and the Impella Quality (IQ) Database, in addition to on-going FDA pre- and post-market approval studies, and 24x7 clinical support.