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. Impella is included in eight clinical guidelines and more than 550 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 90,000 Impella cases from more than 1,100 U.S. centers. The cVAD Study, which is an IRB approved, prospective study includes more than 5,000 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 Dan-Ger Shock RCT, for Impella use in the cardiogenic shock patient population. Abiomed, in agreement with the FDA, will move forward with a pivotal, multi-center, prospective, randomized controlled trial comparing unloading with delayed reperfusion to the current standard of care (immediate reperfusion without Impella).
Through the cVAD Study, the Impella Quality (IQ) Database, on-going FDA pre- and post-market approval studies, and 24x7 clinical support, Abiomed will continue to support clinical research and collect real-world data to improve patient outcomes.