The Danvers, Mass.-based company said the PMA for the Impella 5.5 with SmartAssist covers treatment for cardiogenic shock for up to 14 days. The new pump is 45% shorter than its predecessor and delivers peak flows of more than six liters per minute, according to Abiomed. The SmartAssist feature is designed to assist in weaning patients off of the device and has a fiberoptic pressure sensor for aiding in deploying and repositioning the pump. The device is also connected, allowing physicians to view the Impella control screen via a HIPAA-compliant website, the company said.
“A minimally invasive, forward-flow, fully unloading heart pump that is designed for surgery is game-changing,” Dr. Mark Anderson, of the Hackensack University Medical Center in New Jersey, said in prepared remarks. “This gives cardiac surgeons a new and potentially better option that can provide the benefits of heart recovery to some of our sickest patients.”
“The Impella 5.5 is designed to give severely ill patients the best chance for recovery of the heart,” added Dr. Hermann Reichenspurner of the University Heart Center Hamburg. “A forward-flow, minimally invasive heart pump that unloads the left ventricle and perfuses the end organs adequately is an ideal tool to help stabilize a patient after cardiac decompensation and give the heart time to rest and recover.”
Abiomed said it plans to release Impella 5.5 in a “controlled rollout” at hospitals with established heart recovery protocols. The device won CE Mark approval in the European Union in April 2018.