Abiomed Launches Impella CP With SmartAssist in Europe

August 31, 2019—Abiomed, Inc. announced the launch in Europe of its Impella CP with SmartAssist technology, which is designed to improve patient outcomes with advanced algorithms and simplified patient management. The device was introduced at the European Society of Cardiology’s 2019 congress held August 31–September 4 in Paris, France. It will become available through a controlled rollout process at select sites. The majority of Impella CP heart pumps in Europe will be transitioned to SmartAssist over the next 12 months.

According to Abiomed, the new Impella CP heart pump features a fiber optic sensor that is positioned to measure the placement signal in the aorta, identify pump placement, and enable repositioning without the use of imaging. The advanced sensors also enable the calculation and display of additional physiologic data on the automated Impella controller.

Advances to the Impella forward-flow heart pump technologies and software are designed to improve ease of use and patient management to improve both survival and heart recovery. The system’s weaning algorithms optimize survival and native heart recovery. Real-time displays of critical hemodynamic metrics indicate left ventricular end-diastolic pressure, mean arterial pressure, and cardiac power output.

The SmartAssist sensor allows for precise positioning in the aorta and left ventricle and repositioning in the intensive care unit without needing the catheterization lab or ultrasound imaging. Additionally, the system provides greater hemodynamic support by allowing for sustained peak flows of up to 4.3 L/min (> 85% of a normal cardiac cycle). Finally, the new system provides a faster, simplified Impella console setup in < 90 seconds with fewer connections and reduced steps.

Professor Karim Ibrahim, MD, Head of Cardiology at Klinikum Chemnitz in Chemnitz, Germany, commented in Abiomed’s announcement, “Impella CP with SmartAssist is fast and easy to set up and to manage. The positioning and repositioning of this device is extremely precise thanks to the signal of the optical pressure sensor; its measurement is very reliable. If you have a patient in cardiogenic shock, every minute counts to unload the left ventricle. CP SmartAssist is, in this respect, a tremendous technical innovation that can save essential time.”

After receiving CE Mark approval in 2016 and FDA approval in 2018, the SmartAssist platform has been thoroughly validated for this commercial rollout during a limited market release in Germany and the United States, advised Abiomed.