Abiomed announced April 2 its Impella CP heart pump has received expanded FDA premarket approval for its SmartAssist technology. SmartAssist utilizes an optical sensor to inform exact positioning for the device and provide data on left ventricular pressure (LVP), end-diastolic pressure (EDP) and cardiac power output (CPO), according to a press release.
“The ability to view fundamental hemodynamic data such as LVP, EDP and CPO directly on the Impella console provides critical information for clinical decision-making,” said William O’Neill, MD, the medical director of the Center for Structural Heart Disease at Henry Ford Hospital in Detroit. “Additionally, access to data and real-time pump position improves efficiency for nurses and physicians in the ICU and CCU.”
Abiomed has also received CE mark approval for the Impella CP with SmartAssist, allowing the device to be marketed in the European Union. According to the company, more than 60 engineering reports and full technical specifications were submitted to the FDA before the system gained its expanded premarket approval.
The Impella CP is one of several circulatory support devices manufactured by Abiomed.
“Abiomed would like to thank our physicians, technologists and nurses for their feedback on how to improve the Impella platform,” said Abiomed CEO Michael R. Minogue. “Our scientists, engineers and clinical team are always looking for ways to improve our ease of use, training and clinical performance. Through innovation and research, our clinical team will utilize SmartAssist to help our customers achieve our goal to improve outcomes and enable heart recovery for every patient.”