FDA Approved Abiomeds SmartAssist Technology for Impella CP

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SmartAssist technology utilizes an optical sensor to inform exact positioning for the device along with providing data regarding pressure on various areas of heart

Impella CP heart pump of Abiomed received expanded FDA premarket approval for its SmartAssist technology on April 2, 2018. The technology 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)

“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.”

The Impella CP is one of several circulatory support devices manufactured by Abiomed. Furthermore, Abiomed has received CE mark approval for the Impella CP with SmartAssist, which allows marketing of the device 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 received its expanded premarket approval. “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.”

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