FDA Approves Abiomed's Impella CP With SmartAssist and Optical Sensor

April 2, 2018—Abiomed, Inc. announced that it has received US Food and Drug Administration (FDA) premarket approval for its Impella CP heart pump with SmartAssist, which utilizes an optical sensor. Abiomed will launch the Impella CP with SmartAssist over the next fiscal year through a controlled rollout at hospitals with established heart recovery protocols. A simple upgrade to Abiomed’s existing installed base will be performed on the routine service cycle. The company has previously received CE Mark approval in the European Union to market Impella CP with SmartAssist.

According to Abiomed, the device's advances are designed to improve patient management, productivity, and ease of use. The Impella CP with SmartAssist includes the following features:

• Simplified patient management with advanced software. A new optical sensor improves understanding of real-time, exact positioning for the Impella heart pump and allows for repositioning without the need for imaging equipment.
• Integration of clinical data informatics on the Impella console. This provides real-time informational displays of left ventricular pressure (LVP), end-diastolic pressure (EDP), and cardiac power output (CPO).
• Ease of use and faster setup with fewer steps and connections that simplifies patient management for physicians, catheterization lab staff, and intensive care unit staff. New steps reduce start time by 15%, which is critical for emergency patients in cardiogenic shock.

In the company's announcement, William O’Neill, MD, commented, “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. Additionally, access to data and real-time pump position improves efficiency for nurses and physicians in the intensive care unit and coronary care unit.” Dr. O’Neill is Medical Director, Center for Structural Heart Disease at Henry Ford Hospital in Detroit, Michigan.

Along with the Impella CP with SmartAssist, Abiomed's Impella 2.5, Impella CP, Impella 5.0, and Impella LD systems are FDA-approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and enable native heart recovery, allowing patients to return home with their own heart. The Impella 2.5, Impella CP, and Impella CP with SmartAssist are also approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions.

Additionally, Abiomed's right-side heart pump, the Impella RP device, is FDA-approved to treat patients experiencing acute right heart failure or decompensation after left ventricular assist device implantation, myocardial infarction, heart transplant, or open heart surgery.