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Abiomed Earns FDA Approval for Adding Optical Sensor to Impella CP Heart Pump

The sensor is part of the SmartAssist technology, which enables real-time display of clinical data.

Abiomed, which had a busy 2017 and was among our Company of the Year finalists, reported today that it has received FDA premarket approval (PMA) for its Impella CP heart pump with SmartAssist, utilizing an optical sensor. The sensor is one component of the SmartAssist technology, which also includes a software update enabling informational displays of left ventricular pressure (LVP), end-diastolic pressure (EDP), and cardiac power output (CPO) data on the Impella Console, an Abiomed spokesperson told MD+DI.

The Impella CP heart pump had already earned FDA approval for treating patients in cardiogenic shock as well as patients undergoing high-risk percutaneous coronary intervention (PCI). The addition of the SmartAssist and optical sensor technology “improves understanding of real-time, exact positioning for the Impella heart pump and allows for repositioning without the need for imaging equipment,” the company reported in a news release. Real-time display of LVP, EDP, and CPO data is also expected to help practitioners. The additions are expected to lead to faster set-up with fewer steps and connections for physicians, cath lab staff, and ICU staff.

“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, Medical Director, Center for Structural Heart Disease, Henry Ford Hospital, in the release. “Additionally, access to data and real-time pump position improves efficiency for nurses and physicians in the ICU and CCU.”

Abiomed had already achieved CE marking approval in the European Union to market Impella CP with SmartAssist, with more than 60 patients treated at three sites with Impella CP with optical sensor. In addition, 38 patients at two U.S. hospitals have been treated using the Abiomed Impella Controller with clinical data informatics.

Abiomed will launch the Impella CP with SmartAssist over the next fiscal year through a controlled roll-out at hospital sites with established heart recovery protocols, the company stated. Upgrades to Abiomed’s existing installed base will be performed during routine service cycles.

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  • United States
  • Abiomed

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