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Heart Pump With Optical Sensor Garners Approval
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Abiomed announced that its new heart pump with an optical sensor has received premarket approval from the FDA for treatment of patients with cardiogenic shock.
According to a press release from the company, the heart pump (Impella CP with SmartAssist) is designed to reduce procedure time by using advanced software and optical sensors to improve positioning for the pump and allowing for repositioning without the need for imaging equipment.
The system also integrates clinical data informatics on a console to provide real-time information displays of left ventricular pressure, end-diastolic pressure and cardiac power output, according to the release.
The new heart pump also enables a faster set-up with fewer steps and connections, resulting in a start time reduced by 15%, the company stated in the 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,” William W. O’Neill, MD, FACC, FSCAI, medical director of the Center for Structural Heart Disease at Henry Ford Hospital and a member of the Cardiology Today’s Intervention Editorial Board, said in the release. “Additionally, access to data and real-time pump position improves efficiency for nurses and physicians in the ICU and CCU.”
Disclosures: O’Neill reports he receives consultant fees/honoraria from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic and holds equity in Neovasc.