Category: Industry News

The FDA has recently approved the HeartWare™ HVAD™ System to be marketed

October 23, 2017

“The HeartWare™ HVAD™ System is a pump that helps the heart’s left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. It is used in some patients who have endstage heart failure, both those who are waiting for a heart transplant and those who are not eligible to receive a heart transplant. The system consists of a blood pump that is implanted inside the patient’s body and a pump controller that remains outside the patient’s body.”

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The FDA has recently approved the HeartMate 3™ Left Ventricular Assist System – P160054 to be marketed

October 23, 2017

“The HeartMate 3 Left Ventricular Assist System (LVAS) is a heart pump system that helps the heart’s left ventricle (the main pumping chamber of the heart) deliver blood to all parts of the body. The device is used for heart failure patients whose hearts are unable to pump blood effectively. The HeartMate 3 LVAS is made up of a blood pump that is implanted inside the patient’s body and a pump controller with batteries that remains outside the patient’s body.”

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The FDA has recently approved the Impella RP® System – P170011 to be marketed

October 19, 2017

“The FDA has recently approved the Impella RP® System. The Impella RP System is a temporary right heart pump system intended to help patients maintain stable heart function without open chest surgery. It includes a mini heart pump mounted at the end of a thin, flexible tube (catheter), a console that drives the pump, and an infusion system that flushes the pump.”

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Cardiology Societies to Expand Maintenance of Certification Offerings

October 17, 2017

“The American College of Cardiology (ACC), Heart Failure Society of America (HFSA), Heart Rhythm Society (HRS) and Society for Cardiovascular Angiography and Interventions (SCAI) have announced a partnership to develop new modules to help subspecialty cardiologists potentially meet collaborative maintenance pathway requirements equivalent to satisfying the ABIM’s current 10-year MOC examination.”

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