An aVAD intraventricular heart pump from ReliantHeart, based out of Houston, Texas, has won approval in the European union, allowing the company to begin implants in the coming months.
The device, while only 2.5 centimeters in diameter, still has a 1.2 centimeters main channel for the blood to flow through. It rests outside the ventricle, while a component that is inserted into the heart contains an adjustable pump depth mechanism to provide optimal action for individual patients.
The company substantially reduced the power consumption of the pump, down to as little as 30 percent of the usage by other ventricular assist devices.
The pump is modeled on the already approved HeartAssist 5 device, having exactly the same blood path, but offering more power. This led to a quick approval by the European authorities.
The pump is already being manufactured with initial implantations to begin as early as September in Germany, Turkey, and U.K. Up to 50 patients will be implanted, with data collected at several time points after the procedure, including one, seven, 30, 90, and 160 days, or at the time of any adverse event.
An FDA animal trial is scheduled to begin this month and ReliantHeart is still anticipating a human FDA IDE trial to begin in early 2017.
