ReliantHeart has announced that its HeartAssist5 ventricular assist device, which includes True Flow remote monitoring, has received CE Mark approval in Europe.
HeartAssist5 is an implantable, electric pump designed for use in patients requiring ventricular support due to end-stage heart failure.
The CE Mark approval that includes remote monitoring via vadlink.com provides remote and True Flow measurement of the ventricular assist device.
ReliantHeart claims that the VadLink network is the world's only remote monitoring service, connecting clinicians that monitor the HeartAssist5 to patients supported by the device. The VadLink website offers notifications that are customisable.
ReliantHeart has further customised this network for each implanting centre so that the real-time data is available for monitoring by the implanting centre clinicians.
The next-generation ventricular assist device provides accurate measurement of True Flow, which is now available over vadlink.com.
ReliantHeart claims that HeartAssist5 is the only device with direct flow measurement that precisely monitors blood flow and related data.
This information is useful when a patient is stable, but can prove vital if a patient is experiencing complications.
The HeartAssist5 Flow Probe is the an effective method of observing interaction between the HeartAssist5 and the ventricle.
In addition to flow data, the HeartAssist5 tracks speed and electrical current usage by the pump motor, providing information both about the volume of blood flow and its fluidity.
ReliantHeart claims that HeartAssist5 is the smallest of all Full Flow ventricular assist devices.
Image: Placement of the HeartAssist5 ventricular assist device with remote and true flow measurement monitoring. Photo: courtesy of MarketWired.