First HeartAssist5® VAD Implant Performed in the U.S.

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A patient at the University of Chicago was the first in the United States to be implanted with the HeartAssist5® Ventricular Assist Device (VAD) as part of an FDA clinical trial being conducted by Houston-based ReliantHeart, Inc.

Some novel features in this device have the potential to improve patient outcomes. The pumping mechanism is designed to reduce the risk of blood clots and the built-in wireless monitors can alert the team early if blood flow issues develop.

A patient at the University of Chicago Medicine was the first in the United States to be implanted with the HeartAssist5® Ventricular Assist Device (VAD) as part of an FDA clinical trial being conducted by Houston-based ReliantHeart, Inc.

The HeartAssist5® VAD is a small mechanical pump implanted to support left heart function when the left ventricle can no longer pump enough blood to sustain the body. The FDA Investigational Device Exemption (IDE) clinical trial in the U.S. will evaluate the safety and efficacy of 96 patients implanted with ReliantHeart’s HeartAssist5® VAD compared to 96 patients implanted with either a Thoratec HeartMate II® LVAD or HeartWare HVAD®, in providing left ventricular support while awaiting cardiac transplantation. The trial is expected to run through 2016.

“Some novel features in this device have the potential to improve patient outcomes,” said Valluvan Jeevanandam, MD, professor of surgery and section chief of cardiac surgery at the University of Chicago. “The pumping mechanism is designed to reduce the risk of blood clots and the built-in wireless monitors can alert the team early if blood flow issues develop.”

The HeartAssist5® VAD provides benefits not currently available with existing VAD technology such as a proprietary true-flow measurement system and the HeartAssistRemote™ Monitoring System, which continuously transmits patient data to expert clinicians 24 hours per day via vadlink.com. These optimized device features may allow for faster and more precise diagnosis of potential issues.

The HeartAssist5® is approved in Europe for patients awaiting a heart transplant and as a destination therapy for patients who are not candidates for cardiac transplantation.

About ReliantHeart Inc.
ReliantHeart Inc. is a leading innovator in mechanical circulatory support therapies for advanced stage heart failure. The company manufactures the HeartAssist5®, a next generation ventricular assist device (VAD) which has CE Mark approval for commercial sale in Europe. The HeartAssist5® is an implantable, electric pump designed for use in patients requiring ventricular support due to end stage heart failure and is the world’s only remotely monitored VAD. ReliantHeart is privately held and headquartered in Houston, Texas. For more information please visit http://www.reliantheart.com

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