Houston, Texas. November 10, 2013 – The ReliantHeart HeartAssist5® Ventricular Assist Device (VAD) has been CE Mark* approved in Europe for use in patients requiring ventricular support due to end stage heart failure. The HeartAssist5® is approved for bridge to transplant (BTT) patients awaiting cardiac transplantation and for destination therapy (DT) patients who are not candidates for cardiac transplantation.
An earlier CE mark was granted October of 2012 to allow around the clock remote monitoring with the HeartAssist5® Conquest Controller™, a lightweight wearable controller designed to collect critical flow data. That data, as well as speed and power measurements, are transmitted to caregivers through the exclusive HeartAssist5® Remote Monitoring System. The HeartAssist5® is the only remotely monitored VAD in the world.
ReliantHeart competes in Europe with two companies: Thoratec (THOR) and HeartWare (HTWR). On November 6, 2013, HeartWare announced strong third quarter results of a 140% increase over same period last year. Revenue from international markets, generated through the sale of 287 units, was $26.6 million, an increase of approximately 38% from $19.3 million in the third quarter of 2012.
ReliantHeart intends to enter the U.S. market through an IDE, which will allow the HeartAssist5® to be sold for use in a clinical trial approved by the FDA to collect safety and effectiveness data.
*The European Union applies the CE (Conformité Européenne) Marking process to ensure patient/user safety and to enforce that the manufacturer’s device fulfills what it is designed to perform.