ReliantHeart HeartAssist5(R) VAD achieves CE Mark for European distribution HOUSTON, Texas, Nov. 10, 2013 (GLOBE NEWSWIRE) -- via PRWEB - The ReliantHeart HeartAssist 5®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 HeartAssist 5® is approved for bridge to transplant (BTT) patients awaiting cardiac transplantation and for destination therapy (DT) patients who are not candidates for cardiac transplantation. The CE Mark for the HeartAssist 5® was previously granted to MicroMed Technology, Inc. and was first available for European distribution in 2009. Through completion of a court approved transaction, ReliantHeart, Inc. has become the successor-in-interest to the assets of MicroMed Technology, Inc., and will manufacture, sell and support the HeartAssist5® and its suite of VAD products and accessories. An amendment to the 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 (Investigational Device Exemption), 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. This article was originally distributed on PRWeb. For the original version including any supplementary images or video, visit http://www.prweb.com/releases/2013/11/prweb11315432.htm CONTACT: ReliantHeart, Inc. Sailesh Saxena email@example.com 713-457-1480
ReliantHeart HeartAssist5(R) VAD achieves CE Mark for European distribution
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