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.
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CONTACT: ReliantHeart, Inc.
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