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Article: Arrow receives CE-mark certification in Europe to market LionHeart LVAS.(Brief Article)
- Article from:
- Transplant News
- Article date:
- November 15, 2003
CopyrightCOPYRIGHT 2003 Transplant Communications, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Arrow International, Inc., Reading, PA, announced it has received authorization from its European Notified Body, TUV Product Services of Munich, Germany, to CE-mark the Arrow LionHeart, the company's left ventricular assist device. The CE mark provides authorization to market the device within the European Economic area for permanent implantation, or "destination therapy."
The Arrow LionHeart is a fully implantable device designed for long-term implantation and is the first LVAS to receive CE-marking authorization specifically for the destination therapy indication. Arrow says the authorization will allow it to begin the commercial development of the destination ...