http://blog.medicalproductguide.com A comprehensive guide to medical products for medical professionals Mon, 20 Jun 2011 12:36:09 +0000 en hourly 1 http://wordpress.org/?v=3.1.3 http://blog.medicalproductguide.com/2008/10/14/fda-approves-hde-for-levitronixs-heart-pump/ http://blog.medicalproductguide.com/2008/10/14/fda-approves-hde-for-levitronixs-heart-pump/#comments Tue, 14 Oct 2008 07:28:57 +0000 Jim Marino http://www.medicalproductguide.com/blog/2008/10/14/fda-approves-hde-for-levitronixs-heart-pump/ The U.S. Food and Drug Administration has given the approval in the form of a Humanitarian Device Exemption (HDE) for Levitronix’s CentriMag Right Ventricular Assist System providing patients in critical condition with temporary aid for the right ventricle of their heart. The heart pump supports the pumping action of a heart not functioning properly. The indication facilitates the development of the device for treatment of the severe right-side heart failure, which although uncommon, can lead to death. The device was found to be safe for use.

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