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New Products In Brief

This article was originally published in The Gray Sheet

Executive Summary

Right side of heart pump: FDA grants Humanitarian Device Exemption on Oct. 7 to Levitronix' CentriMag right ventricular assist system for temporary support of critically ill patients with a failing right ventricle. Safety data from two multi-center clinical trials showed that the benefits of CentriMag outweigh its risks, FDA says. The device is designed to support patients up to 14 days or until a heart transplant or long-term heart assist device can be implanted. "While severe right-side heart failure is uncommon, it can lead to death," states FDA. "It is often caused by left-side heart failure or, in unusual cases, by heart surgery.

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