CardiacAssist gets US OK for TandemHeart PTVA (percutaneous transseptal ventricular assist) technology:
This article was originally published in Clinica
CardiacAssist can now market in the US its TandemHeart percutaneous transseptal ventricular assist (PTVA) system for short-term circulatory support, after gaining FDA 510(k) clearance for the product's final component: the transseptal cannula. The TandemHeart PTVA device was previously CE-marked for sale in Europe in 2000. It can be used to support critically ill patients with heart failure and cardiogenic shock. The system is currently being compared with conventional intra aortic balloon pump therapy in a cardiogenic shock trial in the US, says the Pittsburgh, Pennsylvania firm.
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