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FDA approves St Jude's Unify and Fortify cardiac devices

This article was originally published in Clinica

Executive Summary

The US FDA has granted premarket approval (PMA) for St Jude Medical's Unify cardiac resynchronisation therapy defibrillator (CRT-D) and Fortify implantable cardioverter defibrillator (ICD). Unify and Fortify are the smallest devices of their type available, but have similar longevity and power to competing products, St Jude claims. Their small size allows physicians to make a smaller incision when implanting them, reducing procedure times and scarring. The devices also feature "advanced sensing technology" to reduce the risk of inappropriate defibrillation therapy. The St Paul, Minnesota firm CE marked both devices for sale in Europe in February.

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