This document aims to define the requirements for a leadless and completely autonomous cardiac therapy system. In this document we focus on the physical, electrical and reliability requirements. And they will be segmented according to two levels. The first one will be a baseline of the state of the art of existing devices and the second describes our expectations for the MANpower device
There are few components more “mission critical” than an implanted cardiac device: it must deliver 10+ years with 100% reliability - devices are life-sustaining: a single failure is critical. A target such as this can only be met by making analysis and optimisation of reliability, durability and biocompatibility a priority from the most basic stages of research. Further, the approach to doing this must be consistent at all scales from nano to micro to macro for all materials, structures, systems integration and packaging based on a top-down “essential performance” methodology to international standards and best practice. This deliverable sets out the MANpower high level approach to meeting these objectives.