Gore announces availability of septal occluder:
This article was originally published in Clinica
Executive Summary
W L Gore & Associates forecasts that its HELEX septal occluder device, recently launched in Europe, Australia and South America, could gain US marketing approval in around three years. The device, which is being studied under an investigational device exemption, has "significant advantages over [current]-devices", claims the Flagstaff, Arizona firm. When fully deployed, it takes on a double disc, rounded shape that minimises the risk of trauma to cardiac structures. It also incorporates a retrieval cord system that allows the device to be removed, even after it has been released from the catheter delivery system.