CE certification allows for free movement of the Hourglass™ device within the EU and indicates that the Hourglass™ device meets EU safety, health, and environmental requirements and complies with EU legislation. According to EU guidelines, Class IIb includes “[a]ll non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids, or other liquids intended for infusion into the body . . . .”
The press release suggests that the Hourglass™ device is the first device of its kind – George Wallace, CEO of EMBA Medical Limited, stated:
This is the first integrated, over-the-wire device designed for peripheral embolization procedures . . . . The goal with over-the-wire design is to provide physicians with accurate, stent-like delivery of the device in the vessel. We believe that the Hourglass™ implant will provide a level of confidence, precision, and control for peripheral embolization procedures that physicians have come to enjoy over the years while performing other types of over-the-wire endovascular procedures.
In addition, EMBA Medical recently received ISO certification for its facility in Miramar, Florida, where the Hourglass™ devices will be manufactured. Specifically, EMBA Medical received certification for ISO 13485:2003 for quality management systems specific to organizations providing medical devices.
The Hourglass ™ device is not presently approved for sale in the United States.