Blog Tag: Ireland
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.
OrbusNeich Medical Inc. and its subsidiary, Orbus International B.V., announced on Friday a lawsuit against Boston Scientific Corp. in Ireland for alleged patent infringement. According to the press release, the lawsuit alleges that Boston Scientific’s coronary stent systems, including the PROMUS Element™, PROMUS Element Plus™, OMEGA™, TAXUS™, SYNERGY™, and Promus PREMIER™ lines of stents, infringe European Patent No. 2,311,412 and European Patent No. 1,341,482, both entitled “Stent having helical elements,” granted on August 9, 2012 and September 23, 2010, respectively. Figure 11 from the ‘412 patent is shown below:
In February, OrbusNeich filed suit against Boston Scientific for patent infringement in Germany and the Netherlands. A patent infringement suit filed by OrbusNeich against Boston Scientific in the U.S. in 2009 was stayed pending reexamination of the patents by the U.S. Patent and Trademark Office. The asserted European patents are available at EP 2,311,412 and EP 1,341,482.