Physician-to-Physician Presentation - Gore Medical
Physician-to-Physician Presentation - Gore Medical Physician-to-Physician Presentation - Gore Medical
GORE HELEX Septal Occluder SizingThe GORE HELEX Septal Occludercomes in five sizes(15 mm – 35 mm)It is recommended for ASDsand PFOs measuring up to 18 mmWhen choosing the appropriatesize, a 2:1 device diameter todefect diameter ratiois recommended
INDICATIONS FOR USE OUTSIDE THE US: The GORE HELEX Septal Occluder is a permanentlyimplanted prosthesis indicated for the percutaneous, transcatheter closure of atrial septal defects(ASDs), such as ostium secundum and Patent Foramen Ovale. Refer to Instructions for Use atgoremedical.com for a complete description of all contraindications, warnings, precautions andadverse events.Products listed may not be available in all markets.GORE, HELEX, and designs are trademarks of W. L. Gore & Associates.© 2009 W. L. Gore & Associates, Inc. AL0049-EU1 JUNE 2009
- Page 2 and 3: IndicationThe GORE HELEX Septal Occ
- Page 4: Device ComponentsePTFECentral Eyele
- Page 8 and 9: Flat Profile and Low Metal Mass
- Page 10 and 11: Inert and BiocompatibleePTFE proven
- Page 12 and 13: Hydrophilic CoatingHydrophilic coat
- Page 14 and 15: US Clinical Trial Data SummaryFeasi
INDICATIONS FOR USE OUTSIDE THE US: The GORE HELEX Septal Occluder is a permanentlyimplanted prosthesis indicated for the percutaneous, transcatheter closure of atrial septal defects(ASDs), such as ostium secundum and Patent Foramen Ovale. Refer <strong>to</strong> Instructions for Use atgoremedical.com for a complete description of all contraindications, warnings, precautions andadverse events.Products listed may not be available in all markets.GORE, HELEX, and designs are trademarks of W. L. <strong>Gore</strong> & Associates.© 2009 W. L. <strong>Gore</strong> & Associates, Inc. AL0049-EU1 JUNE 2009
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