Catalog excerpts
Clear data. Confident stroke prevention. GORE® CARDIOFORM Septal Occluder FDA approved for PFO* closure — The advanced stroke prevention solution for cryptogenic stroke patients.
Open the catalog to page 1GORE® CARDIOFORM Septal Occluder An advanced occluder designed in partnership with global leading interventional cardiologists. The GORE® CARDIOFORM Septal Occluder is approved for atrial septal defects (ASD) and now FDA approved for patent foramen ovale (PFO) closure to reduce the risk of recurrent ischemic stroke in select patients.*
Open the catalog to page 2Groundbreaking stroke reduction • 77% relative reduction in stroke with PFO closure plus medical therapy versus medical therapy alone**4 Continued legacy of safety • No significant difference in overall serious adverse events (SAE) rate between closure and medical therapy groupst4 • Low device and procedure-related SAEs*4 High procedural success • 98.8% successful implant and retention of device § • 98% effective closure at 12 months 11,1 • Simplified delivery
Open the catalog to page 3Groundbreaking stroke reduction As published in the New England Journal of Medicine The Gore REDUCE Clinical Study is the only U.S. IDE trial that achieved its primary end point and showed the largest reduction in recurrent ischemic stroke**,1 in all PFO shunt sizes over medical therapy alone. Relative Stroke Reduction **,1 Freedom from recurrent stroke Hazard ratio = 0.23 One-sided p-value = 0.001 Follow-up time (months) Four times the protection Protects against Number needed to treat: Only against recurrent stroke than potentially disabling 28 patients treated to prevent
Open the catalog to page 4No significant difference in overall SAE rate between closure and medical management group.**4,1 Any serious adverse event Closure (N = 441) Medical (N = 223) P-value''' No significant difference in risk of serious atrial fibrillation, bleeding, deep vein thrombosis, or pulmonary embolism with PFO closure.**4 Serious adverse events of interest Serious atrial fibrillation / Atrial flutter Bleeding Deep vein thrombosis Pulmonary embolism Low device and procedure-related SAEs*4 Related to device Related to the procedure Related to device Related to the procedure
Open the catalog to page 5High global procedural success Clinicians in seven countries experienced high technical success and high effective closure rates. technical success effective closure rate at 12 months Preassembled with minimal prep steps for simplified delivery.*
Open the catalog to page 6Catalogue number Contact your Gore technical sales associate for more information.
Open the catalog to page 7* Refer to Instructions For Use for complete indication. ** The REDUCE study determined safety and efficacy of patent foramen ovale (PFO) closure with the GORE® CARDIOFORM Septal Occluder or GORE® HELEX® Septal Occluder plus antiplatelet medical management compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke. All PFO anatomies were incorporated into this study within indicated sizing parameters of the Instructions for Use. † There was no statistically significant difference in the rate of serious adverse events (SAE) between the closure...
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