Atrial septal closure occlusion device GORE® CARDIOFORM

atrial septal closure occlusion device
atrial septal closure occlusion device
atrial septal closure occlusion device
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Characteristics

Applications
atrial septal closure

Description

The GORE® CARDIOFORM ASD Occluder's anatomically adaptable waist fills and conforms to each unique defect to close a broader range of ASDs.1 Confident closure that is clinically proven for a wider range of ASDs The latest addition to the GORE® CARDIOFORM Occluder family extends what physicians can achieve in the minimally invasive treatment of heart defects. It offers closure with a soft, conformable device not previously available for larger ASDs, which typically have a greater risk for complications like pulmonary hypertension, right heart enlargement, or atrial fibrillation. The ability to retrieve and reposition the device helps ensure proper positioning. The GORE® CARDIOFORM ASD Occluder consists of a proprietary, thromboresistant ePTFE material over a nitinol wire frame, designed to minimize wall injury and allow tissue ingrowth for short- and long-term performance. It is the latest addition to the GORE® CARDIOFORM Occluder Family, which also includes the GORE® CARDIOFORM Septal Occluder, indicated for ASD closure for defects up to 17 mm and patent foramen ovale (PFO) closure to prevent recurrent ischemic stroke. Designed in partnership with leading interventional cardiologists across the globe, the GORE® CARDIOFORM ASD Occluder builds on a legacy of safety. Gore ASSURED Clinical Study Confident closure. 100% closure success rate at six months.*,2 96% rate of technical success.†,2 No retro-aortic rim required – effective closure with retro-aortic rim lengths of 0 - 27 mm (median of 4 mm).2 Low rate of 30-day SAEs: 4.8%.2 Low rate of clinically significant new arrhythmia: 4.8%.‡,2 Low rate of device events at six months (2.4%).§,2

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.