GORE® CARDIOFORM ASD Occluder
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
Refer to Instructions for Use for complete indication.
* Defined as a clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the six month evaluation among subjects with technical success.
† Successful deployment and retention (at conclusion of index procedure) of a GORE® CARDIOFORM ASD Occluder.
‡ In subjects without prior history of arrhythmia, any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting > 45 days), or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.).
§ Defined as post-procedure embolization, device removal or other device reintervention from completion of the implant procedure through six months (180 days) post-procedure.
- GORE® CARDIOFORM ASD Occluder Imaging Training Tool. Flagstaff, AZ. W. L. Gore & Associates; 2017. [Digital training tool]. AW0214-EN1.
- GORE® CARDIOFORM ASD Occluder [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2019.