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General| FDA Approval | Yes |
|---|---|
| CE Mark | Yes |
| Device Type | Occluder |
| Product Type | Septal Occluder |
| Material | ePTFE and Nitinol |
| Delivery System Compatibility | Compatible with GORE Delivery System |
| Delivery System | GORE CARDIOFORM Delivery System |
| Indication | Atrial Septal Defect (ASD) closure |
| Occluder Sizes | 20 mm, 25 mm, 30 mm |
| Sizes Available | 20 mm, 25 mm, 30 mm |
Details the GORE® CARDIOFORM Septal Occluder, its components, and the delivery system.
Specifies the device is for percutaneous, transcatheter closure of ostium secundum atrial septal defects.
Lists patient conditions or anatomical issues where the device should not be used.
Highlights warnings regarding device suitability, sizing, and potential patient reactions.
Covers device handling, single-use policy, inspection, and expiration date adherence.
Outlines requirements for using the device, including sheath size, ACT, and imaging.
Details post-implantation patient management, including therapy, activity, and follow-up.
Summarizes clinical trial data on device-related adverse events, including types and frequencies.
Describes the pivotal study, patient selection criteria, and study methodology.
Details study procedures, follow-up evaluations, and definitions of primary/secondary endpoints.
Presents the results of the pivotal study concerning procedural success and clinical outcomes.
Information on how the device is packaged, supplied sterile, and its shelf life.
Lists essential accessories needed for the device procedure.
Lists optional accessories that may be used during the procedure.
Guides on measuring the defect and selecting the appropriate occluder size.
Instructions for preparing the venous access site before sheath insertion.
Details on preparing and loading the occluder onto the delivery system.
Steps for delivering the occluder catheter and associated components.
Instructions for deploying the left and right atrial discs of the occluder.
Procedure for locking the occluder and safely removing the delivery system.
Instructions for reloading the occluder before locking if repositioning is needed.
Steps for removing the locked occluder using the retrieval cord.
Methods for recapturing a malpositioned or otherwise problematic occluder.
Provides critical information on the device's MR conditional status and scanning parameters.
Details conditions for safe scanning, including magnetic field, gradient, and SAR limits.
Describes potential impact on MR image quality due to the device's presence.
Explains the meaning of various symbols and terms used throughout the manual.
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