GORE® CARDIOFORM ASD Occluder

Advanced materials delivering exceptional conformability^†,§,II,1

Developed by a company with 60 years of materials science experience
Engineered to conform to a broad range of ASD anatomies^§,1,2
No minimum retro-aortic rim requirements²

GORE CARDIOFORM ASD Occluder with callouts of material magnified 250 times and device 30 days post-implant in canine model.

Angled and side views of GORE CARDIOFORM ASD Occluder.

See deficient rim ASD closure cases

Trusted deployment^{††, 2}

Straightforward delivery with the ability to retrieve and reposition^{††, 2}
Pre-assembled occluder and delivery system² designed to reduce device preparation time

Hand holding a GORE CARDIOFORM ASD Occluder with product features called out. — The built-in retrieval cord allows for tension-free assessment and post-lock retrieval, if needed.²

Watch how GORE® CARDIOFORM ASD Occluder is deployed

1-2-3 Deployment sequence^††

1. Deploy

Handle design with slider enables accurate deployment with the ability to reposition.

GORE CARDIOFORM ASD Occluder delivery handle in lock mode next to a fluoroscopic image of the ASD occluder.

2. Lock

Simple-to-use locking mechanism. Tension-free assessment post-lock where the occluder remains tethered to the delivery system.

GORE CARDIOFORM ASD Occluder delivery handle in lock mode next to a fluoroscopic image of the ASD occluder.

3. Release

Pull the retrieval cord until completely removed to release the device from the delivery system.

GORE CARDIOFORM ASD Occluder handle in release mode next to a fluoroscopic image of the ASD occluder.

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* Deficient retro-aortic rim was defined as a retro-aortic rim measuring less than or equal to 5 mm on any view on echocardiogram.

† Closure success defined as completely occluded or clinically insignificant shunt as determined by the Echo Core Lab at the 6-month evaluation among subjects with technical success.²

‡ Reported incidence rate of device-related cardiac erosions for GORE® CARDIOFORM ASD Occluder calculated using data from CATSWeb® Product Surveillance Tracking System [PSTS] and SmartSolve®. Data on file. March 1, 2015 – July 31, 2024; W. L. Gore & Associates Inc.; Flagstaff, AZ.

§ All ASD anatomies within indicated sizing parameters of the Instructions for Use.

II 100% closure success rate across ASD anatomies at 6 months.^†,§,1

¶ Nickel titanium.

** Patients allergic to nickel may suffer an allergic reaction to the GORE® CARDIOFORM ASD Occluder. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty in breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.

†† Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. R_XOnly

‡‡ Data on file. W. L. Gore & Associates, Inc.; Flagstaff, AZ.

Sommer RJ, Love BA, Paolillo JA, et al.; ASSURED Investigators. ASSURED clinical study: new GORE® CARDIOFORM ASD Occluder for transcatheter closure of atrial septal defect. Catheterization & Cardiovascular Interventions 2020;95(7):1285-1295.
GORE® CARDIOFORM ASD Occluder [Instructions for Use]. Flagstaff, AZ.: W. L. Gore & Associates, Inc; 2024. MD200690.

Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. R_XOnly

CATSWeb is a trademark of AssurX, Inc. SMARTSOLVE is a trademark of Ethos Technologies Inc.

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