Device specifications

With the conformable design of the GORE® CARDIOFORM ASD Occluder, five catalogue numbers cover ASDs from 8 to 35 mm.*

Fives sizes of GORE CARDIOFORM ASD Occluder
Device size (Disc diameter)Treatment range measured with stop flow balloon sizingSheath size†U.S. catalogue number‡
27 mm8-15 mm10 FrASD27A
32 mm13-20 mm10 FrASD32A
37 mm18-25 mm11 FrASD37A
44 mm23-30 mm12 FrASD44A
48 mm28-35 mm14 FrASD48A

* 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. Rx only 

† Recommendation for sheath size is 2 Fr larger when used with a wire. 

‡ Catalogue numbers may vary by country or region.

 

eIFU Symbol

INDICATIONS FOR USE IN THE U.S.: The GORE® CARDIOFORM ASD Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs). 

CONTRAINDICATIONS: The GORE® CARDIOFORM ASD Occluder is contraindicated for use in patients: Unable to take anti-platelet or anticoagulant medications such as aspirin, heparin or warfarin; with anatomy where the GORE® CARDIOFORM ASD Occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins; with active endocarditis, or other infections producing bacteremia, or patients with known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement; with known intracardiac thrombi. 

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. Rx only 

Products listed may not be available in all markets.

241367309-EN

Residents of some states have the right to opt-out of the “sharing” or “selling” of their personal information. Gore does not "sell" the personal information of website users. Gore may "share" the personal information of website users, as standard advertising practice meant to offer you a more personalized service.

If you want to opt-out from Gore “sharing” your personal information, click on Opt-Out of Sharing to turn off the targeting cookies that we share with our advertising partners in order to provide you with personalized information. Disabling sharing will stop the use of cookies to targeted advertising but you may still see generic Gore ads.

Please note that your exercising of the rights outlined will have no adverse effect on the price and quality of our goods or services.

Opt-Out of Sharing

You Have Successfully Opted Out of the Sharing of Your Personal Information

Please note that if you clear your cookies and then use another device or browser, etc. your opt-out status is not transferred to the new device or browser.