Related Manuals for GORE CARDIOFORM
Summary of Contents for GORE CARDIOFORM
- Page 1 INSTRUCTIONS FOR USE FOR: English Magyar Български Italiano Čeština Lietuvių Dansk Norsk Nederlands Polski Eesti Português Suomi Română Français Slovenčina Deutsch Español Ελληνικά Svenska...
-
Page 3: Indications / Intended Use
The GORE® CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs). CONTRAINDICATIONS The GORE® CARDIOFORM Septal Occluder is contraindicated for use in patients: • Unable to take anti-platelet or anticoagulant medications such as aspirin, heparin, or warfarin. - Page 4 WARNINGS • The GORE® CARDIOFORM Septal Occluder is not recommended for, and has not been studied in, patients with other anatomical types of ASDs that are eccentrically located on the septum (e.g. sinus venosus ASD and ostium primum ASD), or fenestrated Fontan.
-
Page 5: Clinical Studies
Adverse Events Clinical Summary The GORE® CARDIOFORM Septal Occluder was evaluated in a multi-center, non-randomized, Pivotal Study that included 50 subjects. An Independent Data Reviewer provided external oversight and review of subject safety data, including evaluation of all reported adverse events for accuracy of event coding, seriousness, and relationship to the device. - Page 6 The measurement of the balloon’s waist (i.e. the narrowest portion) was recorded as the defect diameter and used to determine the appropriate size GORE® CARDIOFORM Septal Occluder. Fluoroscopic and echocardiographic guidance were used throughout the procedure for placement and assessment of the GORE®...
- Page 7 Primary, safety, and efficacy endpoint results are shown in Table 4. All subjects with an atrial septal aneurysm, multiple fenestrations or deficient retroaortic rim who received a GORE® CARDIOFORM Septal Occluder had complete clinical closure and no Serious Adverse Events at 6 months.
-
Page 8: How Supplied
Technical Success with completely occluded defect or clinically insignificant residual shunt at 6 months HOW SUPPLIED The GORE® CARDIOFORM Septal Occluder is supplied sterile in a protective tray and pouch. Provided that the integrity of the pouch is not compromised in any way, it will serve as an effective barrier until the “use by”... - Page 9 Attach the syringe to a stopcock and the Flush Port. Flush the device until air no longer exits the tip of the Delivery Catheter. When the initial flushing is completed, begin loading the Occluder by pushing the Slider up and then to the right until the Slider stops (Figure 4a).
- Page 10 Gently pull on the Handle to bring the left atrial disc onto the surface of the left atrial septum. Deploy the right atrial disc by pushing the Slider to the left until it stops and then down. Confirm that the Slider has moved completely to the left and down position (Figure 6c).
- Page 11 If the patient’s septal anatomy is determined to be unsuitable for the GORE® CARDIOFORM Septal Occluder, alternative treatment options such as other devices or surgical closure of the defect should be considered.
- Page 12 Artifact Information MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the GORE® CARDIOFORM Septal Occluder. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
- Page 13 DEFINITIONS Use By Caution Consult Instructions for Use Do Not Resterilize STERILIZE Do Not Reuse Catalogue Number Batch Code Serial Number MR Conditional CAUTION: USA Federal Law restricts the sale, distribution, or use of this device to, by, or on the order of a physician. Sterile Sterilized using Ethylene Oxide Do Not Use if Package is Damaged...
- Page 16 Technical Information: Tel.: 928.779.2771 • Tel.: 800.437.8181 For international contact and additional product information, www.goremedical.com visit GORE®, CARDIOFORM and designs are trademarks of W. L. Gore & Associates. © 2012, 2014-2015 W. L. Gore & Associates, Inc. APRIL 2015 Printed on recyclable paper...
Need help?
Do you have a question about the CARDIOFORM and is the answer not in the manual?
Questions and answers