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<strong>Device</strong> <strong>Overview</strong><br />
PER F ORM ANC E b y d e s i g n
Indication<br />
The GORE ® HELEX ® Septal Occluder is a permanently implanted prosthesis indicated for the<br />
percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs). Refer to<br />
Instructions for Use at goremedical.com for a complete description of all contraindications,<br />
warnings, precautions and adverse events.
Product Attributes<br />
• Conformable Discs<br />
• Flat Profile<br />
• ePTFE Occlusion Membrane<br />
• Single-Wire Nitinol Frame
<strong>Device</strong> Components<br />
ePTFE<br />
Central Eyelet<br />
Nitinol Frame<br />
Right Atrial Eyelet<br />
Delivery Catheter
<strong>Device</strong> Components<br />
Locking Loop<br />
Right Atrial Eyelet<br />
Retrieval Cord<br />
Control Catheter
Delivery System<br />
Delivery Catheter<br />
Control Catheter<br />
Retrieval Cord<br />
Retrieval Cord Cap<br />
Mandrel Luer
Locking the <strong>Device</strong><br />
Pre-Lock<br />
Post-Lock<br />
Extended Lock Loop<br />
(in Tan Mandrel)<br />
Right<br />
Atrial<br />
Eyelet<br />
Green<br />
Delivery Catheter<br />
Retrieval Cord<br />
Left Atrial Eyelet<br />
Mandrel Flare<br />
Retrieval Cord<br />
Tan<br />
Green<br />
Mandrel<br />
Delivery Catheter<br />
Left Atrial Eyelet<br />
Steel Mandrel<br />
Stiffener (Red<br />
in Illustration)<br />
Tan<br />
Mandrel<br />
Radiopaque Tip<br />
Right Atrial<br />
Eyelet<br />
Gray<br />
Control Catheter<br />
Center<br />
Eyelet<br />
Radiopaque Tip<br />
Lock Loop<br />
Gray<br />
Control Catheter<br />
Center<br />
Eyelet<br />
Mandrel is pulled back<br />
Lock loop forms
Flat Profile and Low Metal Mass
Conformable Discs<br />
Fluoroscopy at one month follow-up<br />
in patient with deficient anterior<br />
superior rim<br />
<strong>Device</strong> observed splaying aorta
Inert and Biocompatible<br />
ePTFE proven in more than<br />
30 million clinical implants<br />
Reduced thrombogenicity<br />
Porosity engineered for controlled<br />
tissue response<br />
Allows formation of functional<br />
intimal lining<br />
After three months in canine model
Easily Retrievable<br />
Retrieval cord maintains tether<br />
between device and delivery system<br />
Allows tension-free confirmation<br />
of device position after lock release,<br />
and easy retrieval if necessary
Hydrophilic Coating<br />
Hydrophilic coating facilitates<br />
immediate wetting of membrane<br />
Dry<br />
Wet<br />
Clear echo visibility of the device
Animal Data<br />
In vivo tissue response demonstrating flat profile, conformance<br />
to the septum, and thromboresistant Occluder material.<br />
Left Atrial View<br />
Right Atrial Side View<br />
Retrieval after three months<br />
in canine model
US Clinical Trial Data Summary<br />
Feasibility Pivotal * Continued Access<br />
Subjects Enrolled 63 143 189<br />
Median Age (years) 11 (0.5 - 65) 6.5 (1.4 - 72.4) 5.4 (0.8 - 58.4)<br />
Successful Implant<br />
86.4% of attempted<br />
implants (51 / 59)<br />
88.1% of attempted<br />
implants (119 / 135)<br />
85.6% of attempted<br />
implants (137 / 160)<br />
Adverse Events 3.9% 5.9% 2.2%<br />
Clinically Successful<br />
94.6% 98.1% 99.1%<br />
Occlusion<br />
Composite Clinical Success 89.5% 91.9% 96.7%<br />
*<br />
Two arm study comparing surgical closure to device closure<br />
Clinically Successful Occlusion: No residual leak or insignificant residual leak<br />
Composite Clinical Success: Clinically successful occlusion AND no major adverse event<br />
Three US clinical studies were conducted to evaluate the GORE ® HELEX ® Septal Occluder. These studies were<br />
performed with the original delivery system. The product described here is the same Occluder with a modified delivery<br />
system. Please note that the modified delivery system was not evaluated under the original US clinical study.
US Clinical Trial Key Points<br />
GORE ® HELEX ® Septal Occluder is safe and effective for the closure of ASDs<br />
No instances of perforation of cardiac structures<br />
No instances of thrombus on the device<br />
Optimal results when 2:1 nominal device diameter to defect diameter ratio is<br />
used to close defects up to 18 mm<br />
Clinical Trial Data<br />
<strong>Device</strong> to Defect Ratio<br />
< 1.6<br />
1.6 – 2.0 2.0 or greater<br />
Clinical Closure 92.6% 96.3% 100.0%<br />
Embolization Rate 3.0% 4.2% 0.0%<br />
Composite Success 80.0% 90.0% 95.0%<br />
*<br />
Information comes from Latson, et al., Analysis of factors related to successful transcatheter closure of secundum atrial septal defects using<br />
the HELEX ® septal occluder. American Heart Journal 2006;151:1129.e7-1129.e11.
GORE ® HELEX ® Septal Occluder Sizing<br />
The GORE ® HELEX ® Septal Occluder<br />
comes in five sizes<br />
(15 mm – 35 mm)<br />
It is recommended for ASDs<br />
measuring up to 18 mm<br />
When choosing the<br />
appropriatesize, a 2:1 nominal<br />
device diameter to defect diameter<br />
ratio is recommended
INDICATIONS FOR USE IN THE US: The GORE ® HELEX ® Septal Occluder is a permanently implanted prosthesis<br />
indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs). Refer<br />
to Instructions for Use at goremedical.com for a complete description of all contraindications, warnings,<br />
precautions and adverse events..<br />
Products listed may not be available in all markets.<br />
GORE ® , HELEX ® , PERFORMANCE BY DESIGN, and designs are trademarks of W. L. <strong>Gore</strong> & Associates.<br />
© 2009, 2010, 2012 W. L. <strong>Gore</strong> & Associates, Inc. AL0049-EN4 OCTOBER 2012
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