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Closing Rem a rk s
In This
I S S U E
• C A S E S T U D Y
Closure of an Ostium Secundum
ASD in a Child with Version 2.0 of
the GORE ® HELEX Septal Occluder
• F E A T U R E D T O P I C
Technical Footwear Business
Commemorates 20 Years
in Europe
• I N T H E N E W S
Gore Launches Improved GORE ®
HELEX Septal Occluder Delivery
System in the US and in Europe
P E R F O R M A N C E b y d e s i g n
• U P C O M I N G E V E N T S
C A S E S T U D Y
Closure of an Ostium Secundum ASD
in a Child with Version 2.0 of the
GORE ® HELEX Septal Occluder
Zartner P, Wiebe W, Toussaint-Goetz N, Schneider M
German Paediatric Heart Centre, Sankt Augustin, Germany
A nine year old boy presented to our laboratory with a 9 mm ostium secundum atrial
septal defect (ASD II). His body weight was 39 kg, and his length was 145 cm. The
right ventricle showed moderate enlargement with minimal tricuspid regurgitation.
There were no signs of pulmonary hypertension. His exercise tolerance was not
limited. We elected to close the ASD II with a device because of the increasing right
ventricular volume load. Informed consent was obtained from the parents.
Continued on inside cover...
goremedical.com/HELEX
Spring 2011 • Issue XIII

Closure of an Ostium Secundum ASD in a Child with
Version 2.0 of the GORE ® HELEX Septal Occluder Continued from cover...
The procedure was undertaken under
general anesthesia. Transesophageal
echocardiography demonstrated a
6 mm rim near the aortic root and a
total septal length of 42 mm in the
4-chamber view. We confirmed that
the pulmonary veins drained to the
left atrium. The Eustachian valve was
noted to bulge a little towards the
tricuspid valve, but it did not cause any
turbulence and was distant from the
atrial septum. The distance between the
defect and the AV-valves was 10 mm
and 12 mm to the tricuspid valve and
the mitral annulus, respectively. There
was a notable amount of left to right
shunt across the ASD with a maximum
flow of 1.6 m / s. The pulmonary valve
showed minimal regurgitation and was
mildly enlarged, compared with the
aortic root. Biventricular function was
unrestricted and within the normal
range.
The left femoral vein was punctured
and an 8 Fr short introducer sheath
was inserted. Following an assessment
of pressures and blood saturations, it
was concluded that a significant left to
right shunt was present necessitating
device closure. 1.5 g of cefuroxim and
100 units / kg of heparin were given.
Then, a stiff 0.035” guide wire was
placed across the defect into the left
upper pulmonary vein. Using a 20 mm
sizing balloon, the mildly stretched
diameter of the defect was evaluated
by echocardiography and angiography
simultaneously. Defect measurements
ranged from 10 to 12 mm. To fulfill
the criteria of a 2:1 device diameter to
defect diameter sizing ratio, we elected
to implant a 25 mm GORE ® HELEX
Septal Occluder. The 8 Fr short sheath
Figure 1: Transthoracic echocardiography revealed a 10 mm ASD II with
left to right shunting and enlargement of the right atrium and ventricle.
The overall atrial septal length was estimated as 4.2 cm.
Figure 2: Pre-interventional transesophageal echocardiography
confirmed the transthoracic findings. The ASD II measured as 9 mm
and with sufficient rims.

was exchanged for a 10 Fr introducer in
preparation for delivery of the device.
Figure 3: After measuring the oxygen saturations and calculating the
shunt volume, balloon sizing was performed. The balloon is inflated
until a distinctive waist was seen.
Figure 4: Invasive balloon sizing was accompanied by transesophageal
measurements of the balloon’s waist until a significant reduction of the
shunt has been observed. In this case, the defect measured 10 mm by
fluoroscopy and 9.2 mm by echocardiography.
The 25 mm GORE ® HELEX Septal
Occluder was loaded into its green
delivery catheter. The guide wire was
retrieved and the delivery system
advanced through the defect to the left
atrium. All further steps were performed
under fluoroscopy and were controlled
by transesophageal echocardiography.
The left disc was deployed step by
step using the repeated push-pinchpull
technique and then subsequently
retracted to the atrial septum.
Echocardiography revealed that the left
disc was unequally deployed across the
atrial septum, with approximately half
of the device in the left atrium and the
other half prolapsed across the atrial
septum. Thus, it was decided to retrieve
and reposition the left atrial disc.
These maneuvers were aided by the
improved device’s features including
the stiffened, radiopaque mandrel and
the hydrophilic lubricious coating that
resides on the gray control catheter.
Following successful deployment of
the left disc, the device was again
drawn back to the atrial septum. It
was noted that the left disc apposed
the septum well. The right atrial
disc was subsequently deployed by
first withdrawing the green delivery
catheter and then advancing the
gray control catheter. After having
unscrewed the mandrel luer, all three
eyelets adjusted well in the center of
the device. The position of the device
relative to all cardiac structures was
evaluated by echocardiography. After
final confirmation that the device was
appropriately placed, the mandrel was
sharply pulled to release the device.

This resulted in all three eyelets being
successfully captured by the locking
loop. There was no residual shunt
around the device and its proper
position was documented.
The patient received 400 units / kg of
heparin for 24 hours and 200 units / kg
for another day. Antibiotics were
repeated twice during the first 24 hours.
Transthoracic echocardiography showed
a good result with no residual shunt.
The patient was dismissed 48 hours
after the procedure.
Discussion:
This was our first implantation of
Version 2.0 of the GORE ® HELEX Septal
Occluder. Several modifications of
the prior version have been made by
W. L. Gore & Associates to improve
the handling of the delivery system.
Specifically, the mandrel has been
reinforced by a stainless steel wire to
prevent potential kinking. This issue
intermittently occurred with the previous
version when the distal end of the
mandrel was sharply bent or pushed
forward during the delivery procedure.
The result of a kinked mandrel included
an inability to properly configure the
left-sided disc, thus alleviation of this
potential issue with the new version of
the device is a beneficial improvement.
Despite the mandrel stiffener, it is still
recommended to not push the mandrel
forward during the procedure, which
is under normal circumstances an
unnecessary maneuver.
As a second modification, the gray
control catheter of the improved device
now has a hydrophilic lubricious coating
intended to decrease the frictional
forces within the delivery catheter.
This markedly improves the kinesthetic
feel with which the device may be
deployed. In our case, the decreased
Figure 5: In the first attempt, the device was noted to be unequally deployed
across the septum. The device was completely reloaded into the delivery
catheter and a second attempt was initiated.
Figure 6: Under echocardiography guidance, the left side of the
GORE ® HELEX Device showed a flat configuration and was noted to be
well-apposed to the atrial septum.
Figure 7: Following deployment of the right disc, echocardiography
revealed that the device was in good position, capturing the septal tissue.
No residual shunt was seen.

friction contributed to a non optimal
configuration of the left disc. However,
this was easily corrected by controlling
both the gray control catheter and the
green delivery catheter together during
the deployment of the left atrial disc.
Figure 8: Fluoroscopy demonstrated normal configuration of the
GORE ® HELEX Septal Occluder.
The third modification to the device
includes the substitution of the existing
retrieval cord with a stronger cord.
This component, as with the previous
version of the device, enables retrieval
of the device after full deployment
and release from the delivery system.
The modified retrieval cord allows for
higher tensile forces to be applied
before a potential cord break occurs.
In our experience this might become
important if the device got entangled
within intra-atrial structures, like the
Eustachian valve. In this case, higher
forces may be needed to overcome the
resistance and pull the device down to
the inferior vena cava for retrieval into
the delivery catheter.
Conclusion:
Figure 9: Following lock release, the locking loop was noted to have
captured all three eyelets.
Figure 10: Echocardiography revealed the final position of the device
following removal of the retrieval cord. The right and left discs were in
good apposition with the atrial septum, and no residual shunt was noted.
The modifications embodied in Version
2.0 of the GORE ® HELEX Septal Occluder
offer a series of noted benefits without
significantly altering the implantation
procedure associated with deployment
of the device. These modifications
enhance the usability of the device by
reducing the rate for potential delivery
system issues. Overall the new delivery
system supports straight forward
implantation procedures with a good
final result more so than the previous
versions of the GORE ® HELEX Septal
Occluder.
Please refer to GORE ® HELEX Septal
Occluder Instructions for Use at
goremedical.com for a complete
description of all indications,
contraindications, warnings,
precautions and adverse events.

F E A T U R E D T O P I C
Technical Footwear Business Commemorates 20 Years in Europe
Serves Military and Workforce Markets
“Soaking wet, full of blisters and
generally sore”—this is how a German
military major described the condition of
his soldiers’ feet following a high-altitude
mission in the rain and snow more than
two decades ago. In fact, their feet were
so wet and wounded they had to cancel
their mission.
This negative experience led to a
partnership between Gore and the German
Armed Forces, and, ultimately, to the first
commercialized GORE-TEX ® footwear
product within Europe’s Technically
Oriented Fabrics business unit.
That product—a waterproof mountaineer
boot for Germany’s Federal Defense Force—
paved the way for additional contracts with
European military units, as well as various
sectors of the European workforce.
“Our level of innovation, our outstanding
technology and the quality and durability
of our products set us apart from
competitors,” says European Footwear
business leader Günter Nötzold.
Meeting Diverse Needs
When the technical footwear business
first began, it leveraged resources from
Gore’s consumer footwear business,
which already had a presence in the
United States and Europe. Today, these
businesses continue to benefit from a
number of the same tools, such as the
“whole boot comfort test” designed
to measure breathability. But each
business also has its own set of unique
resources, based on customer and
enduser requirements.
Günter, who started in consumer
footwear, says the growth of technical
footwear over the past two decades
has exceeded expectations. He adds,
“The reaction from end-users is always
very positive. They comment on how
comfortable and reliable our footwear is.”
There are more than 450 styles of
GORE‐TEX ® footwear for the military and
workplace markets in Europe. End-users
include firefighters, law enforcement
Firefighters in Reutlingen, Germany, are among
the many who rely on GORE-TEX ® footwear to
keep their feet comfortable and safe. The brand
is the market leader in the firefighting and police
segments in Germany.
officials, construction workers and railway
workers, among others. “We strive to
maintain optimum skin temperature and
humidity under all conditions and in all
categories,” Günter says.
To meet the diverse needs of different
end-users, three product classes exist: one
for use in cold weather, another for use in
moderate to warm weather and another
for use in changing weather conditions. In
addition to protecting against the weather,
GORE‐TEX ® footwear also protects against
chemicals and bloodborne pathogens in
certain applications.
“We work hard to understand the specific
needs of each end-user,” Günter says.
“Whether you’re exposed to freezing cold
temperatures, the desert heat or chemical
and biological agents, we have a solution
engineered for you.”
Collaborating with
Manufacturers and End‐users
One reason GORE‐TEX ® footwear stands
apart from competing products, Günter
says, is because Gore works closely
with manufacturers to ensure consistent
quality across all brands.
“In the 1990s, as more shoes with
GORE‐TEX ® membranes were being
worn in the workplace, the difference in
quality among these shoes was becoming
greater,” he says. “This was almost
always attributed to the way our materials
were built into the finished product. We
started working with the manufacturers
to make sure that the finished shoe had
the same water-repellent and breathable
properties as our membranes. Only those
shoe manufacturers who meet our quality
assurance standards are granted a
license to use our footwear laminate.”
Gore also works closely with end-users
to ensure that their needs are met.
Gore associate Michael Haag recalls
one notable example—a partnership
with Swiss Railways in the mid-1990s
that helped cut down on injuries and
employee absences.
“At the time, the number of accidents
per 100 employees at Swiss Railways
had reached 13.8—this was significantly
higher than the accident rate of the
American railways or British Rail,” he says.
“As a result, Swiss Railways decided to
equip those who worked in particularly
dangerous areas with safety boots. Their
goal was to reduce the number of working
days lost due to foot or leg injuries by
50 percent within two years. In order to win
over those employees who weren’t happy
about the idea of wearing safety boots
and to determine the exact requirements
of the boots, we conducted trials with
employees. After two years, the goal
had been accomplished—half as many
work days were lost. This prompted the
German and Austrian railways to procure
similar footwear for their employees.”
Looking Ahead
The technical footwear business is
working to develop new technologies in
all three of its product classes. “We’ve
accomplished a lot during the past two
decades, and we are extremely optimistic
about the future,” Günter says. “We
have established long-term partnerships
with many of Europe’s top footwear
manufacturers. People throughout
Europe in a variety of industries trust our
technology to keep their feet comfortable
and protected. We look forward to
building upon these relationships, as
well as expanding into new markets.”

I N T H E N E W S
Gore Launches Improved GORE ® HELEX Septal
Occluder Delivery System in the US and in Europe
W. L. Gore & Associates is pleased to announce the launch of an improved
iteration of the GORE ® HELEX Septal Occluder. The rollout of the improvement
has begun in the United States and in Europe and its availability will open up
to other markets pending respective regulatory approvals.
The new version incorporates various design changes to the delivery system
that are intended to enhance deployment consistency and the overall
robustness of the delivery system. The occluder remains unchanged.
Additionally, these improvements minimize the impact on the deployment
technique as compared to the current version. Thus, only minimal changes
to the Instructions for Use (IFU) accompany the device modifications. Please
refer to the GORE ® HELEX Septal Occluder IFU for details.
Changes to the delivery system and their intended benefits, includes:
• Addition of Lubricious Coating to the Control Catheter – Reduces
friction within the delivery system throughout loading, deployment and
repositioning of the Occluder
• Inclusion of Stiffening Wire within the Mandrel – Provides tactile
feedback to serve as a cue during loading and repositioning; Enhances
the fluoroscopic appearance of the Mandrel; Fortifies the Mandrel’s
resistance to kinking
• Strengthening of the Retrieval Cord – Improves the robustness of the
Retrieval Cord; Maintains ability to allow tension-free confirmation of
device position after lock release and easy retrieval, if necessary
This improvement marks a continued commitment by Gore to enhance the
user’s experience when delivering the GORE ® HELEX Septal Occluder. As with
previous iterations of the device, the implant remains a soft and conformable
option for the closure of atrial septal defects, having an extensive history
demonstrating excellent safety and performance.
Your local Gore Sales Associates will assist you with updating your
order information in order to obtain access to the improved iteration of
the GORE ® HELEX Septal Occluder. Please contact your local Gore Sales
Associates regarding any questions you may have about this improvement.
This improvement
marks a continued
commitment by
Gore to enhance
the user’s
experience when
delivering the
GORE ® HELEX
Septal Occluder.

U P C O M I N G E V E N T S
Please Join Us...
The Society for Cardiovascular Angiography (SCAI)
May 4 – 7, 2011 Baltimore, Maryland
Pediatric Inteventional Cardio Society (PICS)
July 24 – 27, 2011 Boston, Massachusetts
Congenital and Structural Interventions (CSI - iCi)
June 22 – 25, 2011 Frankfurt, Germany
2011 GORE MEDICAL MASTERY SERIES Courses
Atrial Septal Defect Closure
July 14 – 15
Detroit, Michigan
August 18 – 19 Chicago, Illinois
September 8 – 9 Detroit, Michigan
October 20 – 21 Chicago, Illinois
Gore’s commitment to excellence continues with the GORE MEDICAL MASTERY SERIES.
The Atrial Septal Defect Closure courses provide Interventional Cardiologists with the
opportunity to develop their knowledge of implant techniques. Contact your local Gore
Sales Associate for further information regarding these various course opportunities.
If you have a topic that you would like us to consider in a future issue of Closing Remarks,
please contact your local Gore Sales Associate or e-mail ClosingRemarks@wlgore.com
W. L. Gore & Associates, Inc.
Flagstaff, AZ 86004
+65.67332882 (Asia Pacific) 800.437.8181 (United States)
00800.6334.4673 (Europe) 928.779.2771 (United States)
goremedical.com
INDICATIONS FOR USE IN THE US: The GORE ® HELEX Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter
closure of ostium secundum atrial septal defects (ASDs). INDICATIONS FOR USE UNDER CE MARK: The GORE ® HELEX Septal Occluder is a permanently
implanted prosthesis indicated for the percutaneous, transcatheter closure of atrial septal defects (ASDs), such as ostium secundum and patent foramen
ovale. Refer to Instructions for Use at goremedical.com for a complete description of all contraindications, warnings, precautions and adverse events.
Products listed may not be available in all markets.
AMPLATZER ® is a trademark of AGA Medical Corporation.
GORE ® , GORE-TEX ® , HELEX, PERFORMANCE BY DESIGN, and designs are trademarks of W. L. Gore & Associates.
© 2011 W. L. Gore & Associates, Inc. AQ4478-EN2 APRIL 2011