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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
Apposition of the GORE ® HELEX ®
Septal Occluder to the Atrial
Septum
• F E A T U R E D T O P I C
Airborne Observatory Relies
on Gore Cables to Collect
Data from Space
• I N T H E N E W S
Gore Receives Zero Reports
of Erosion Associated
with GORE ® HELEX ® Septal
Occluder
• U P C O M I N G E V E N T S
– Tradeshows
– GORE MEDICAL MASTERY
SERIES courses
P E R F O R M A N C E b y d e s i g n
C A S E S T U D Y
Apposition of the GORE ® HELEX ®
Septal Occluder to the Atrial Septum
Lourdes Prieto, MD
Cleveland Clinic Children’s Hospital
Cleveland, Ohio
The atrial septum is a three dimensional structure with varying topography.
The degree of curvature varies with location along the septum, and may also
be affected by a volume and / or pressure load on one or the other atrium,
resulting in atrial septal “bowing”. Specifically, the superior portion of the
septum adjacent to the superior vena cava is typically characterized by a mild
curvature from left-to-right. Percutaneous ASD closure with all the currently
available devices requires that the device discs are oversized as compared with
the defect.
Continued on inside cover...
goremedical.com/HELEX
Fall 2011 • Issue XVI

Apposition of the GORE ® HELEX ® Septal Occluder to the Atrial Septum
Continued from cover...
Figure 1. Subcostal short axis view demonstrating
the ASD with adequate superior (SVC) and
postero-inferior (IVC) rims measuring 7 mm and
12 mm respectively. (IVC = inferior vena cava,
LA = left atrium, RA = right atrium, SVC = superior
vena cava.
Figure 2. Parasternal short axis view demonstrating
the deficient antero-superior (aortic) rim measuring
3 mm. ASD = atrial septal defect, LA = left atrium,
RA = right atrium.
Figure 3. ICE image demonstrating the stop-flow
diameter of the ASD measured at 11.6 mm.
The extent to which the portion of the
discs around the defect conforms to the
atrial septal surface is determined by the
anatomy of that surface, the mechanism
by which the device closes the defect,
and the structure of the device.
The GORE ® HELEX ® Septal Occluder is a
non-self centering device with left and
right atrial discs that will generally
conform to the atrial septal surface.
Despite these features, it is sometimes
observed that the superior portion of the
right atrial disc along the SVC rim does
not appose well to the septum, as the
device cannot bend to follow the atrial
septal curvature. The device may then
appear to protrude towards the SVC.
Although this appearance may raise
concern about interference with SVC
flow, to date we have not encountered
a case where obstruction of SVC
flow was observed clinically or
echocardiographically. We have been
careful to interrogate the SVC flow by
color and pulse Doppler with either
TEE or ICE (one or the other imaging
technique is used for all septal closures
in our practice) in the catheterization
laboratory after locking the device as
well as after full release, and no
significant obstruction has ever been
detected. Over time some patients
demonstrate improved apposition of the
right atrial disc of the device towards the
septum, but even when that does not
occur there have been no cases of
compromised SVC flow during follow-up.
The following case illustrates the
above observations:
A seven-year-old girl with a small to
moderate secundum atrial septal defect
and very mild pulmonary valve stenosis
presented for device closure. The defect
measured 7 – 8 mm by transthoracic
echocardiogram and the right ventricle
was enlarged. The ASD had adequate
superior (SVC) and postero-inferior (IVC)
rims (Figure 1), and relatively deficient
antero-superior (aortic) rim (Figure 2).
At catheterization a Q p
/ Q s
of 1.6 was
measured under general anesthesia. A
5 mm gradient was measured across the
pulmonary valve. Pulmonary angiography
demonstrated mild doming of the
pulmonary valve and a relatively centrally
located atrial septal defect with
moderate opacification of the right
ventricle. Intracardiac echocardiography
(ICE) was utilized to guide the procedure
along with fluoroscopy. Evaluation of the
rims confirmed the previously described
findings. The stop flow diameter was
measured at 11 – 12 mm (Figure 3).
A 25 mm GORE ® HELEX ® Device was
chosen and successfully deployed
around the aortic knob (Figure 4,
Video 1*).
The superior portion of the right atrial disc
of the device around the SVC rim did not
appose optimally to the right side of the
atrial septum and protruded mildly
towards the SVC. Color flow demonstrated
no turbulence with laminar flow from the
SVC to the right atrium. Right atrial
angiography demonstrated a wellpositioned
device with again some
protrusion of the superior right atrial disc
towards the SVC (Figure 5, Video 2*).
No residual leak was identified by ICE or
angiography. A transthoracic echocardiogram
the following morning continued
to demonstrate no residual leak and

Video 1*. ICE image post GORE ® HELEX ® Septal
Occluder deployment demonstrating the device
discs “hugging” the aorta. LA = left atrium,
RA = right atrium.
Video 2*. Right atrial angiogram in left
anterior oblique / cranial angulation following
the GORE ® HELEX ® Septal Occluder deployment
shows no residual leak on levophase, and mild
protrusion of the superior RA disc towards the SVC.
Figure 4. ICE image post GORE ® HELEX ® Septal
Occluder deployment demonstrating the device
discs “hugging” the aorta. LA = left atrium,
RA = right atrium.
protrusion of the superior portion of the
device into the SVC with no obstruction
to SVC flow (Figures 6 – 7; Video 3*).
The patient has been followed for
one year and is doing well clinically.
Device position appears unchanged by
echocardiogram with persistent mild
protrusion into the SVC without flow
compromise (Figure 8 – 9; Video 4*).
Right ventricular size and septal motion
are normal. One possible concern
regarding persistent protrusion of the
device and lack of apposition to the
septum is whether endothelialization
of the portion of the device not in contact
with the septum will occur. Experience
with animal studies using devices that
are too large for the size of the atrial
septum, and therefore having a flared
appearance with suboptimal apposition
around the defect, have shown that
areas of the device not in contact with
the septum are covered with a similar
layer of fibrous connective tissue and
endothelial-like cells at portions making
contact. In these animals, improved
apposition of the atrial disc of the device
to the septum was observed over time.
We have not seen any instances of
thrombus formation on protruding portions
of the device, nor have any of our patients
experienced a clinical event suggestive of
pulmonary or systemic emboli.
In summary, mild protrusion of portions
of the GORE ® HELEX ® device into the
right or left atria may occur due to the
septal topography, or sometimes when
devices are relatively large for the
size of the heart. Provided there is no
interference with any intracardiac
structure, or obstruction to systemic or
pulmonary venous return at the time of
deployment, these protrusions do not
result in any clinical problem. In some
cases there is improved apposition of the
atrial disc of the device to the atrial
septum over time.
Please refer to GORE ® HELEX ® Septal
Occluder Instructions for Use at
goremedical.com for a complete
description of all indications,
contradindications, warning,
precautions and adverse events.
This case study is not intended to
express the views, opinions, or
Figure 5. Still frame fluoroscopic image in the
lateral projection showing a well positioned
GORE ® HELEX ® Device with some protrusion of the
superior RA disc towards the SVC. ICE = intracardiac
echocardiography, LA = left atrium, RA = right atrium.
recommendations of the device
manufacturer, W. L. Gore & Associates,
rather the views, opinions, or
recommendations expressed herein
are exclusively the authors’ own,
and Gore excepts no liability for the
accuracy or completeness or use of the
information contained in this article.
Continued on next page...

Apposition of the GORE ® HELEX ® Septal Occluder to the Atrial Septum
Continued from previous page..
Figure 6.
Figure 8.
Figure 7.
Figure 9.
Video 3*. Subcostal long and short axis views (Figures 6, 7, Video
3*) obtained 24 hours after ASD closure demonstrating protrusion
of the device towards the base of the SVC. Color Doppler shows
laminar flow with no evidence of obstruction to SVC flow. (LA = left
atrium, RA = right atrium,
SVC = superior vena cava).
Video 4*. Subcostal long and short axis views (Figures 8, 9, Video 4*)
one year after ASD closure demonstrating persistent protrusion of
the device towards the SVC. Color Doppler again shows laminar flow
with no evidence of obstruction to SVC flow. (LA = left atrium, RA =
right atrium, SVC = superior vena cava).
* The video files referenced in these articles are
available in our online version of the Closing Remarks
newsletter: http://www.goremedical.com/HELEX/
library/newsletters.

F E A T U R E D T O P I C
Airborne Observatory Relies on Gore Cables
to Collect Data from Space
High above the earth’s stratosphere, a
Boeing 747 jet is gathering information
about star and planet formation millions
of light-years away. The heavily modified
jet is equipped with an infrared telescope
that relies on Gore cables to capture data.
Called the SOFIA project, the endeavor
is a joint collaboration between the
U.S. National Aeronautics and Space
Administration (NASA) and the German
Aerospace Center. Gore became involved
with the project shortly before the first
science mission, helping to solve a
critical need after a competitor’s cables
failed to perform as required.
Application engineer Robert John, explains,
“When the competitor’s cables flexed,
this altered the data being collected.
It was a significant problem, because
the cables were an integral part of the
mission. They were going to transmit
data for analysis, and excessive distortion
of that data was unacceptable.”
Meeting a Critical Need
The SOFIA aircraft is an airborne
observatory designed to analyze infrared
light to learn more about the formation of
stars and planets; the composition of
comets, asteroids and planets; and black
holes at the center of galaxies. Because it
reaches altitudes of nearly 45,000 feet
into the stratosphere, it has greater
access to the infrared wavelengths
needed to collect such data. At lower
altitudes, these wavelengths are blocked
by water in the earth’s atmosphere.
In order for the aircraft to collect data,
it needs cables that easily flex as the
infrared telescope rotates. And the cables
must maintain a reliable signal while
flexing. When the competitor’s cables
failed to maintain their signal, the SOFIA
project team turned to Gore. They already
had access to GORE ® PHASEFLEX ®
Microwave / RF Test Assemblies in one of
their facilities and conducted preliminary
testing to see if the product would meet
their need. Encouraged by the results,
they sought more information.
Sales associate Steve Barrett, California,
traveled to the southern California facility
where the SOFIA project isheadquartered.
“They took me into the aircraft, showed
me the application and explained what
they needed. The project required 30- to
50-foot long cables, and although they
had tested a much shorter version of our
product, they knew it had potential.”
With their unique materials and
construction, GORE ® PHASEFLEX ®
Microwave / RF Test Assemblies bend
and flex without sacrificing performance.
And although lightweight and flexible,
they are also highly durable and made
to withstand harsh environments.
Delivering on Commitments
After learning more about the product’s
capabilities, the SOFIA project team
selected Gore’s cables to solve their
problem. But to launch their first mission
on time, they needed the cables within
just two weeks.
“That’s a very quick turnaround time,
particularly for long cables, which are
more difficult to process,” Robert says.
“We also needed to prepare the cables
for high altitudes environments, which
adds more time to the process.”
Despite the considerable work required,
Gore manufactured the cables and
completed all necessary testing on time,
enabling the SOFIA mission to launch
on schedule. “This wouldn’t have been
possible without incredible teamwork
from everyone within the product line.
They dove right into the project and
followed through on all of the
commitments made,” Robert says.
“Many functions played a role, including
manufacturing, sales, engineering and
quality. It was a true team effort and an
example of the level of customer service
we pride ourselves on delivering.”
In early April, the SOFIA project
conducted its first astronomy mission,
gathering information about star
formation in a constellation 11 million
light-years from earth and in a cloud
5,000 light-years away.
The SOFIA aircraft is expected to embark
on nearly 3,000 flights over the next 20
years, and Gore may have additional
opportunities to provide more cables for
the project. “The scientists involved were
very appreciative of our efforts, and I’m
confident that we’ve won over some new
fans that are sure to contact Gore to
satisfy their future needs,” Robert says.

I N T H E N E W S
Gore Acquires Intellectual Property of NMT Medical, Inc.
CLOSURE I Trial Data May Create Better Clinical Understanding of Patent Foramen Ovale (PFO) in Stroke Patients
FLAGSTAFF, Arizona — October 19, 2011 — W. L. Gore & Associates (Gore) announced that the Company has purchased
the assets and intellectual property of NMT Medical, Inc., including the data related to CLOSURE I, a prospective,
multi-center, randomized controlled trial of PFO closure with the STARFLEX ® Device (NMT Medical, Inc) versus best medical
therapy for the prevention of recurrent stroke and /or transient ischemic attack (TIA) in patients with cryptogenic stroke /
TIA and PFO.
“We made the decision to acquire these assets in the spirit of collaboration and in the interest of advancing scientific
and medical understanding,” said Stuart Broyles, PhD, Associate with the Gore Medical Division Stroke Business. The
study data were acquired with the rest of the NMT assets, but the transaction did not transfer any liabilities or regulatory
obligations of NMT.
The acquisition came after NMT ceased operations earlier this year.
ABOUT W. L. GORE & ASSOCIATES
The Gore Medical Products Division has provided creative therapeutic solutions to complex medical problems for more
than 35 years. During that time, more than 30 million innovative Gore Medical Devices have been implanted, saving
and improving the quality of lives worldwide. The extensive Gore Medical family of products includes vascular grafts,
endovascular and interventional devices, surgical meshes for hernia repair, soft tissue reconstruction, staple line
reinforcement and sutures for use in vascular, cardiac and general surgery. Gore was recently named one of the best
companies to work for by Fortune magazine for the 14th consecutive year. For more information, www.goremedical.com.

Gore Receives Zero Reports of Erosion Associated
with GORE ® HELEX ® Septal Occluder
Worldwide Data Provides Confidence in Device as Permanent Heart Implant
On August 22, 2011, W. L. Gore & Associates (Gore) reported that it has received
zero accounts of erosion of the aortic root or the free wall of the atrium associated
with the worldwide use of the GORE ® HELEX ® Septal Occluder. The positive data
comes from more than a decade of clinical experience using the Gore Device.
This is encouraging news for the thousands of patients treated with the GORE ®
HELEX ® Septal Occluder to close the genetic condition of atrial septal defect (ASD),
an abnormal hole in the wall between the heart’s upper chambers. Leading
cardiologists with experience using the Gore Device credit these outcomes with
expanded polytetrafluorethylene (ePTFE) material, a biocompatible material that
allows tissue ingrowth to seal the defect.
“I have now used the GORE ® HELEX ® Device in more than 250 patients with excellent
results. The complication rate is low and the closure rate is high,” said Ziyad M.
Hijazi, MD, Course Director, PICS; Director, Rush Center for Congenital and Structural
Heart Disease, Professor of Pediatrics and Internal Medicine, and Section Chief
Pediatric Cardiology at Rush University Medical Center in Chicago. “When treating an
ASD, if the Gore Device is appropriate, I will use it right away as the material is very
soft and conforms to the shape of the hole. The GORE-TEX ® material is key.”
“The GORE ® HELEX ® Septal Occluder is a device made mostly of GORE-TEX ® patch
and minimal metal frame. It poses a low risk of thrombus formation on the disc,
atrial arrhythmia complications from the device, and no reported cases of injury to
the heart wall resulting in perforation, a potentially life-threatening complication,”
stated John F. Rhodes, MD, Associate Professor in Pediatrics and Medicine at Duke
University, Chief of the Children’s Heart Center, and Director of the Pediatric and
Adult Congenital Cardiac Catheterization Laboratory in Durham, North Carolina.
According to Thomas Forbes, MD, Director, Cardiac Catheterization Laboratory at
Children’s Hospital of Michigan in Detroit; and Assistant Professor of Pediatrics
at Wayne State University in Detroit, “There is no question that the GORE ® HELEX ®
material is more conformable to the atria. The material’s mid and long term
closure performance has been proven. I have treated hundreds of patients with
the Gore Device and they have done extremely well. Overall, I am very happy with
the experience.”
The GORE ® HELEX ® Septal Occluder is a permanently implanted prosthesis and
catheter delivery system, with deployment via standard femoral venous access.
First cleared for use in Europe in 1999 and approved by the FDA in 2006, the
occluder is composed of ePTFE material supported by a single nitinol wire frame.
Over the course of several weeks to months following implantation of the device,
cells begin to infiltrate and grow over the ePTFE material, aiding in the successful
closure of the defect.
“When treating an
ASD, if the Gore
Device is appropriate,
I will use it right away
as the material is very
soft and conforms to
the shape of the hole.
The GORE-TEX ®
material is key.”
– Ziyad M. Hijazi, MD
“Gore is committed to long term performance and quality in ensuring positive
patient outcomes,” said Stuart Broyles, PhD, Associate with the Gore Medical
Division Stroke Business. “Material matters, and we are pleased that the data
regarding our signature ePTFE material in the unique GORE ® HELEX ® Septal Occluder
proves it.”

U P C O M I N G E V E N T S
Please Join Us...
Society of Cardiovascular Angiography and Interventions (SCAI )
Fall Fellows Symposium
December 4 – 9 Chicago, Illinois
Transcatheter Cardiovascular Therapeutics (TCT)
Booth #2017
November 7 – 11 San Francisco, California
2011 Scheduled GORE MEDICAL MASTERY SERIES Courses Sponsored by Gore
October 19* Chicago Atrial Septal Defect Closure Course with a Lab
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.
* space is limited
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.
GORE ® , GORE-TEX ® , HELEX ® , PHASEFLEX ® , PERFORMANCE BY DESIGN, and designs are trademarks of W. L. Gore & Associates.
STARFLEX ® is a trademark of NMT Medical, Inc.
© 2011 W. L. Gore & Associates, Inc. AQ4758-EN1 SEPTEMBER 2011