The Figulla Flex II device
Carlos AC Pedra, MD, PhD, FSCAI
Flex II background
•  The Flex II (ASD and PFO devices)
represent the third generation of Occlutech
ASD and PFO occluders following the Figulla
N (CE marked in May 2007) and the Flex I
device.
•  20000 implants have been performed
worldwide with the Figulla family of ASD and
PFO occluders.
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Figulla N and I
Experience at IDPC and HCor
•  127 ASDs and 27 PFOs
•  1 embolization/1 mal position: retrieval
•  No erosion
•  2 residual leaks (additional small defects)
Pedra CAC, Braga SLN, Pedra SRFF, Costa RN, Braga SLN, Esteves CA, Fontes VF. Experiência Inicial
no Fechamento Percutâneo da Comunicação Interatrial Tipo Ostium Secundum com a Prótese. Rev Bras
Cardiol Inv 2010; 18: 81 – 88.
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Use in challenging scenarios
Pedra CAC, Pedra SF, Costa RN, Ribeiro M. The Occlutech Figulla Device. In: Sievert H, Qureshi S,
Wilson N, Hijazi ZM, Franke J, Bertog S (eds.). Percutaneous Interventions in Structural, Valvular and
Congenital Heart Disease. 2nd edition. Informa Healthcare. Oxford, UK. 2014.
CONFIDENTIAL - © Occlutech 2012. All rights reserved. www.occlutech.com
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Use in challenging scenarios
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Use in challenging scenarios
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Use in challenging scenarios
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Use in challenging scenarios
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Use in challenging scenarios
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Use in challenging scenarios
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Use in challenging scenarios
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Use in challenging scenarios
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Figulla N and I
Personal impressions
•  Flexible device (larger sizes)
•  No need for fancy maneuvers
•  Excellent for large defects in adults
•  Oversizing less of a problem?
Pedra CAC, Braga SLN, Pedra SRFF, Costa RN, Braga SLN, Esteves CA, Fontes VF. Experiência Inicial
no Fechamento Percutâneo da Comunicação Interatrial Tipo Ostium Secundum com a Prótese. Rev Bras
Cardiol Inv 2010; 18: 81 – 88.
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Use in challenging scenarios
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Use in challenging scenarios
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Use in challenging scenarios
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Devices features
The device design that
contain less metal
gives more device
flexibility and less
‘cutting’ edges
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Device features
The ceramic titanium
oxide surface gives
the ‘golden’ aspect of
the nitinol wires
The nitinol wires used
for ASD/PFO devices
are 40-200 microns in
diameter. The patch
material is PET
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Device features
The hubless left disc
offers an atraumatic
distal end entering the
LA
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Bioptome-type delivery system
•  Allows a full circular
movement of the
device
•  Lower tension in
the delivery system
means that ‘you
see what you get’
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Angled delivery system
• Less tension in the
delivery cable means
less flicking effect upon
device release
• Less need to force the
septum as the 50 degree
angle allows adaptation to
a large portion of septal
anatomies
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Shapeable cable
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Proprietary braiding technology
The proprietary
braiding technology of
Occlutech gives a
device that looks and
behaves distinctly
different from other
self-centering nitinol
occluders
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Devices features
The Occlutech devices
are less prone by
design for mushroom
effects upon
oversizing, hence the
3 mm increments of
size
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Sizes
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Sizes
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Sizes
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Multifenestrated defects. Flex Uni
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Multifenestrated defects. Flex Uni
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Sheath compatibility
•  The Flex II braiding
technique reduces
sheath requirements
on average 20% as
compared to Flex I.
•  This means the ASD
range going from
8-14 Fr to 7-12 Fr
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Sheath compatibility
Pedra CAC, Pedra SF, Costa RN, Ribeiro M. The Occlutech Figulla Device. In: Sievert H, Qureshi S,
Wilson N, Hijazi ZM, Franke J, Bertog S (eds.). Percutaneous Interventions in Structural, Valvular and
Congenital Heart Disease. 2nd edition. Informa Healthcare. Oxford, UK. 2014.
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Device features
•  A dedicated
Occlutech Delivery
system, including a
braided delivery
sheath, is available
Perfecting Performance
Occlutech® Delivery Set
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Fenestrated device
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Use in challenging scenarios
Pedra CAC, Pedra SF, Costa RN, Ribeiro M. The Occlutech Figulla Device. In: Sievert H, Qureshi S,
Wilson N, Hijazi ZM, Franke J, Bertog S (eds.). Percutaneous Interventions in Structural, Valvular and
Congenital Heart Disease. 2nd edition. Informa Healthcare. Oxford, UK. 2014.
CONFIDENTIAL - © Occlutech 2012. All rights reserved. www.occlutech.com
34
Use in challenging scenarios
CONFIDENTIAL - © Occlutech 2012. All rights reserved. www.occlutech.com
35
Use in challenging scenarios
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Can design features affect the rate of
EROSION?
•  Erosion is a rare but potentially catastrophic
complication of ASD/PFO closure
•  The literature and the MAUDE data base
puts the incidence at 1-2/1000 (ASO
devices), i.e. 0.1-0.2% (FDA erosion panel)
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Occlutech erosion statistics
•  With twenty thousand implants the real
incidence ‘should be’ 40 cases of erosions
•  The reported number of erosions of the
Figulla ASD/PFO occluders is ZERO. As a
European manufacturer following CE/ISO
rules, there is a complaint reporting system
in place.
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Ways to further investigate these data
•  Due to the rarity of erosion, it may not be
feasible to do a randomized trial. Also difficult
with registries.
•  An independent third party could audit
operators/hospitals and gather the data.
•  The company could also initiate a registry for
ASD implants with deficient rims.
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Future improvement potential of ASD/
PFO devices
•  Reduce metal content and still provide an
easy to use and ‘intuitive’ device.
•  Endothelial accelerator coating
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Thank you for your attention!
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Flex II background
The Flex II (ASD and PFO devices) represent
the third generation of Occlutech ASD and
PFO occluders following the Figulla N (CE
marked in May 2007) and the Flex I device.
20000 implants have been performed worldwide
with the Figulla family of ASD and PFO
occluders.
Pedra CAC, Pedra SF, Costa RN, Ribeiro M. The Occlutech Figulla Device. In: Sievert H, Qureshi S,
Wilson N, Hijazi ZM, Franke J, Bertog S (eds.). Percutaneous Interventions in Structural, Valvular and
Congenital Heart Disease. 2nd edition. Informa Healthcare. Oxford, UK. 2014.
42
Time from implant to erosion
Erosion data ;ASO devices (FDA erosion panel)
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