1. Prof. Dr. med. H. R. Figulla
Director at the University Hospital Jena
Germany
The Occlutech Innovations: ASD-,PFO-,LAA-Occluders, Aortic Enlarger Preventer

2. Hans R. Figulla, MD, PhD
Ownership Interest (stock, stock options, or other ownership interests):
JenaValve
Occlutech
Avidal

3. Difference - Comparison
Amplatzer
technology
tube
Figulla device®
(single-layer)
funnel
Figulla device®
(double-layer) for PFO and ASD
ball

5. Figulla PFO (flexible)®

8. Old technology

9. Difference - Comparison
old existing
technology
tube
Figulla device®
(single-layer)
funnel
Figulla device®
(double-layer) for PFO and ASD
ball

10. Amplatzer versus Figulla ASD Occluders

11. Figulla Flex Occluders

12. Tunnel shaped PFO-device
Figulla® Flex PFO
Simulation of a tunnel shaped PFO defect. 12

13. Amplatzer ASD
Notice the malaposition in LA

14. Figulla® Flex PFO and Figulla® Flex ASD

17. Advantage:
The new Occlutech connector means is without a traditional stainless steel hub. That means an important minimizing amount of material implanted. 17

18. Advantage:
The new delivery system allows a tilt of up to 45° giving perfect placement prior to release 18

19. Flex Pusher – the new delivery cable
Higher safeness during pushing the Occluder through the sheath.
No unintended disconnection. 19

20. Amplatzer Septal Occluder (ASD) Study Patients (n) SAE (n)
Residual Shunt
Knepp et al.
Congenital Heart Dis. 2010
159
5 (3,1%)
7 (4,4%) 30d
3 (1,9%) 180d
Elshershari et al. J Invasive Cardiol. 2008 41 1
(2,4%)
4 (9,8%) procedural
None d
Nigel et al. Heart Lung Circ. 2008
202 18
(8,9%)
19 (9,4%) procedural
5 (2,5%) 180d
Knepp et al. Congenit. Heart Dis. 2010 94 8
(8,5%)
7 (7,4%) procedural
1 (1,1%) 180d
SAE (Severe Adverse Event): Major Bleeding, Stroke/TIA, Malposition, Death, Reoperation or Surgery needed, Embolization, Thrombus Formation, AF

21. Figulla ASD Device Study Patients (n) SAE Residual Shunt
Krizanic et al.
J Invasive Cardiol. 2010 11
none
1 (9,1%) d
Ilkay et al. Turk Kardyol Dern Ars 2010 28 4
(14,3%)
3 (10,7%) procedural
None 180 d
Pac et al.
J Interv Cardiol 2009 33 5
(15,2%)
No Residual shunt 180 d
SAE (Severe Adverse Event): Major Bleeding, Stroke/TIA, Malposition, Death, Reoperation or Surgery needed, Embolization, Thrombus Formation, AF

22. Amplatzer PFO Device Study Patients (n) SAE Residual Shunt (n)
Von Bardeleben et al. Int. J Cardiol. 2009
199 7
5 (2,5%) procedural
5 (2,5%) 180 d
Saguner et al.
Catheter Cardiovasc Interv. 2010 20
none
Cifarelli et al.
Int J Cardiol. 2010
162 1
6 (0,6%) 180d
Greutmann et al. Congenit. Heart Dis. 2009
135
n.k.
26 (19%) 180d
SAE (Severe Adverse Event): Major Bleeding, Stroke/TIA, Malposition, Death, Reoperation or Surgery needed, Embolization, Thrombus Formation, AF

23. Figulla PFO Device Study Patients (n) SAE Residual Shunt (n)
Krizanic et al.
J Invasive Cardiol. 2010 27
none
Saguner et al.
Catheter Cardiovasc Interv. 2010 20 3
(15%)
2 (10%) d
Krizanic et al. Clin Res Cardiol. 2008 34
3 (8,8%)
4 (11,8%) 180 d
SAE (Severe Adverse Event): Major Bleeding, Stroke/TIA, Malposition, Death, Reoperation or Surgery needed, Embolization, Thrombus Formation, AF

24. Available sizes for PFO and ASD
23/25 mm (single-layer) ...max.13 mm
23/25 mm (double-layer) ...max.15mm, 27/30 mm (double-layer). ...max. 17mm ,large septal aneurysm
Sizes: 9,12,15,18,21,24,27,30
33,36,39,40 mm

25. Advantages of the Figulla Occluder
Little protrusion into the left atrium even when oversized
High flexibility
Great conformity to the atrial septum anatomy due to easy wire mesh reconfiguration
No left atrial hub
Pusher cable tilt during deployment
Disadvantages:
1-2 Fr greater delivery sheath

33. Occlutech LAA device 33

34. Occlutech LAA Device Feature
self-expanding, flexible Nitinol wire mesh
high radial forces due to conical shape and
using loops instead of barbs
NO PERFORATION
PU-coating for accelerated endothelialisation
and instantly sealed
AVOID THROMBUS FORMATION
using the new connection-system
HIGH FLEXIBILITY
NiTinol wire mesh
Occlutech LAA Device 34

35. Occlutech LAA Device Feature
size range: 7 sizes available: 15 – 33 mm
(3 mm increasement)
delivery system: 12 F – 14 F
Coated LAA 18 & 33
Occlutech LAA Device 35

36. Animal trial (ovine)
Occlutech LAA Device 36

37. 2011 – acute animal study (ovine) 2012 – animal study (ovine)
Time plan
2011 – acute animal study (ovine)
2012 – animal study (ovine)
2012 / – human study
2013 – CE-Mark
Occlutech LAA Device 37

38. Perfecting Performance“