The Figulla Flex II device. Carlos AC Pedra, MD, PhD, FSCAI
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1 The Figulla Flex II device Carlos AC Pedra, MD, PhD, FSCAI
2 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 implants have been performed worldwide with the Figulla family of ASD and PFO occluders. CONFIDENTIAL - Occlutech All rights reserved. 2
3 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:
4 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 CONFIDENTIAL - Occlutech All rights reserved. 4
5 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 5
6 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 6
7 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 7
8 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 8
9 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 9
10 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 10
11 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 11
12 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 12
13 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:
14 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 14
15 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 15
16 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 16
17 Devices features The device design that contain less metal gives more device flexibility and less cutting edges CONFIDENTIAL - Occlutech All rights reserved. 17
18 Device features The ceramic titanium oxide surface gives the golden aspect of the nitinol wires The nitinol wires used for ASD/PFO devices are microns in diameter. The patch material is PET CONFIDENTIAL - Occlutech All rights reserved. 18
19 Device features The hubless left disc offers an atraumatic distal end entering the LA CONFIDENTIAL - Occlutech All rights reserved. 19
20 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 CONFIDENTIAL - Occlutech All rights reserved. 20
21 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 CONFIDENTIAL - Occlutech All rights reserved. 21
22 Shapeable cable CONFIDENTIAL - Occlutech All rights reserved. 22
23 Proprietary braiding technology The proprietary braiding technology of Occlutech gives a device that looks and behaves distinctly different from other self-centering nitinol occluders CONFIDENTIAL - Occlutech All rights reserved. 23
24 Devices features The Occlutech devices are less prone by design for mushroom effects upon oversizing, hence the 3 mm increments of size CONFIDENTIAL - Occlutech All rights reserved. 24
25 Sizes CONFIDENTIAL - Occlutech All rights reserved. 25
26 Sizes CONFIDENTIAL - Occlutech All rights reserved. 26
27 Sizes CONFIDENTIAL - Occlutech All rights reserved. 27
28 Multifenestrated defects. Flex Uni CONFIDENTIAL - Occlutech All rights reserved. 28
29 Multifenestrated defects. Flex Uni CONFIDENTIAL - Occlutech All rights reserved. 29
30 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 CONFIDENTIAL - Occlutech All rights reserved. 30
31 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
32 Device features A dedicated Occlutech Delivery system, including a braided delivery sheath, is available Perfecting Performance Occlutech Delivery Set CONFIDENTIAL - Occlutech All rights reserved. 32
33 Fenestrated device CONFIDENTIAL - Occlutech All rights reserved. 33
34 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 CONFIDENTIAL - Occlutech All rights reserved. 34
35 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 35
36 Use in challenging scenarios CONFIDENTIAL - Occlutech All rights reserved. 36
37 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 % (FDA erosion panel) CONFIDENTIAL - Occlutech All rights reserved. 37
38 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. CONFIDENTIAL - Occlutech All rights reserved. 38
39 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. CONFIDENTIAL - Occlutech All rights reserved. 39
40 Future improvement potential of ASD/ PFO devices Reduce metal content and still provide an easy to use and intuitive device. Endothelial accelerator coating CONFIDENTIAL - Occlutech All rights reserved. 40
41 Thank you for your attention! CONFIDENTIAL - Occlutech All rights reserved. 41
42 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 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
43 Time from implant to erosion Erosion data ;ASO devices (FDA erosion panel) CONFIDENTIAL - Occlutech All rights reserved. 43
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