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. CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 2
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. 3
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 4
Use in challenging scenarios CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 5
Use in challenging scenarios CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 6
Use in challenging scenarios CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 7
Use in challenging scenarios CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 8
Use in challenging scenarios CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 9
Use in challenging scenarios CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 10
Use in challenging scenarios CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 11
Use in challenging scenarios CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 12
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. 13
Use in challenging scenarios CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 14
Use in challenging scenarios CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 15
Use in challenging scenarios CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 16
Devices features The device design that contain less metal gives more device flexibility and less cutting edges CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 17
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 CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 18
Device features The hubless left disc offers an atraumatic distal end entering the LA CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 19
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 2012. All rights reserved. www.occlutech.com 20
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 2012. All rights reserved. www.occlutech.com 21
Shapeable cable CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 22
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 2012. All rights reserved. www.occlutech.com 23
Devices features The Occlutech devices are less prone by design for mushroom effects upon oversizing, hence the 3 mm increments of size CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 24
Sizes CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 25
Sizes CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 26
Sizes CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 27
Multifenestrated defects. Flex Uni CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 28
Multifenestrated defects. Flex Uni CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 29
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 2012. All rights reserved. www.occlutech.com 30
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. 31
Device features A dedicated Occlutech Delivery system, including a braided delivery sheath, is available Perfecting Performance Occlutech Delivery Set CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 32
Fenestrated device CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 33
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 CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 36
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) CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 37
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 2012. All rights reserved. www.occlutech.com 38
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 2012. All rights reserved. www.occlutech.com 39
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 2012. All rights reserved. www.occlutech.com 40
Thank you for your attention! CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 41
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) CONFIDENTIAL - Occlutech 2012. All rights reserved. www.occlutech.com 43