Prof. Dr. med. H. R. Figulla Director at the University Hospital Jena

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Presentation transcript:

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

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

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

Figulla PFO (flexible)®

Old technology

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

Amplatzer versus Figulla ASD Occluders 13.04.2018

Figulla Flex Occluders

Tunnel shaped PFO-device Figulla® Flex PFO Simulation of a tunnel shaped PFO defect. 2018-04-13 2018-04-13 12

Amplatzer ASD Notice the malaposition in LA 13.04.2018

Figulla® Flex PFO and Figulla® Flex ASD

Advantage: The new Occlutech connector means is without a traditional stainless steel hub. That means an important minimizing amount of material implanted. 2018-04-13 2018-04-13 17

Advantage: The new delivery system allows a tilt of up to 45° giving perfect placement prior to release 2018-04-13 2018-04-13 18

Flex Pusher – the new delivery cable Higher safeness during pushing the Occluder through the sheath. No unintended disconnection. 2018-04-13 2018-04-13 19

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 180d 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 13.04.2018

Figulla ASD Device Study Patients (n) SAE Residual Shunt Krizanic et al. J Invasive Cardiol. 2010 11 none 1 (9,1%) 180 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 13.04.2018 SAE (Severe Adverse Event): Major Bleeding, Stroke/TIA, Malposition, Death, Reoperation or Surgery needed, Embolization, Thrombus Formation, AF

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

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%) 180 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

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

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

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Occlutech LAA device 33

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

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

Animal trial (ovine) Occlutech LAA Device 36

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

Perfecting Performance“