The Next Generation of Patent Foramen Ovale and

The Next Generation of Patent Foramen Ovale and ASD Occlusion Device: The Figulla Occlutech Occluders Hans R. Figulla MD, Ph. D University Heart Center, Jena, Germany

Disclosures

Figulla® Flex – The new Generation ASD and PFO Occluders 3

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

Figulla PFO (flexible)®

Figulla PFO (flexible)® Old technology

Occlutech

PFO flexible PFO standard

Figulla® Flex PFO Simulation of a tunnel shaped PFO defect. 13

Old existing technology

Old technology Distance of layers from hole Figulla ASD Size of hole for 12 mm occluders

Advantage: The new Occlutech connector means is without a traditional stainless steel hub. That means an important minimizing amount of material implanted. 16

Advantage: The new delivery system allows a tilt of up to 45° giving perfect placement prior to release 17

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

Figulla ASD Device Study Patients (n) SAE (n) Residual Shunt (n) 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 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 0 none Cifarelli et al. Int J Cardiol. 2010 162 1 6 (0, 6%) 180 d Greutmann et al. Congenit. Heart Dis. 2009 135 n. k. 26 (19%) 180 d SAE (Severe Adverse Event): Major Bleeding, Stroke/TIA, Malposition, Death, Reoperation or Surgery needed, Embolization, Thrombus Formation, AF

Figulla PFO Device Study Patients SAE (n) Residual Shunt (n) Krizanic et al. J Invasive Cardiol. 2010 27 none Saguner et al. Catheter Cardiovasc Interv. 2010 20 3 (15%) 2 (10%) 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

Figulla Occlutech Occluders Available sizes for PFO and ASD PFO ASD 23/25 mm (single-layer). . . max. 13 mm 23/25 mm (double-layer). . . max. 15 mm, 27/30 mm (double-layer). . max. 17 mm, large septal aneurysm Sizes: 9, 12, 15, 18, 21, 24, 27, 30 33, 36, 39, 40 mm 30/33 mm (double layer)… cribiform septum, large septal aneurysm 23/25 mm (double layer) Flex D…tunel PFO Coming next: LAA-, PDA-Occluders

Thanks for Your Attention Figulla® Flex – The new Generation ASD and PFO Occluders 23

The Next Generation of PFO and ASD Occlusion Device: The Figulla Occlutech Occluders Hans R. Figulla Professor of Medicine University Hospital, Jena Germany

The Next Generation of Patent Foramen Ovale and ASD Occlusion Device: The Figulla Occlutech Occluders Hans R. Figulla, University Hospital, Jena , Germany

Figulla PFO (flexible)®