The tailored solution for your bifurcation therapy
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1 The tailored solution for your bifurcation therapy
2 The tailored solution for your bifurcation therapy Dedicated self-expanding platform that conforms to the specific bifurcation anatomy Full bifurcation lesion coverage without creating a false carina Bifurcation DES technology Complete reconstruction possible
3 Proven safety of a dedicated bifurcation DES with an abluminal biodegradable polymer MACE (Death, MI, id-tlr) at 3 years 1 Confirmed safety in DIVERGE The use of Axxess for the treatment of complex bifurcation lesions resulted in low 3-year event rates, with a cumulative MACE rate of 16.0% Cumulative incidence (%) Primary endpoint MACE at 9 months 2 7.7% 9.3% Months of follow-up 14.0% n= % Proven efficacy of the Biolimus A9 drug Very low restenosis rate in bifurcation lesions Restenosis in DIVERGE at 9 months 2,4 Low in-stent late loss in DIVERGE at 9 months 2 In-stent late loss (prox. main branch) Proximal edge: 2.8% Axxess: 0.7% mm SB Cypher: 4.8% Any in-segment bifurcation restenosis: 6.4% Distal PV Cypher: 2.1% DIVERGE 9 months Axxess SIDEGUARD months Sideguard TRYTON 1 6 months Tryton BIPAX 9 months Nile Pax For descriptive purposes only - Clinical trials with different protocols should not be compared. Dedicated self-expanding platform Dedicated bifurcation stent Self-expanding nitinol stent that conforms to the specific bifurcation anatomy Excellent wall apposition Spans both vessels at the same time No false carina Does not cover the flow divider even in a full bifurcation reconstruction
4 Very low definite VLST not resulting in any death 1 Only one definite VLST attributed to the Axxess stent whereas all events occured in relation to Cypher stents Definite stent thrombosis at 3 years 1,3 4 Cumulative incidence (%) 2.4% 3 1.7% 2 1.3% Months of follow-up n=302 Abluminal * biodegradable coating No drug carrier or drug inside the stent leads to: Early BMS-like endothelial coverage 8 More targeted drug release Reduced systemic exposure BA9 drug 10 times more lipophilic than Sirolimus % Sirolimus Zotarolimus Everolimus Biolimus A9 Highest lipophilicity of the common limus drugs 8 Minimizes systemic exposure and reduces the drug circulating in the bloodstream Due to high lipophilicity, the drug is rapidly absorbed by tissue Conical shape Two models Reference vessel diameter 3.0 ± 0.25 mm Max. proximal stent diameter = 3.75 mm Max. distal stent diameter = 6.00 mm Reference vessel diameter 3.5 ± 0.25 mm Max. proximal stent diameter = 4.25 mm Max. distal stent diameter = 6.50 mm Maximum diameter without constraint
5 Clinical Program AXXESS FRANCE, GERMANY n= 43 6-month follow-up available Study completed Pilot study using bare metal stent Axxess TM platform In-segment restenosis at 6 months AXXESS PLUS EUROPE, BRAZIL, NEW ZEALAND To evaluate the acute and long term safety and performance of the Axxess TM DES DIVERGE EUROPE, AUSTRALIA, NEW ZEALAND To evaluate the safety and performance of the Axxess TM DES for the treatment of de novo bifurcation lesions n= year follow-up available Study completed Main vessel in-stent late loss at 6 months n= 302 MACE (Death, MI and id-tlr) at 9 months 3-year follow-up available Follow-up planned up to 5 years AXXENT EUROPE n= month follow-up available Study completed Pilot study for Axxess TM Left Main DES 9 MACE (Death, MI or CABG/PCI TLR) at 6 months
6 Ordering Information Reference vessel diameter (±0.25 mm) 11 mm Stent length 14 mm 3.0 mm AXBF-3011 AXBF mm AXBF-3511 AXBF-3514 * The coating is applied primarily on the abluminal surface 1. Agostoni, P., oral presentation, EuroPCR Verheye, S. et al., 9-Month Clinical, Angiographic, and Intravascular Ultrasound Results of a Prospective Evaluation of the Axxess Self-Expanding Biolimus A9-Eluting Stent in Coronary Bifurcation Lesions. The DIVERGE (Drug-Eluting Stent Intervention for Treating Side Branches Effectively) Study, J Am Coll Cardio 2009;53: Definite stent thrombosis defined by ARC (Cutlip et al,. Circulation, 2007). Differs from protocol definition 4. Verheye, S., oral presentation, TCT Latib, A. et al., The Cappella Sideguard stent, EuroIntervention Volume 6 Supplement J - FEB Coronary bifurcation Stenting 6. Magro, M. et al., The Tryton Side Branch stent, EuroIntervention Volume 6 Supplement J - FEB Coronary bifurcation Stenting 7. Garcia, B., oral presentation, EuroPCR Data on file at Biosensors Intl 9. Left main stent is not CE approved Axxess Drug Eluting Coronary Bifurcation Stent System is CE approved. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Axxess, Biolimus A9 and BA9 are trademarks or registered trademarks of Biosensors International Group, Ltd. All cited trademarks are the property of their respective owners. Not available for sale in the United States and certain other countries Biosensors International Group, Ltd. All rights reserved. BIOSENSORS EUROPE SA Rue de Lausanne Morges Switzerland Tel: +41 (0) Fax: +41 (0) BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD Blk 10 Kaki Bukit Avenue 1 #06-01/04 Singapore Tel: Fax: EN Rev.02
Tailored bifurcation therapy
Tailored bifurcation therapy Dedicated self-expanding platform that conforms to the specific bifurcation anatomy Full bifurcation lesion coverage without creating a false carina Bifurcation DES technology
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