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 Complete reconstruction possible
Proven safety of a dedicated bifurcation DES with an abluminal biodegradable polymer Safety and efficacy confirmed out to 4 years 1 Confirmed safety in DIVERGE The use of Axxess for the treatment of complex bifurcation lesions resulted in low 4-year event rates, with a MACE rate of 18.% % MACE defined as death, MI and id-tlr 2 15 1 Primary endpoint MACE at 9 months 2 7.7% 9.3% 14.% 16.% 18.% 5 n=32 1 2 3 4 Years Proven efficacy of the Biolimus A9 drug Very low restenosis rate in bifurcation lesions Restenosis in DIVERGE at 9 months 2,4 Proximal edge: 2.8% Axxess:.7% SB Cypher: 4.8% Low in-stent late loss (Axxess only) in DIVERGE at 9 months 2 :.18 mm Any in-segment bifurcation restenosis: 6.4% Distal PV Cypher: 2.1% 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
Very low definite VLST DIVERGE trial results 1 : Only one definite VLST attributed to Axxess ; all events occurred in relation to Cypher VLST did not result in any death No VLST events between years 3 and 4 Definite stent thrombosis at 4 years 1,3 4 3 2.% 2.% Abluminal * biodegradable coating % 2 1 1.% 1.3% No drug carrier or drug inside the stent: 1 2 3 4 n=32 Years Early BMS-like endothelial coverage 5 Targeted drug release Reduced systemic exposure BA9 drug 1 times more lipophilic than Sirolimus 5 1 8 % 6 4 2 Sirolimus Zotarolimus Everolimus Biolimus A9 Highest lipophilicity of the common limus drugs 5 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. ±.25 mm Max. proximal stent diameter = 3.75 mm Max. distal stent diameter = 6. mm Reference vessel diameter 3.5 ±.25 mm Max. proximal stent diameter = 4.25 mm Max. distal stent diameter = 6.5 mm Maximum diameter without constraint
Clinical Program AXXESS FRANCE, GERMANY n= 43 6-month follow-up completed Study completed Pilot study using bare metal stent Axxess 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 DES DIVERGE EUROPE, AUSTRALIA, NEW ZEALAND To evaluate the safety and performance of the Axxess DES for the treatment of de novo bifurcation lesions n= 139 5-year follow-up available Study completed Parent vessel and side branch in-stent late loss at 6 months measured by QCA n= 32 MACE (Death, MI and id-tlr) at 9 months 4-year follow-up available Follow-up planned up to 5 years AXXENT EUROPE n= 33 12-month follow-up available Study completed Pilot study for Axxess Left Main DES 6 MACE (Death, MI or CABG/PCI TLR) at 6 months COBRA EUROPE Randomized multicenter trial to compare Axxess DES along with BioMatrix with Cullotte technique using Xience V n= 4 Enrolling Stent strut coverage assessed by OCT at 9 months
Ordering Information Reference vessel diameter (±.25 mm) 11 mm Stent length 14 mm 3. mm AXBF-311 AXBF-314 3.5 mm AXBF-3511 AXBF-3514 * The coating is applied primarily on the abluminal surface 1. 4 - year clinical outcomes of dedicated bifurcation Axxess stent in DIVERGE trial, document 1159- at Biosensors Intl 2. 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 29;53:131 9 3. Definite stent thrombosis defined by ARC (Cutlip et al. Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions ). Circulation. 27; 115(17): 2344-51. Differs from protocol definition 4. Verheye S., Devax AXXESS Special Utility of Self Expanding Nitinol Stent For Bifurcation Lesions, oral presentation, TCT 29 5. Data on file at Biosensors Intl 6. 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. 212 Biosensors International Group, Ltd. All rights reserved. www.biosensors.com BIOSENSORS EUROPE SA Rue de Lausanne 29 111 Morges Switzerland Tel: +41 ()21 84 8 Fax: +41 ()21 84 8 1 BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD Blk 1 Kaki Bukit Avenue 1 #6-1/4 Singapore 417 942 Tel: +65 6213 5725 Fax: +65 6213 5737 1924--EN Rev.3