a stenting solution for below the kneea stenting solution for below the knee

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When stenting is the solution,BioMatrix FlexTM BTK offers...

Improving quality of lifeմեe benefits of invasive treatmentwere demonstrated despite the use of current conservative management,including structured training advice and a vasoactive drug (cilostazol) with established effects on both health-related quality of life and walking function in claudicants”Dr Joakim Nordanstig Principle Investigator IRONIC Trial - Sahlgrenska Univeristy Hospital, Gothenburg, Sweden

Stent Diameter (mm) 8 11 14 18 24 28 33 36

Stent Length (mm)

2.25 BMXBTK-2208 BMXBTK-2211 BMXBTK-2214 BMXBTK-2218 BMXBTK-2224 BMXBTK-2228 - -

2.50 BMXBTK-2508 BMXBTK-2511 BMXBTK-2514 BMXBTK-2518 BMXBTK-2524 BMXBTK-2528 BMXBTK-2533 BMXBTK-2536

2.75 BMXBTK-2708 BMXBTK-2711 BMXBTK-2714 BMXBTK-2718 BMXBTK-2724 BMXBTK-2728 BMXBTK-2733 BMXBTK-2736

3.00 BMXBTK-3008 BMXBTK-3011 BMXBTK-3014 BMXBTK-3018 BMXBTK-3024 BMXBTK-3028 BMXBTK-3033 BMXBTK-3036

3.50 BMXBTK-3508 BMXBTK-3511 BMXBTK-3514 BMXBTK-3518 BMXBTK-3524 BMXBTK-3528 BMXBTK-3533 BMXBTK-3536

4.00 BMXBTK-4008 BMXBTK-4011 BMXBTK-4014 BMXBTK-4018 BMXBTK-4024 BMXBTK-4028 - -

BioMatrix FlexTM BTK stent is CE Mark approved.

CAUTION: մեe law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions foruse can be found in the product labeling supplied with each device.

BioMatrix Flex BTK, Biolimus A9, BA9 and Quadrature Link are trademarks or registered trademarks of Biosensors International Group, Ltd.All cited trademarks are the property of their respective owners.

Les informations relatives à ce produit ne sont pas destinées aux professionnels de santé exerçant en FranceAny information related to this product is not intended for health care professionals who practice in France.

Not available for sale in the United States and certain other countries.© 2015 Biosensors International Group, Ltd. All rights reserved.

* In vivo testing in porcine model demonstrates abluminal coating is absorbed after 6 to 9 months – Data on file at Biosensors International.1. Data on file at Biosensors International.2. Eugenio Stabile MD, PHD, FESC Clinica Montevergine, Mercogliano, Italy. Oral presentation at TCT 2012.

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BIOSENSORS EUROPE SA

Rue de Lausanne 291110 MorgesSwitzerlandTel: +41 (0)21 804 80 00Fax: +41 (0)21 804 80 01

BIOSENSORS INTERVENTIONALTECHNOLOGIES PTE LTD

36 Jalan TukangSingapore 619 266Tel: +65 6213 5777Fax: +65 6213 5737

A proven safe and effective stent platform

BA9 biodegradable polymer technology – unparalleled clinical experience

Easy deliverability with excellent crossability, trackability and pushability

An extensive range of diameters and lengths

> Primary Endpoint was freedom from angiographic in-stent stenosis in excess of 50%> Secondary endpoints were death, cardiovascular mortality, clinical & hemodynamic success

Key results:> Robust improvement evident in CLI ptients> Low late lumen loss and minimum ISRS rate> No major or minor amputation

Setting the bar

Saving life, limbs and improving quality of life

At the heart of the matter

Abluminal biodegradable coating> No drug carrier or drug inside the stent > Early BMS-like endothelial coverage1

> More targeted drug release> Reduced systemic exposure

Delivery system:> Expandable peripheral 316L stainless steel stent> Semi-compliant rapid exchange balloon> Usable shaft length - 142 cm ± 3 cm> Shaft markers placement: 90 cm ±2 cm and 100 cm ±2 cm from tip> Balloon material: Polyamide elastomer (Pebax) 72D

DAPT 24 months

ANTI-COAGULANT

0% 25% 50% 75% 100%Procedural results

BA9 drug 10 times more lipophilic than Sirolimus1

Building the case2

Stentplatform

Biodegradablepolymer

Biolimus A9drug

Today, endovascular recanalization of stenotic or occluded infrapopliteal arteries represents an effective form of therapy. However, the occurrence of restenosis can negatively affect long-term patency rates.

Could drug-eluting stents developed for coronary arteries be an effective answer? Biosensors International is a leading cardiovasculardevice manufacturer with world-class technologies backed by outstanding clinical trial results in coronary vessels. With the introduction of BioMatrix FlexTM BTK (Below the Knee), peripheral recanalization can now benefit from the highest coronary standard of stenting.

BioMatrix Flex BTK combines an advanced stent platform which offers improved trackability and flexibility thanks to its Quadrature link™ design and the proven efficacy of Biosensors’ proprietary limus drug; Biolimus A9™, specifically developed for stent application.

Over 24 months, 25 patients with lower limb ischemia were implanted with a BioMatrix Flex stent. All patients received aspirin and either ticlopidine for a minimum of 7 days before the procedure, or a pre-load of clopidogrel 24 hours before the procedure.Post procedure, thyenopiridines were continued for 6 months and aspirin for life.

Controlateral access 1006F long sheath 96Lesion predilatation 14Concomitant Ileofemoral PTA 40DAPT 100Tibioperoneal trunk 48Tibial arteries 52Procedural success 100

Clopidogrel 300 mg loading doseor Aspirin 75-160 mg/dayand Ticlopidine 250 mg twice/day

UFH 10-199 UI/kg to achieve ACT>250s

Proven efficacy of the Biolimus A9 drugմեe highly lipophilic BA9 - over 10 times the other limus drug standard - is applied solely on the abluminal surface resulting in the drug being delivered at the exact location of the lesion.

PLA biodegradationand BA9 drug elution

Highest lipophilicity of the common limus drug 1

> Minimizes systemic exposure and reduces the drug circulating in the bloodstream

> Due to high lipophilicity, the drug is rapidly absorbed by tissue

մեe polymer biodegrades after 6 to 9 months, leaving only the bare metal stent in the vessel wall

BioMatrix Flex BTKTM drug-eluting stent

Quadrature linkTM design of stentprovides improved deliverability whilepreserving stent security andvessel scaffolding

BA9TM elution and PLA degradation

Abluminal coatingabsorbedafter 6-9 months*

Sirolimus Zotarolimus Everolimus Biolimus A9

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MortalityCardiovascular mortalityClinical successHemodynamic successMajor amputationsMinor amputations

Introducing a new effective approach

Procedural Data %