Introduction

2. Introduction • Drug-eluting stents have defined a new era in the successful treatment of coronary artery disease • However, like any therapy, DES results are not always what are predicted or expected, stent placement alone does not guarantee the best outcome • Unless the stent is optimally deployed with full lesion coverage, full expansion and good apposition to the vessel wall, there remains a risk of complications such as late stent thrombosis

3. Introduction • Such complications can compromise the benefits of the intervention and add to the cost of treatment • Lesion preparation in general and pre-dilatation in particular can optimize stent deployment to better achieve the full benefits of DES therapy • Optimal deployment assurance is vital to ensure good stent apposition and uniform absorption of the drug within the treated lesion Pre-dilatation may help reduce stent malapposition & late stent thrombosis

4. Powerline™ PTCA Dilatation catheterMessaging Take the fast track to superior patient outcomes • Messaging: • The Powerline™ PTCA dilatation catheter is a high performance pre-dilatation workhorse balloon catheter designed to prepare the lesion for optimal DES placement, even in complex anatomy • Powerline’s advanced catheter technology offers the right balance of PUSH, TRACK and CROSS to ensure optimal balloon placement and expansion

5. Importance of pre-dilatation • Pre-dilatation is not a matter of evidence based medicine • What clinical data tells us: • Previous studies reveal that direct stenting, as compared to pre-dilatation, has similar feasibility, efficacy and safety outcomes • However, most of these studies have been performed only in the pre-DES era and in very selected patients with non-complex lesions • Today >50% of case involve B2/C lesions • On the other hand, pre-dilatation reduces costs, fluoroscopic exposure, procedural time and contrast use • Not evidence based medicine, but experience and current practice have a real value Swibap study, H Le Breton et Al., Am J Cardiol 2001 Mehilli et al, Catheter Cardiovasc Interv. 2004 Suselbeck et al, Int J Cardiol 2005 Trends study, KD Dawkins et Al., Am J Cardiol 2006

6. Importance of pre-dilatation • Main risks of direct stenting: • Inability to dilate the stent in heavily calcified or fibrotic lesions, which may lead to serious complications, i.e. surgery • Incomplete stent deployment • In-accurate stent placement • Loss of guidewire and/or guiding catheter engagement due to insufficient support • Stent shift due to watermelon seeding • Stent dislodgement • DES polymer damage Stent malapposition is a main predictor of late stent thrombosis • Coronary angiogram showing complete occlusion in the proximal left anterior descending artery segment, where a stent had been placed • (C) Intravascular sonography shows the presence of gaps between stent struts (white arrowhead) and the vessel wall (black arrowhead). Heart. 2004 May; 90(5): e26. doi: 10.1136/hrt.2003.031419

7. Importance of pre-dilatation • Pre-dilatation optimizes stent outcomes and may • Assure optimal stent placement • Identify un-dilatable lesions prior to stenting, hence avoiding serious complications • Create a pathway for the stent • Provide understanding of lesion length, diameter, and morphology • Help to avoid complications with potential stent gaps or geographic misses • Prevent damage to the drug coating during delivery • Reduce plaque shift • Reduce need for high pressure stent implantation • Preserve sidebranchesin bifurcations • Reduce economic risk of improper DES selection Pre-dilatation may reduce stent malapposition & late stent thrombosis

8. Powerline™: Push - Track - Cross– achieving the right balance to meet the clinical need Powerline’s advanced catheter technology offers the right balance of PUSH, TRACK and CROSS, designed to ensure optimal balloon placement and expansion

9. Powerline™: Push - Track - Cross– achieving the right balance to meet the clinical need Pushability • 1.9 F PTFe coated hypotube • Power stylet Trackability • Slip-X™ hydrophilic coating • Flexible distal shaft Crossability • Low profile tip with smooth diameter transition to balloon • MultiPleat folding technology

10. Excellent Pushability • The PTFE-coated hypotube in combination with the power stylet transition in the middle shaft provides the right balance between pushability and trackability offering a smoother force transmission from the proximal to distal portion of the catheter shaft.

11. Excellent Trackability • The combination of the Slip-X™ hydrophilic coating and the flexible distal shaft ensure outstanding trackability and crossability for complex lesions or tortuous anatomy

12. Excellent Crossability • The flexible low profile tip section with smooth transitions and short bonding offers a gradual increase towards the balloon to facilitate lesion entry. • Powerline’s advanced MultiPleat folding technology is designed to offer exceptional lesion crossability and uniform balloon expansion as well as excellent balloon re-wrap and re-cross properties for treating challenging lesions.

13. Specifications

14. Powerline™ product schematic A D B C Flexible tip section with smooth transistions and short bonding to increase flexibility gradually Semi-compliant Pebax balloon material combined with Slip-X™ hydrophilic coating with for enhanced crossability Power stylet transition in the middle shaft provides a smoother force transmission from the proximal to distal shaft PTFE coated 1.9F hypotube for improved pushability

15. Powerline™ Balloon Markers • Balloons Markers • The distance between the markerbands (Outside to outside) will be equal to the advertised balloon working length • The outside edges of the markerbands will match the edges of the balloon working length at nominal pressure

16. Powerline™ Guide Catheter Compatibility • Powerline is compatible with 5F (min I.D. 0.055” / 0.139 mm) • 2 balloons for kissing balloon technique 3.0/20mm (or smaller ) can be used simultaneously within a guide catheter of 6F (I.D. 0.064” )

17. Balloon folds All balloons are machine fold to ensure a consistent and re-producable primary profile as well as a low secondary profile for complex cases 2-fold 3-fold 4-fold

18. Broad range of sizes

19. Compliance data * Nominal pressure ** Rated Burst Pressure

20. Powerline Excellent cross and re-cross properties • The advanced MultiPleat folding technology provides a low crossing profile for excellent lesion crossability and uniform balloon expansion. • It also provides an excellent balloon rewrap for low secondary profiles 2.0-3.0mm 3-fold 1.5mm 2 folds 3.5-4.0mm 4-fold

21. Powerline™ and BioMatrix™ – designed to optimize your DES outcomes The combination of Powerline’s advanced catheter technology to pre-dilate the lesion and the BioMatrix drug-eluting coronary stent system, developed for improved healing and long-term safety, are designed to optimize your DES patient outcomes. BioMatrix offers the unique combination of a proprietary anti-restenotic drug, Biolimus A9™, a biodegradable poly-lactic acid polymer (PLA), and an advanced, highly flexible stent designed for enhanced deliverability.