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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

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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

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Powerline™ PTCA Dilatation catheterMessaging

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

Take the fast track to superior patient outcomes

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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 2001Mehilli et al, Catheter Cardiovasc Interv. 2004Suselbeck et al, Int J Cardiol 2005Trends study, KD Dawkins et Al., Am J Cardiol 2006

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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

(A) 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

Stent malapposition is a main predictor of late stent thrombosis

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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 sidebranches in bifurcations

• Reduce economic risk of improper DES selection

Pre-dilatation may reduce stent malapposition & late stent thrombosis

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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

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Powerline™: Push - Track - Cross– achieving the right balance to meet the clinical need

• 1.9 F PTFe coated hypotube

• Power stylet

Pushability

Trackability

Crossability

• Slip-X™ hydrophilic coating

• Flexible distal shaft

• Low profile tip with smooth diameter transition to balloon

• MultiPleat folding technology

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• 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.

Excellent Pushability

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

Excellent Trackability

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• 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.

Excellent Crossability

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Specifications

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Powerline™ product schematic

A. Flexible tip section with smooth transistions and short bonding to increase flexibility gradually

B. Semi-compliant Pebax balloon material combined with Slip-X™ hydrophilic coating with for enhanced crossability

C. Power stylet transition in the middle shaft provides a smoother force transmission from the proximal to distal shaft

D. PTFE coated 1.9F hypotube for improved pushability

A B C D

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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

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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” )

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Balloon folds

4-fold

2-fold

3-fold

All balloons are machine fold to ensure a consistent and re-producable primary profile as well as a low secondary profile for complex cases

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Broad range of sizes

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Compliance data

* Nominal pressure** Rated Burst Pressure

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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

3.5-4.0mm 4-fold2.0-3.0mm 3-fold1.5mm 2 folds

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The combination of Powerline’s advanced catheter technology to pre-dilate thelesion and the BioMatrix drug-eluting coronary stent system, developed for improvedhealing 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.

Powerline™ and BioMatrix™ – designed to optimize your DES outcomes