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 catheter Messaging 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

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 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 (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 May; 90(5): e26. doi: /hrt Stent malapposition is a main predictor of late stent thrombosis

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 sidebranches in 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 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

10 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

11 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

12 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

13 Specifications

14 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 BC D

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 ” / mm) 2 balloons for kissing balloon technique 3.0/20mm (or smaller ) can be used simultaneously within a guide catheter of 6F (I.D ” )

17 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

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 mm 4-fold mm 3-fold 1.5mm 2 folds

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