Extend your Senses

For over 20 years, Biosense Webster has pioneered the development of Atrial Fibrillation Ablation treatment.

ATRIAL FIBRILLATION

PROGRESSIVE DISEASE

#1 CAUSE OF SUDDEN CARDIAC DEATH6

NEW MILLENNIUM EPIDEMIC1

VENTRICULAR TACHYCARDIA

1,2,3

Atrial Fibrillation Ablation - Outcome at

12 months follow-up

up to 92%12,13

66%10

2016

1998

CARTO SMARTTOUCHTM Technology withAblation Index

>80%11

2014

THERMOCOOL SMARTTOUCH®

Catheter

NAVISTAR™

THERMOCOOL Catheter

of patients with VT are HOSPITALIZED for cardiac-related events over a period of 6 months7

80%Nearly

47%Up to

REDUCTION in cardiac-related hospital admissions after RF ablation8,9

1 IN 42

LIFETIME RISK OF HAVING AF

PAROXYSMAL PERSISTENT AF

ONE YEAR4,5

Automatization of activation and

voltage mapping with the PENTARAYTM

Catheter

Uniform Coolingat half the flow rate

Prediction of lesionformation by integratingpower, force and timein a single value whenthe catheter is stable

2012

CONFIDENSE™Module

2014

2011THERMOCOOLSMARTTOUCH®

Catheter

Contact forcevector information

CARTOUNIVUTM

Module

2015THERMOCOOL

SMARTTOUCH® SF Catheter

2016CARTO VISITAG®

Module with Ablation Index

2018HD Coloring

PENTARAY NAVTM

Catheter

Seamless combination of fluoroscopy on the CARTO® 3 System in a single view

46% higher resolution in

LAT and voltage mapping

2019CARTO VIZIGO™

Sheath

Integrating real-time steerable sheath

visualization to your CARTO® System

experience

RIGHT FIRST TIME with

48%NOT WELL MANAGED with antiarrhythmic drugs alone and considered to be eligible for ablation3

of patients are

The CARTO VISITAG® Module provides access to data collected during the application of RF energy. The data does not indicate the effectiveness of RF energy application. CARTO VISITAG® Module settings are user defined based on the user's clinical experience and medical judgment. Biosense Webster does not recommend any settings for the CARTO VISITAG® Module.

RIGHT FIRST TIMEDURABLE PULMONARY VEIN ISOLATION12,13

PAROXYSMAL ATRIAL FIBRILLATION

* Assumes base lab cost per minute=7.41€21 Catheter costs per procedure=€2700 Average procedure time=120min

Considers 100 patients per year.Based on the publication from Philips, T. et al where single-procedure freedom from atrial tachycardia was 94% with Ablation Index vs. 80% with contact force.20

The cost of the procedure is an estimation and may vary depending on procedural time, personnel, material costs and other resources used. Procedural effectiveness and efficiency (mapping time, procedure time, fluoro time, success rate) may vary by patients and operators.

Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® 3 System User Guide regarding recommendations for fluoroscopy use.Pellegrino, P.L., Brunetti, N.D., Gravina, D., Sacchetta, D., De Sanctis, V., Panigada, S., Di Biase, L., Di Biase, M., and Mantica, M. (2013). Nonfluoroscopic mapping reduces radiation exposure in ablation of atrial fibrillation. Journal of cardiovascular medicine 14, 528-533. Earley, M.J., Showkathali, R., Alzetani, M., Kistler, P.M., Gupta, D., Abrams, D.J., Horrocks, J.A., Harris, S.J., Sporton, S.C., and Schilling, R.J. (2006). Radiofrequency ablation of arrhythmias guided by non-fluoroscopic catheter location: a prospective randomized trial. Eur Heart J 27, 1223-1229.

compared to PVI with contact force (no CARTO VISITAG® Module with Ablation Index)

SIMPLIFICATION

procedural time20 RF time20

-22% -36%

...in different centers12,13,18,19 THERMOCOOL SMARTTOUCH®

Catheter

THERMOCOOL SMARTTOUCH®

CatheterTHERMOCOOL™

Catheter

THERMOCOOL SMARTTOUCH®

Catheter

Hussein 2017b

(N=174, p=0.0005 )

Cano 2015c

(N=44, p<0.001)

THERMOCOOL SMARTTOUCH®

Catheter & CARTOUNIVU™ Module

CARTOUNIVU™Module

...with different operators12,13,18,19

STANDARDIZATION REPRODUCIBILITY

UP TO 92% SUCCESS RATE AT 1 YEAR

FOLLOW-UP12,13,18,19

<2 HOURS PROCEDURE DURATION14-17

SINGLE PROCEDURE

SAFETY

of patients free of adverse events (n=1574)12,14,15,22,2399.4%

•PENTARAYTM Catheter has an unique design allowing multi-planar PVI validation vs the single plane of the LASSOTM Catheter

• of PV’s circular catheter can’t be positioned to confirm isolation293% • of patients with right middle veins3013%

• reduction in diameter after ablation due to edema (LIPV and RIPV diameter 15-16 mm)3111%

NEVER MISS A GAP

25%

Prospective controlled study of persistent AF patients

Prospective controlled study of AF patients

b

c

82%

-82% reduction in exposure to radiation27RISK OF RADIATION

EXPOSURE24-26

~1 in 100DEVELOP CANCER

>1/3MISSED WORK

•After circumferential PV ablation, veno-atrial conduction may still exist through direct fibers between LA and PV. This can only be detected with PVI validation.28

PENTARAYTM NAVCatheter

LASSO™NAVCatheter

potentially costs reduction by up to

SAVING

per year12,20*€70,000

CARTO VISITAG® Module

with Ablation Index

THERMOCOOL SMARTTOUCH® SF

Catheter

THERMOCOOL SMARTTOUCH®

Catheter

PERSISTENT ATRIAL FIBRILLATION RIGHT FIRST TIMESUPPORTING ON YOUR DECISION MAKING

THROUGH COMPLETE MAPPING SOLUTION

** Based on a meta-analysis of 19 studies that compared contact force catheters (all products) to non-contact force catheters (all products) in patients with AF.11

REDUCTION IN THE RATE OF MAJOR COMPLICATIONS WITH CONTACT FORCE TECHNOLOGY33

(vs non-CF)

€8,419FOR HEART FAILURE34

TOTAL PER PATIENT COST OF COMPLICATIONS MAY BE AS HIGH AS:

VS. THERMOCOOL SMARTTOUCH® Catheter while maintaining acute success35

52% LESS FLUID

(PVI performed with Ablation Index)

80%SUCCESS RATE AT1 YEAR FOLLOW-UP32

(with Ablation Index vs CF only)

+22%SUCCESS RATE22

Up to 42%**

AF PATIENTS WITH SCAR RELATED SUBSTRATE37-39, 41-47

PATIENTS WITH SUBSTRATE HAVE HIGHER RECURRENCE RATE AFTER CATHETER ABLATION37-42

35%-84%

HIGHER SUCCESS RATEat 1 year follow-up when PVI + ablation of scar related substrate performed42

43%UP TO

MAPPING TIME WITH THE PENTARAY™ CATHETER

(compared to mapping with THERMOCOOL SMARTTOUCH

®

Catheter or NAVISTAR™ RMT THERMOCOOL™ Catheter)48

-58%

THERMOCOOL SMARTTOUCH® SF

Catheter

CONFIDENSE™Module

PENTARAY™Catheter

THERMOCOOL SMARTTOUCH®

Catheter

CARTO VISITAG® Module

with Ablation Index

SIGNIFICANT REDUCTION WITH CARTO® 3 SYSTEM EVOLUTION

COMPLEX ATRIAL TACHYCARDIA VENTRICULAR TACHYCARDIA DURABLE PULMONARY VEIN ISOLATION12,13

SUPPORTING ON YOUR DECISION MAKING THROUGH COMPLETE MAPPING SOLUTION

* when mapping performed with the PENTARAYTM Catheter compared to mapping with THERMOCOOL SMARTTOUCH® Catheter or NAVISTAR™ RMT THERMOCOOL™ Catheter

┼ Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® 3 System User Guide regarding recommendations for fluoroscopy use.Pellegrino, P.L., Brunetti, N.D., Gravina, D., Sacchetta, D., De Sanctis, V., Panigada, S., Di Biase, L., Di Biase, M., and Mantica, M. (2013). Nonfluoroscopic mapping reduces radiation exposure in ablation of atrial fibrillation. Journal of cardiovascular medicine 14, 528-533. Earley, M.J., Showkathali, R., Alzetani, M., Kistler, P.M., Gupta, D., Abrams, D.J., Horrocks, J.A., Harris, S.J., Sporton, S.C., and Schilling, R.J. (2006). Radiofrequency ablation of arrhythmias guided by non-fluoroscopic catheter location: a prospective randomized trial. Eur Heart J 27, 1223-1229.

A retrospective study reported that the non-fluoroscopic CARTO® 3 System with progressively new technologies such as contact force provides an increasing and significant reduction in fluoroscopy time.51┼

MORE ABNORMAL POTENTIALS detected49

MAPPING TIME with the PENTARAYTM

Catheter48*

REDUCTION in VT recurrence with RF ablation compared to medical management at 14-month follow up50

-58%HIGHER SUCCESS RATE at 1 year follow-up48*

+20%

UP TO

29%

+250%

REDUCTION in radiofrequency time with the PENTARAYTM Catheter48*

-44%

SIMPLIFICATION

EFFICACY

CARTO® XPSystem

CARTO® 3System

CARTO® 3System CF

05

1015202530354045

Flu

oro

sco

py

Tim

e (m

in)

43±11

14±69±3

Atrial Fibrillation Ablation - Outcome at

12 months follow-up

Up to 92%12,13

2016

CARTO SMARTTOUCHTM Technology withAblation Index

>80%11

2014

THERMOCOOL SMARTTOUCH®

Catheter

66%10

1998

NAVISTAR™

THERMOCOOL Catheter

EFFICIENCY

EFFICACY

INNOVATION

CONFIDENSE™Module

PENTARAY™Catheter

THERMOCOOL SMARTTOUCH®

Catheter

THERMOCOOL SMARTTOUCH® SF

Catheter

RIGHT FIRST TIME with

1. Abed, H. S. and Wittert, G, A. (2013), Obesity and atrial fibrillation. Obes Rev, Clinical Electrophysiology, 14(11):929-382. Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D et al. (2004) Lifetime risk fr development of atrial fibrillation: the Framingham Heart Study. Circulation 110 (9): 1042-1046.3. Calkins H, Reynolds MR, Spector P, Sondhi M, Xu Y et al. (2009) Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systems literature reviews

and meta-analyses. Circ Arrhythm Electrophysiol 2 (4): 349-3614. Nieuwlaat R, Prins MH, Le Heuzey JY, Vardas PE, Aliot E et al. (2008) Prognosis, disease progression, and treatment or atrial fibrillation patients during 1 year: follow-up of the

Euro Heart Survey on atrial fibrillation. Eur Heart J 29 (9): 1181-1189.5. Schnabel R, Pecan L, Engler D, Lucerna M, Sellal JM et al. (2018) Atrial fibrillation patterns are associated with arrhythmia progression and clinical outcomes, Heart 6. Harris P LD (2016) Ventricular arrhythmias and sudden cardiac death. British Journal of Anesthesia Education 16 (7): 221-229.7. Marchlinski FE, Haffajee CI, Beshai JF, Dickfeld TL, Gonzalez MD et al. (2016) Long-Term Success of Irrigated Radiofrequency Catheter Ablation of Sustained Ventricular

Tachycardia: Post-Approval THERMOCOOL VT Trial. J Am Coll Cardiol 67 (6): 674-683.8. Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R et al. (2010) Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary

heart disease (VTACH): a multicentre randomised controlled trial. Lancet 375 (9708): 31-40.9. Winterfield JR, Kent AR, Karst E, Dalal N, Mahapatra S et al. (2017) Impact of ventricular tachycardia ablation on health care utilization. Heart Rhythm 15 (3): 355-362.10. Wilber, D. et al. (2010), Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation A Randomized Controlled

Trial. AMA. 11. Natale A, Reddy V, Monir G, et al. (2014), Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF Trial. J Am Coll

Cardiol 19;64(7):647-56. Success defined as freedom from any symptomatic atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) 12 months Post-procedure when operator remained in the preset contact force range. Further sub-analysis showed that when the contact force was within investigator-selected range ≥85% of time, success rate increased by 21% to 88% (≥85%: n=32; <85%: n =73)

12. Taghji P et al. (2018), Evaluation of a strategy aiming to enclose the pulmonary veins with contiguous and optimized radiofrequency lesions in paroxysmal atrial fibrillation. A pilot study.; JACC Clin Electrophysiol. 4(1):99-108

13. Solimene F, et al. (2019), Safety and efficacy of atrial fibrillation ablation guided by Ablation Index module. JCE 54(1):9-1514. Pontoppidan J, Sandgaard NCF, Riemann M, Djurhuus S, Dalhoej J et al. (2018) Introducing a rigorous atrial fibrillation ablation strategy with ablation index and point-by-point

ablation is feasible and safe. (#P909) EHRA EUROPACE - CARDIOSTIM 2017. Vienna, Italy.15. De Potter T, Hunter TD, Boo LM, Chatzikyriakou S, Strisciuglio T et al. (2017) Ablation Efficiency with Contact Force Stability and Ablation Index in Paroxysmal Atrial Fibrillation.

(#PO02-88) Heart Rhythm Society’s 38th Annual Scientific Sessions (HRS). Chicago, IL.16. Riemann M, Sandgaard NCF, Dalhoj J, Djurhuus S, Johansen JB et al. (2018) Ablation index in atrial fibrillation ablation, initial experience with a novel endpoint in point-by-point

ablation in pulmonary vein isolation. (#P914) EHRA EUROPACE - CARDIOSTIM 2017. Vienna, Italy.17. Weberndoerfer V, Toggweiler S, Schefer T, Russi I, Brinkert M et al. (2018) Early experience with ablation index-guided pulmonary vein isolation compared with force-time integral-

guided ablation using surround flow catheter tip irrigation for ablation of atrial fibrillation. (#1160) EHRA EUROPACE - CARDIOSTIM 2017. Vienna, Italy18. De Ruvo, et al. (2018), Impact of a novel lesion target on clinical outcome of paroxysmal atrial fibrillation ablation. Europace (20): i125–i126

19. Dello Russo, Casella, Natale, et al. (2017), Ablation Index: A Standardized Technique To Reach Higher AF Treatment Effectiveness In A Single-centre Experience. EP Europace (19): 1109–1115

20. Phlips, T. et al. (2018), Improving procedural and one-year outcome after contact force-guided pulmonary vein isolation: the role of interlesion distance, ablation index, and contact force variability in the ‘CLOSE’-protocol. Europace. 2018 Nov. Europace 20(FI_3):f419-f427

21. Klein, G., Lickfett, L., Schreieck, J. et al. (2015). Comparison of ‘anatomically designed’ and ‘point-by-point’catheter ablations for human atrial fibrillation in terms of procedure timing and costs in German hospitals. EP Europace, 17(7), 1030-1037. (adapted by inflation rate)

22. Hussein, A. et al. (2017), Prospective use of Ablation Index targets improves clinical outcomes following ablation for atrial fibrillation. J Cardiovasc Electrophysiol 2017 Sep;28(9):1037-1047.

23. Sultan, A. et al. (2017), The New Ablation Index: A Tool to Standardize and Facilitate Pulmonary Vein Isolation with Anatomical Encirclement. HRS (14): S177 (C-PO02-83)24. Heidbuchel, H. et al. (2014), European Heart Rhythm A: Practical ways to reduce radiation dose for patients and staff during device implantations and electrophysiological

procedures. Europace;16:946-96425. Gerber, TC. et al. (2009), MV: Ionizing radiation in cardiac imaging: A science advisory from the American Heart Association Committee on Cardiac Imaging of the Council on

Clinical Cardiology and Committee on Cardiovascular Imaging and Intervention of the Council on Cardiovascular Radiology and Intervention. Circulation;119:1056-106526. The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP 2007;37:1-33227. Cano, O. et al. (2015), Initial Experience with a New Image Integration Module Designed for Reducing Radiation Exposure During Electrophysiological Ablation Procedures.

JCE 26(6):662-7028. Cabrera, J. et al. (2009), Morphological evidence of muscular connections between contiguous pulmonary venous orifices: Relevance of the interpulmonary isthmus for catheter

ablation in atrial fibrillation. Heart Rhythm Society. 6(8):1192-829. Hsu, L. et al. (2005), High-Density Circumferential Pulmonary Vein Mapping with a 20-Pole Expandable Circular Mapping Catheter. Pacing Clin Electrophysiol. 28 Suppl 1:S94-8.30. Kiuchi, K. et al. (2015), Topographic variability of the left atrium and pulmonary veins assessed by3D-CTpredictstherecurrenceofatrial fibrillation after catheter ablation. Japanese

Heart Rhythm Society. 31(5):286-9231. Yamamoto, T. et al. (2014), Comparison of the change in the dimension of the pulmonary vein ostia immediately after pulmonary vein isolation for atrial fibrillation-open irrigated-tip

catheters versus non-irrigated conventional 4 mm-tip catheters. JCE. 41(1):83-9032. Hussein A, Riva S, Morgan M, et al. (2018), Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in

Persistent Atrial Fibrillation Patients. Circ Arrhythm Electrophysiol. 11(9):e006576.33. Zhou X, Lv W, Zhang W,Ye Y, Li Y et al. (2017) Impact of contact force technology on reducing the recurrence and major complications of atrial fibrillation ablation: A systematic

review and meta-analysis. Anatol J Cardiol 17 (2): 82-9134. Cotté FE, Chaize G, Gaudin AF, Samson A, Vainchtock A et al. (2015). Burden of stroke and other cardiovascular complications in patients with atrial fibrillation hospitalized in

France. Europace 18 (4): 501-50735. Chinitz LA, Melby DP, Marchlinski FE, Delaughter C, Fishel RS et al. (2017) Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal

atrial fibrillation ablation: results from the SMART SF trial Europace 2017 (0): 1–9.36. Malcolme-Lawes, L. et al. (2013), Automated analysis of atrial late gadolinium enhancement imaging that correlates with endocardial voltage and clinical outcomes: A 2-center

study. HRS. 10(8):1184-9137. Verma, A. et al. (2004), Pre-Existent Left Atrial Scarring in Patients Undergoing Pulmonary Vein Antrum Isolation. JACC. 18;45(2):285-9238. Yamaguchi, T. et al. (2016), Efficacy of Left Atrial Voltage-Based Catheter Ablation of Persistent Atrial Fibrillation. JCE. 27(9):1055-6339. Masuda, M. et al. (2015), Influence of underlying substrate on atrial tachyarrhythmias after pulmonary vein isolation. HRS. 13(4):870-840. Mahnkopf, C. et. al. (2010), Evaluation of the left atrial substrate in patients with lone atrial fibrillation using delayed-enhanced MRI: Implications for disease progression and

response to catheter ablation. HRS. 7(10):1475-8141. Oakes, R. et al. (2009), Detection and Quantification of Left Atrial Structural Remodeling With Delayed-Enhancement Magnetic Resonance Imaging in Patients With Atrial

Fibrillation. Circulation. 7;119(13):1758-6742. Rolf, S. et al. (2016), Tailored Atrial Substrate Modification Based on Low-Voltage Areas in Catheter Ablation of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 7(5):825-3343. Yang, G. et al. (2016), Catheter Ablation of Nonparoxysmal Atrial Fibrillation Using Electrophysiologically Guided Substrate Modification During Sinus Rhythm After Pulmonary Vein

Isolation. Circep. 9(2):e00338244. YYagishita, A. et al. (2016), Long-Term Outcome of Left Atrial Voltage-Guided Substrate Ablation During Atrial Fibrillation: A Novel Adjunctive Ablation Strategy. JCE. 28(2):147-15545. Kottkamp, H. et al. (2016), Box Isolation of Fibrotic Areas (BIFA): A Patient-Tailored Substrate Modification Approach for Ablation of Atrial Fibrillation. JCE. 27(1):22-3046. Kosiuk, J. et al. (2015), Prospective, multicenter validation of a clinical risk score for left atrial arrhythmogenic substrate based on voltage analysis: DR-FLASH score. HRS.

12(11):2207-1247. Huo, Y. et al. (2018), Prevalence and predictors of low voltage zones in the left atrium in patients with atrial fibrillation. Europace. 1;20(6):956-96248. Bun, S. et al. (2018), A comparison between multipolar mapping and conventional mapping of atrial tachycardias in the context of atrial fibrillation ablation. Elsevier Masson.

111(1):33-4049. Berte, B. et al. (2015), Impact of Electrode Type on Mapping of Scar-Related VT. Journal of Cardiovascular Electrophysiology. 26(11):1213-122350. Santangeli P, Muser D, Maeda S, Filtz A, Zado ES et al. (2016) Comparative effectiveness of antiarrhythmic drugs and catheter ablation for the prevention of recurrent ventricular

tachycardia in patients with implantable cardioverter-defibrillators: A systematic review and meta-analysis of randomized controlled trials. Heart Rhythm 13 (7): 1552-1559.51. De Ponti R (2015) Reduction of radiation exposure in catheter ablation of atrial fibrillation: Lesson learned. World J Cardiol 7 (8): 442-448.

Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.This publication is not intended for distribution outisde of the EMEA region. © Johnson & Johnson Medical NV/SA 2019. 109256-190211

EU Representative Biosense Webster, Inc. A Division of Johnson & Johnson Medical NV/SALeonardo da Vincilaan 15 | 1831 Diegem, Belgium Tel: +32-2-7463-401 | Fax: +32-2-7463-403 www.biosensewebster.com