EP SALES TRAINING Blazer II XP™ Ablation Catheter.

EP SALES TRAINING

Blazer II XP™ Ablation Catheter

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Blazer II XP™ Ablation CatheterAgenda

Blazer II XP™- Features Atrial Flutter Positioning Brochure Competition Cabling Chart Evaluation Model How to Use Generators Troubleshooting Guide Clinical Evidence Conclusion


Blazer II XP™ Ablation CatheterFeatures

Handle• Tension Control•Bi-wing Steering•Handle Ergonomics

Proximal Shaft•Torqueability•Pushability •Trackability

Tip Electrode•Tip Size•Cooling•Temperature Sensor

Distal Segment• Length & Curve Shape• Performance• Active Steering


Blazer II XP™ & Blazer II XP™ HTD Feature Summary

Blazer II™Blazer II™

HTDBlazer II XP™

Blazer II XP™ HTD

Chilli II™

Standard Medium

Extended

Standard Torque ------ ------ ------High Torque ------

Small ------ ------ ------ ------Standard

Large Asymmetric

Passive Active ------ ------ ------ ------

7f/4mm ------ ------ 8f/8mm Str ------ ------ ------8f/8mm VM ------ ------ ------ ------

Exposed Imbedded ------ ------ ------ ------

Thermistor Thermocouple ------ ------ ------ ------

Cooling

Tip Electrode

Temperature Sensor

CATHETER FAMILY CONFIGURATIONSDISTAL SHAFT

CHARACTERISTICS

Tubing Lengths

Tubing Firmness

Curve Shapes


Blazer II XP™ Ablation Catheter Atrial Flutter

Anatomy & Conduction• Right Atrial Conduction

– Travels from SA node to the AVNODE

• Flutter– A re-entry circuit– Classified as Typicial or Atypical

• Typical is circuit around right atrium traveling counterclockwise and is CTI dependent.

– Other forms include scar re-entry, TV dependent, and LV dependent.

• Right Atrial Typical Flutter• Ventricular response is slower due

to the AV node blocking some of the circuits (i.e. 3:1)

• “Saw tooth” pattern on 12-lead



Ablating Flutter• Dx placed in CS and around RA

– CS = to pace medially and determine if origin is left or right

• Decapolar– Around RA = confirm circuit is

counterclockwise• Halo & Duo-Deca catheters

• Rx placed at TV– Linear lesion from TV to IVC

through the Eustachian ridge– Eustachian ridge very thick

requires deep lesion– Rx typically used to confirm bi-

directional block on either side of ablation line.

• Halo or Duo-Deca does the same thing.



Summary• Symptoms

– Palpitations– Dizziness– Short of Breath

• Rhythm– Narrow QRS– Variable conduction between the atrium and ventricle– Atrial cycle length of 200 - 250 msecs– Typical = counter clockwise around the right atrium

• Paroxysmal– Initiates and terminates spontaneously

• Ablation– Line from the TV to the IVC through the Eustachian

ridge– Bi-directional block along with cycle lengths confirms

success


Blazer II XP™ Ablation Catheter Positioning

DISEASE CATHETERAVNRT Blazer II

FLUTTER Blazer XPAFIB CHILLI II

FLUTTERCLINICAL REQUIREMENTS CATHETER FEATURES

Deep lesion due to thick tissues in the RA between the IVC and TV (Eustachian Ridge)

8f, 8mm --- 8f for RF heating area and 8mm for passive cooling for higher power levels

Micromovement to create linear lesion from TV to IVC Bi-Wing Steering Knob and Mechanical Steering Mechanism

Stable tip contact throughout linear lesion HTD Distal + Proximal tubing

Reach the TV Normal Sized Hearts = Large Curve and for Enlarged Hearts = Large Curve + Sheath (5890ST)


Blazer II XP™ Ablation Catheter Brochure

ClinicalBenefits

TechnicalInfo

OrderingInfo

POSITIONINGPOSITIONING


Blazer II XP™ Ablation Catheter Brochure


Blazer II XP™ Ablation Catheter Competition

COMPETITOR PRODUCT BSC SOLUTION

BARD Stinger™ 8mm Blazer II XP™Scorpion™ Blazer II XP™

St Jude Medical / IBI Therapy™ 8mm Blazer II XP™Livewire TC™ 8mm Blazer II XP™Safire™ Blazer II XP™Triflex™ ─────

Biosense Webster Celsius™ 8mm Blazer II XP™Johnson & Johnson

Medtronic ContactR™ 8mm Blazer II XP™ConductR™ 8mm Blazer II XP™


Blazer II XP™ Ablation Catheter Cabling Chart

Catheter can be connected to: ▪ EPT 1000XP™ generator▪ Maestro 3000™ generator▪ Stockert generator▪ Osypka generator▪ IBI generator (not in the chart, model number 1684-THitem 85864)

Blazer II XP™ (thermistor sensor)cannot be used with Medtronicgenerator ATAKR™.


Blazer II XP™ Ablation Catheter Evaluation Model

When preparing the evaluation of new customer please follow the SIX easy steps outlined below:

STEP 1:

Schedule minimum 2 Flutter cases during the same day for the evaluation.

STEP 2:

The evaluation is to be performed with Maestro 3000™

generator.


STEP 3:

Suggest to the Physician to use high torque distal segment for the superior performance. Depending on the physician also mention we offer a standard torque distal segment which is less traumatic




STEP 4:

Suggest to Physician to use the Large Curve with a high torque tubing, for added performance. If Physician is accustomed to using a sheath, comment HTD should eliminate this need but order a 5890ST just in case.

LARGE HEARTalmost 80% of FLUTTER


STEP 5:

Utilize the following chart of part numbers to identify ALL of the components that you should order for the evaluation. DO NOT FORGET TO SCHEDULE 2 FLUTTER CASES!


Product Units Catheter Units Cable

3M004 EPT4500THK2 0

3 M004 651 0

M004 EPT4500TH 0

M004 651 0

M004 5890ST 0

1 M004 21000TC 0 2 M004 3536010 20

1 M004 21870T 0 5 M004 354 0

2 M004 653S 0

2 M004 613 0

1 ESI cable (42-04322)

1 ESI cable (42-04323)

2ESI filter box # 75-04452-001 before pod

MAESTRO

FLUTTER EVALUATION CATHETER CHECKLIST

BLAZER XP

Soft Tip Sheath

Connect BSC to NAVx


STEP 6: Before doing the ablation make the test on Maestro 3000™ - as described in the following slide.The test must be done in order to verify the compatibility of the generator with the recording system installed in the cat lab.

Tester required.





General Settings for FLUTTER:

Blazer II XP™ Ablation Catheter How to Use

Fluro6 o’clock on LAO viewECG keysBidirectional isthmus block

Power Temperature Time Impedance 65-70w 65-75°C 120 sec

- Stop based on ECG evaluation - Drag lesions will need multiple ON/OFF

Max 120ohm


Ablation ProblemHigh impedance: • Char or coagulum on the catheter tip: wipe catheter• Poor contact: need better reposition for better tip contact

Measured temperature BELOW Set Temperature • Verify power settings• Verify tip contact and measured impedance value• Verify cable connections are not loose or faulty

Measured temperature ABOVE Set Temperature• Transient measured above is acceptable• Verify no coagulum• Verify power settings• Verify cable connections are not loose or faulty• Turn OFF/ON generator to verify proper function



Ablation ProblemMeasured Power BELOW Set Power• Verify power and temperature settings• Verify cable connections are not loose or faulty

Noisy Signals during ablation• Verify amplification, clipping and filtering parameters of recording

machine are properly set.• Verify cable connections are not loose or faulty• Verify generator on separate electric circuit from recording machine• Disconnect and turn off non-essential equipment.• Verify tip electrode is clean.• Consider changing APM or POD



11 error codes exist. Here listed meaning & solution.Brochure available.

Maestro 3000™Troubleshooting Guide


Blazer II XP™ - Clinical study for FDA approval

“Radiofrequency catheter ablation of type 1 atrial flutter using large-tip 8- or 10-mm electrode catheters and a high-output radiofrequency energy generator: results of a multicenter safety and efficacy study.”

Feld G, et Al.UCSD Medical Center, University of California, San Diego, USA.

Blazer II XP™ (8mm and 10mm) was used in order to determine the safety and efficacy in the treatment of atrial flutter.

Blazer II XP™ Ablation Catheter Clinical Evidence


Blazer II XP™ - Clinical study for FDA approval


250th patient enrolled21 active sitesMax number of cases per site 30

TechniqueSuccess Rates:

Acute: 94%Recurrence rate (6 months): 4%

Adverse Event RatesMajor: 8%

Product Usage (n=284) Curve Usage (n=219) 8mm straight: 40% 10mm straight: 50% 8mm contour: 10%

Asymmetrical (N4): 10% Large (K2): 70% Standard: 20%


FLUTTER Publications:

“Effect of isthmus anatomy and ablation catheter on radiofrequency catheter ablation of the cavotricuspid isthmus.”Da Costa A, et Al.University Hospital Jean Monnet, Saint-Etienne, France.

Circulation. 2004 Aug 31;110(9):1030-5.


PRODUCT Blazer I I XP™ 8mm tip SUCCESS RATES 97% NUMBER OF PATIENTS 123



“Use of different catheter ablation technologies for treatment of typical atrial flutter: acute results and long-term follow-up.”Marrouche NF, et Al.Cleveland Clinic Foundation,Cleveland,USA.

Pacing Clin Electrophysiol. 2003 Mar;26(3):743-6.


PRODUCT Biosense-Webster 8-mm-tip Blazer I I XP™ 10-mm tip

SUCCESS RATES 100% NUMBER OF PATIENTS 25



“Prospective randomized comparison of closed cooled-tip versus 8-mm-tip catheters for radiofrequency ablation of typical atrial flutter.”Schreieck J, et Al.Deutsches Herzzentrum Munchen and 1. Medizinische Klinik, Munich, Germany.

Cardiovasc Electrophysiol. 2002 Oct;13(10):980-5





Is 8-mm more effective than 4-mm tip electrode catheter for ablation of typical atrial flutter?Tsai, et Al.National Yang-Ming University, School of Medicine, and Veterans General Hospital-Taipei, Taiwan.

Circulation. 1999 Aug 17;100(7):768-71.




Blazer II XP™ Ablation CatheterConclusion

Blazer II XPBlazer II XPPositioningPositioning

Flutter

ClinicalClinicalNeedsNeeds

•Deep Lesion

•Linear Ablation

•Tip Contact

•Reach Anatomy

CustomerCustomerEvaluationEvaluation

•Min 2 AFL Cases•BSC Generator•Straight or VM Tip?•STD or HT Distal?•K2 or STD Curve?•Order per List

CatheterCatheterFeaturesFeatures

•8f/8mm Tip Electrode•Bi-wing knob and mechanical steering•HT distal and proximal tubings•Large Curve

EP SALES TRAINING Blazer II XP™ Ablation Catheter.

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