EP SALES TRAINING Blazer II™ Ablation Catheter. BSC Confidential – For Internal Use Only – Do...

EP SALES TRAINING

Blazer II™ Ablation Catheter

BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation CatheterAgenda

Blazer II™ & Blazer II HTD™- Features AVNRT Clinical Review Positioning Brochure Competition Cabling Chart Evaluation Model How to Use Generators Troubleshooting Guide Clinical Evidence Conclusion


Blazer II™ 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™ & Blazer II 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™ Ablation Catheter AVNRT

AV NODE• Regulates the conduction between the

Atrium and Ventricle• Composed of a fast and slow pathway• In a healthy heart, the fast and slow

pathway cancel each other depending on the bpm

AVNRT• Atrial Ventricular Nodal Re-entry

Tachycardia• PAC initiates a re-entry circuit in the

AV Node• Reentrant circuit around 50 msec• Stimulates both the A and V



Sinus Rhythm – slow pathway and fast pathway can not both be activated

AVNRT – a PAC comes in at a different time and is able to conduct through the slow pathway, up the fast pathway and start a reentry circuit



Mapping and Ablating AVNRT• Mapping usually done with three

fixed DX catheters (RA, His and RV)– Confirm AH jump between slow and

fast conduction

• Ablation of the slow pathway– posterior and anterior to the

AV node• Post ablation confirm no AH

jump



Summary• Symptoms

– Lightheadedness

– Rapid palpitations

– Pulsations in the neck

• Regular rhythm with narrow QRS– No visible P wave (may be buried at end of QRS)

– A and V stimulate simultaneously (reentry <50msecs)

– Ventricular rates between 160 – 200 bpm

• Paroxsysmal – Starts and stops suddenly

• Most common SVT• Treated by ablating the slow pathway of the AV Node


Blazer II™ Ablation Catheter Positioning

AVNRT

Sharp electrograms to differentiate A + HIS + V as well as fast and slow AVNODE path ways

Micromovement of catheter from TV to AV Node and from fast to slow pathway

Contact over slow pathway during ablation

4mm Tip Electrode

Bi-Wing Steering Knob and Mechanical Steering Mechanism

HTD Distal + Proximal and Tension Control Knob

CLINICAL REQUIREMENTS CATHETER FEATURES

Normal Sized Hearts = Standard Curve and for Enlarged Hearts = Large Curve

Reach the TV and AV Node

DISEASE CATHETERAVNRT Blazer II

FLUTTER Blazer XPAFIB CHILLI II


Blazer II™ Ablation Catheter Brochure

ClinicalBenefits

TechnicalInfo

OrderingInfo

POSITIONINGPOSITIONING


Blazer II™ Ablation Catheter Brochure


Blazer II™ Ablation Catheter Competition

COMPETITOR PRODUCT BSC SOLUTION

BARD Stinger™ 4mm Blazer II™

St Jude Medical / IBI Therapy™ 4mm Blazer II™Livewire TC™ 4mm Blazer II™Safire™ Blazer II™Triflex™ ───

Biosense Webster Celsius™ 4mm Blazer II™Johnson & Johnson

Medtronic ContactR™ 4mm Blazer II™EnhancR™ Blazer II™ConductR™ 4mm Blazer II™MarinR™ Blazer II™


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


Blazer II™ Ablation Catheter Evaluation Model

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

STEP 1:

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

STEP 2:

The evaluation should be performed with Maestro 3000™ generator.


STEP 3:

Discuss with the Physician whether he/she wishes to use Standard or Large curve


ALL PURPOSEalmost 80% ofAVNRT

LARGEalmost 20% ofAVNRT


STEP 4:Suggest to the Physician to use high torque distal segment (HTD) because of its high performance. However, you may wish to mention to certain physicians that a standard torque distal segment, which minimizes vascular and endocardial trauma, is also available.



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 AVNRT CASES!


Product Units Catheter Units Cable

M004 EPT5031T 0 M004 651 0

3M004 EPT5031TH 0

3 M004 651 0

M004 EPT5031TK2 0

M004 651 0

M004 EPT5031THK2 0

M004 651 0

1 M004 21000TC 0 2 M004 3536010 20

1 M004 21870T 0 3 M004 354 0

2 M004 653S 0

2 M004 613 0

AVNRT EVALUATION CATHETER CHECKLIST

BLAZER II

MAESTRO


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 AVNRT:

Blazer II™ Ablation Catheter How to Use

Power Temperature Time Impedance 45-50w 50-55°C 120sec

Stop based on ECG evaluation

Max 120ohm

Fluro9 o’clock on LAO viewECG keysAVNRT is successfully treated (fast pathway ablation) when A-H Jump is absent


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

Maestro 3000™Troubleshooting Guide


Blazer II™ - Clinical study for FDA approval

Number of patients: 513

ACC Pathway: 257

AVNRT: 126

Other SVT: 130

Acute ACC-Pathway success rate: 81%

Acute AVNRT success rate: 92%

Overall complication rate: 11%

Overall number of deaths: 5

Blazer II™ Ablation Catheter Clinical Evidence


AVNRT Publications:

Radiofrequency ablation of atrioventricular nodal reentry tachycardia: a 14 year experience with 901 patients at the Tel Aviv Sourasky Medical Center.

Topilski et Al.

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

Isr Med Assoc J. 2006 Jul;8(7):455-9.


PRODUCT Biosense-Webster Blazer I I™

SUCCESS RATES 97.3% NUMBER OF PATIENTS 877


AVNRT Publications:

Junctional rhythm quantity and duration during slow pathway radiofrequency ablation in patients with atrioventricular nodal re-entry supraventricular tachycardia.

Iakobishvili et Al.

Rabin Medical Center, Israel 49100.

Europace. 2006 Aug;8(8):588-91. Epub 2006 Jul 10.


PRODUCT Medtronic Mariner™ SUCCESS RATES 92.5% NUMBER OF PATIENTS 40


AVNRT Publications:

Long-term safety and efficacy of slow pathway ablation in patients with atrioventricular nodal re-entrant tachycardia and pre-existing prolonged PR interval.

Pasquie JL, et Al.

Centre Hospitalier Universitaire, Montpellier, France.

Europace. 2006 Feb;8(2):129-33. Epub 2006 Jan 10.


PRODUCT Biosense Webster 4mm SUCCESS RATES 100% NUMBER OF PATIENTS 10 with prolonged PR interval


AVNRT Publications:

Seven-year follow-up after catheter ablation of atrioventricular nodal re-entrant tachycardia.

Maggi R, Quartieri F, et Al.

Ospedali del Tigullio, Lavagna, Italy.

J Cardiovasc Med (Hagerstown). 2006 Jan;7(1):39-44.


PRODUCT 4mm tip SUCCESS RATES 94% NUMBER OF PATIENTS 123


Blazer II™ Ablation CatheterConclusion

Blazer IIBlazer IIPositioningPositioning

AVNRT

ClinicalClinicalNeedsNeeds

•Sharp Electrograms•Micromovement

•Tip Contact

•Reach Anatomy

CustomerCustomerEvaluationEvaluation

•Min 2 AVNRT Cases•BSC Generator•STD or HT Distal?•STD or K2 Curve?•Order per List

Catheter Catheter FeaturesFeatures

•7f/4mm tip electrode•Bi-wing knob and steering mechanism•HTD distal & proximal•St’d curve = normal & K2 = Large

EP SALES TRAINING Blazer II™ Ablation Catheter. BSC Confidential – For Internal Use Only – Do...

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