Transcript Document

EP Sale’s Training

Summary

EP Summary - Agenda

• Diagnostic Catheters – EP Study • Ablation Catheter Features • Blazer II™ Ablation Catheter –

AVNRT

• Blazer XP™ Ablation Catheter –

A Flutter

• Chilli II ™ Cooled Ablation Catheter –

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

Diagnostic Catheters

EP Study

Sinus Rhythm: regular slim QRS P before Q P: > 90 ms PQ: 120 – 200 ms QRS: < 120 ms QT: ca. 440ms

R T P Q S

P – Q QRS Q - T

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Diagnostic Catheters

EP Study

High Right Atrium (near sinus node) His (near AV node) Coronary Sinus (left AV groove) (used for left AVRT, Flutter and A fib) Right Ventricle Apex

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Diagnostic Catheters

EP Study

CLINICAL REQUIREMENTS

Access from the femoral vein Stability upper posterior of RA for signal fidelity and pacing capture Timing of conduction at HRA

CATHETER FEATURES

Pushablity and trackability of proximal tubing.

Distal tubing material and braid reinforcement 5mm or 10mm bipoalr or quadripolar spacing

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Diagnostic Catheters

EP Study

CLINICAL REQUIREMENTS

Access from femoral vein Access to the septal portion of the TV from the IVC Stablity at the TV for signal fidelity

CATHETER FEATURES

Pushablity and trackability of proximal tubing.

Multipurpose curve Distal tubing material and braid reinforcement Minimal trauma to the AV Node and HIS Timing and Morphology of conduction from RA to RV, including HIS signal Non braided distal tubing 2 mm quadripolar or hexapolar spacing

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Diagnostic Catheters

EP Study

CLINICAL REQUIREMENTS

Access from the femoral vein

CATHETER FEATURES

Pushablity and trackability of proximal tubing.

Access to the CS ostium from IVC Trackability over the "lip" at the entrance to the CS Trackability to push the catheter to the distal posterior section of the CS Morphology and timing along the length of the CS, including the CS ostium.

Standard Steerable Curve Pushability and torqueability of proximal tubing & steering of catheter.

Pushablity and trackability of proximal tubing.

2.5 - 5 - 2.5 or similar decapolar spacing

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Diagnostic Catheters

EP Study

CLINICAL REQUIREMENTS

Access from the femoral vein Cross the TV from the IVC Stability at the Apex of the RV for signal fidelity and pacing capture Minimize perforation of the RV Apex Timing of conduction at RVA

CATHETER FEATURES

Pushablity and trackability of proximal tubing.

Josephson/Cournand Curve Distal tubing material and braid reinforcement Non braided distal tubing 5mm or 10mm bipoalr or quadripolar spacing

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Diagnostic Catheters

Clinical Applications

CATHETER FAMILIES Fixed

Explorer Explorer 360 Explorer 360jr Explorer 5f ST Explorer 6f ST

Steerable

Polaris Dx Polaris X SteeroCath-Dx

HRA

HEART LOCATION

CS HIS RVA

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Josephson Cournand Multipurpose  

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Conduction

Steerable

Standard (180º) Standard (270º) Longest 

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Diagnostic Catheters

Fixed Curve

CURVE SHAPES CONNECTORS DISTAL TUBING

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Diagnostic Catheters

Fixed Curve Features

Features TUBING FRENCH SIZE

6f 5f

DISTAL TUBING FIRMNESS

High Performance Less Traumatic

RING ELECTRODE SPACING

Bipolar Quadripolar Decapolar

DISTAL FIXED CURVE SHAPES

Josephson Cournand Multipurpose Conduction

PROXIMAL TUBING CONNECTOR

High Performance Pins Rotary - 4 pin QC - 4 pin QC - 10 pin

Explorer FIXED CURVE FAMILIES Explorer 360 Explorer 360 Jr Explorer 5f ST Explorer 6f ST

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Diagnostic Catheters

Steerable

POLARIS X STEEROCATH DX POLARIS Dx

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Diagnostic Catheters

Steerable Features

Features STEERABLE FAMILIES Polaris Dx Polaris X Steerocath - Dx TUBING FRENCH SIZE

7f 6f

DISTAL TUBING FIRMNESS

High Performance Less Traumatic

RING ELECTRODE SPACING

Quadripolar Hexapolar Octapolar Decapolar

DISTAL FIXED CURVE SHAPES

Standard (270º) Standard (180º) Longest

PROXIMAL TUBING

High Performance

CONNECTOR

Rotary - 4 pin QC - 6 pin QC - 8 pin QC - 10 pin

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Diagnostic Catheters

Conclusion

The purpose of diagnostic catheters is to facilitate understanding the mechanism of arrythmias and appropriate ablation location.

Diagnostic Catheter can be classified into two main groups:  Fixed Catheters  Steerable Catheters Both type of catheters present a wide range of configurations (i.e. curve type, electrode numbers, electrode spacing etc.). The main difference between fixed and steerable catheters is the CLINICAL ease of use: the target for steerable catheters is mapping difficult sites, like the CS.

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Ablation Catheter Features

Handle

• Tension Control •Bi-wing Steering •Handle Ergonomics

Distal Segment

• Length & Curve Shape • Performance • Active Steering

Tip Electrode

•Tip Size •Cooling •Temperature Sensor

Proximal Shaft

•Torqueability •Pushability •Trackability

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Blazer II™ Ablation Catheter

AVNRT

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

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Blazer II™ Ablation Catheter

Feature Summary

DISTAL SHAFT CHARACTERISTICS CATHETER FAMILY CONFIGURATIONS Blazer II™ Blazer II™ HTD Blazer II XP™ Blazer II XP™ HTD Chilli II™ Tubing Lengths

Standard Medium Extended

Tubing Firmness

Standard Torque High Torque

Curve Shapes

Small Standard Large Asymmetric

Cooling

Passive Active

Tip Electrode

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

Temperature Sensor

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Blazer II™ Ablation Catheter

Positioning

DISEASE AVNRT FLUTTER AFIB CATHETER Blazer II Blazer XP CHILLI II AVNRT CLINICAL REQUIREMENTS

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

CATHETER FEATURES

4mm Tip Electrode Micromovement of catheter from TV to AV Node and from fast to slow pathway Bi-Wing Steering Knob and Mechanical Steering Mechanism Contact over slow pathway during ablation Reach the TV and AV Node HTD Distal + Proximal and Tension Control Knob Normal Sized Hearts = Standard Curve and for Enlarged Hearts = Large Curve

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Blazer II™ Ablation Catheter

How to Use

General Settings for AVNRT: Power 45-50w Temperature 50-55°C Time 120sec Stop based on ECG evaluation Impedance Max 120ohm Fluro 9 o’clock on LAO view ECG keys AVNRT is successfully treated (fast pathway ablation) when A-H Jump is absent

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Blazer II™ Ablation Catheter

Conclusion

Blazer II Positioning Clinical Needs Catheter Features Customer Evaluation AVNRT

•Sharp Electrograms •Micromovement •Tip Contact •Reach Anatomy •7f/4mm tip electrode •Bi-wing knob and steering mechanism •HTD distal & proximal •St’d curve = normal & K2 = Large •Min 2 AVNRT Cases •BSC Generator •STD or HT Distal?

•STD or K2 Curve?

•Order per List

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Blazer II XP™ Ablation Catheter

Atrial Flutter

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

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Blazer II XP™ Ablation Catheter

Feature Summary

DISTAL SHAFT CHARACTERISTICS CATHETER FAMILY CONFIGURATIONS Blazer II™ Blazer II™ HTD Blazer II XP™ Blazer II XP™ HTD Chilli II™ Tubing Lengths

Standard Medium Extended

Tubing Firmness

Standard Torque High Torque

Curve Shapes

Small Standard Large Asymmetric

Cooling

Passive Active

Tip Electrode

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

Temperature Sensor

Exposed Imbedded Thermistor Thermocouple         

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Blazer II XP™ Ablation Catheter

Positioning

DISEASE

AVNRT FLUTTER AFIB

CATHETER

Blazer II Blazer XP CHILLI II FLUTTER CLINICAL 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 Reach the TV HTD Distal + Proximal tubing Normal Sized Hearts = Large Curve and for Enlarged Hearts = Large Curve + Sheath (5890ST)

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Blazer II XP™ Ablation Catheter

How to Use

General Settings for FLUTTER: Power 65-70w Temperature Time 65-75°C 120 sec - Stop based on ECG evaluation - Drag lesions will need multiple ON/OFF Fluro 6 o’clock on LAO view ECG keys Bidirectional isthmus block Impedance Max 120ohm

Blazer II XP ™ Ablation Catheter

Conclusion

Blazer II XP Positioning Clinical Needs Catheter Features Customer Evaluation Flutter

•Deep Lesion •Linear Ablation •Tip Contact •Reach Anatomy •8f/8mm Tip Electrode •Bi-wing knob and mechanical steering •HT distal and proximal tubings •Large Curve •Min 2 AFL Cases •BSC Generator •Straight or VM Tip?

•STD or HT Distal?

•K2 or STD Curve?

•Order per List

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Chilli II ™ Cooled Ablation Catheter

Atrial Fibrillation

Summary

• Symptoms – Palpitations – Dizziness – Short of Breath • Rhythm – Narrow QRS – Irregular – Paroxysmal, Persistant and Permanent • Ablation – Encirclement of the Pulmonary Veins – Possible other left atrial connecting lesions

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Chilli II ™ Cooled Ablation Catheter

Feature Summary

DISTAL SHAFT CHARACTERISTICS CATHETER FAMILY CONFIGURATIONS Blazer II™ Blazer II™ HTD Blazer II XP™ Blazer II XP™ HTD Chilli II™ Tubing Lengths

Standard Medium Extended

Tubing Firmness

Standard Torque High Torque

Curve Shapes

Small Standard Large Asymmetric

Cooling

Passive Active

Tip Electrode

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

Temperature Sensor

Exposed Imbedded Thermistor Thermocouple         

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Chilli II™ Cooled Ablation Catheter

Positioning

DISEASE

AVNRT FLUTTER AFIB

CATHETER

Blazer II Blazer XP CHILLI II ATRIAL FIBRILLATION CLINICAL REQUIREMENTS CATHETER FEATURES

Reduce risks of secondary complications of coagulum/thrombus formation that may result in ITAs or strokes.

Cooled 7f,4mm tip electrode Reduce risk of secondary complications associated with fluid overload such as pulmonary insufficiency, etc.

Closed Loop, reciruculating cooling fluid Micromovement to create linear lesion Stable tip contact throughout linear lesion Bi-Wing Steering Knob and Mechanical Steering Mechanism HTD Distal + Proximal tubing Access and movement around the LA Deep lesions for the Roof, Foot, and MV of the LA where the Atrial Tissue is thick Proximal tubing + Bi-directional Steering Cooled 7f,4mm tip electrode

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Chilli II™ Cooled Ablation Catheter

How to Use

Arrhythmia AFIB FLUTTER Generator Maximum Values POWER

35W

TEMP

47ºC

TIME

30sec 45W 47ºC 30sec

Cardiac Tissue Coronary Sinus Scar Tissue Thick Tissue Generator Initial Settings Hi Flow POWER Lo Flow/ Coag TEMP

15W ---- 41ºC

TIME

30 sec 30W 30W 25W 25W 47ºC 47ºC 30sec 30sec

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Chilli II ™ Cooled Ablation Catheter

Conclusion

Chilli II Positioning Clinical Needs Catheter Features Customer Evaluation AFIB

•Minimize Coagulum •Minimize secondary complications •Linear Ablation •Tip Contact •Access Anatomy •Deep Lesion •Cooled 7f/4mm Tip •Closed loop cooling •Bi-wing Knob & mechanical steering •HT Distal and Proximal •Active Steering & proximal tubing •Cooled 7f/4mm •1 x AFL + 1 x AFIB Cases •BSC Generator •STD & K2 backup •Order per List

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EP Summary

Clinical Summary

Sinus Rhythm AVNRT Rate (average)

60 - 80 bpm

Regular Rhythm

yes 160 - 200 bpm yes

P before QRS

yes no

Narrow QRS Testing

yes yes EP Study AH jump, AV < 50msecs

AVRT A Flutter V Tach A fib

160 - 200 bpm yes a=200 250msec regular in atrium no (p after q) yes 150-250 bpm yes no a >200 msecs irregular no p wave either AV time > 50 msecs yes Bidirectional block no yes EP Study Isolated PVs

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