Blazer II XP™ Ablation Catheter EP SALES TRAINING Blazer II XP™ Ablation Catheter

Blazer II XP™ Ablation Catheter Agenda 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 Catheter Features 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 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

Blazer II XP™ Ablation Catheter Atrial Flutter 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.

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

Blazer II XP™ Ablation Catheter Positioning

Blazer II XP™ Ablation Catheter Brochure Clinical Benefits POSITIONING Technical Info Ordering Info

Blazer II XP™ Ablation Catheter Brochure

Blazer II XP™ Ablation Catheter Competition

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-TH item 85864) Blazer II XP™ (thermistor sensor) cannot be used with Medtronic generator 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.

Blazer II XP™ Ablation Catheter Evaluation Model 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

Blazer II XP™ Ablation Catheter Evaluation Model 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.

Blazer II XP™ Ablation Catheter Evaluation Model 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!

Blazer II XP™ Ablation Catheter Evaluation Model 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.

Blazer II XP™ Ablation Catheter Evaluation Model

Blazer II XP™ Ablation Catheter How to Use General Settings for FLUTTER: Fluro 6 o’clock on LAO view ECG keys Bidirectional isthmus block

Blazer II XP™ Ablation Catheter How to Use Ablation Problem High 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 Turn OFF/ON generator to verify proper function

Blazer II XP™ Ablation Catheter How to Use Ablation Problem Measured 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 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

Maestro 3000™ Troubleshooting Guide 11 error codes exist. Here listed meaning & solution. Brochure available.

Blazer II XP™ Ablation Catheter Clinical Evidence 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 enrolled 21 active sites Max number of cases per site 30 Technique Success Rates: Acute: 94% Recurrence rate (6 months): 4% Adverse Event Rates Major: 8%

Blazer II XP™ Ablation Catheter Clinical Evidence 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.

Blazer II XP™ Ablation Catheter Clinical Evidence FLUTTER Publications: “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.

Blazer II XP™ Ablation Catheter Clinical Evidence FLUTTER Publications: “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

Blazer II XP™ Ablation Catheter Clinical Evidence FLUTTER Publications: 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 Catheter Conclusion Positioning Flutter Clinical Needs Deep Lesion Linear Ablation Tip Contact Reach Anatomy Catheter Features 8f/8mm Tip Electrode Bi-wing knob and mechanical steering HT distal and proximal tubings Large Curve Customer Evaluation Min 2 AFL Cases BSC Generator Straight or VM Tip? STD or HT Distal? K2 or STD Curve? Order per List