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

BSC Confidential – For Internal Use Only – Do Not Copy or Distribute Blazer II™ Ablation Catheter Agenda 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 BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

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

Blazer II™ & Blazer II HTD™ Feature Summary BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

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 NSR – conduction through the AV node via the fast pathway BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter AVNRT 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 BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter AVNRT 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 BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

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

BSC Confidential – For Internal Use Only – Do Not Copy or Distribute Blazer II™ Ablation Catheter Positioning BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter Brochure Clinical Benefits POSITIONING Technical Info Ordering Info BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter Brochure BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter Competition BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

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-TH item 85864) Blazer II™ (thermistor sensor) cannot be used with Medtronic generator ATAKR™. BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

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

Blazer II™ Ablation Catheter Evaluation Model STEP 3: Discuss with the Physician whether he/she wishes to use Standard or Large curve BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter Evaluation Model 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. BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ 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 AVNRT CASES! BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ 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. BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter Evaluation Model BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter How to Use General Settings for AVNRT: Fluro 9 o’clock on LAO view ECG keys AVNRT is successfully treated (fast pathway ablation) when A-H Jump is absent BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Maestro 3000™ Troubleshooting Guide 11 error codes exist. Here listed meaning & solution. Brochure available. BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter Clinical Evidence 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 BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

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

Blazer II™ Ablation Catheter Clinical Evidence 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. BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter Clinical Evidence 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. BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter Clinical Evidence 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. BSC Confidential – For Internal Use Only – Do Not Copy or Distribute

Blazer II™ Ablation Catheter Conclusion Positioning AVNRT Clinical Needs Sharp Electrograms Micromovement Tip Contact Reach Anatomy Catheter Features 7f/4mm tip electrode Bi-wing knob and steering mechanism HTD distal & proximal St’d curve = normal & K2 = Large Customer Evaluation Min 2 AVNRT Cases BSC Generator STD or HT Distal? STD or K2 Curve? Order per List BSC Confidential – For Internal Use Only – Do Not Copy or Distribute