Chilli II™ Cooled Ablation Catheter EP SALES TRAINING Chilli II™ Cooled Ablation Catheter

BSC Confidential. For Internal Use Only. Do not Copy or Distribute Chilli II™ Cooled Ablation Catheter Agenda Chilli II™ - Features Atrial Fibrillation Positioning Internal vs. External 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 Chilli II™ Cooled 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

Chilli II™ Cooled Ablation Catheter Feature Summary BSC Confidential. For Internal Use Only. Do not Copy or Distribute

CircuCool ™ Pump Features Settings Flow Rate: Constant: 0.6 ml/sec or 36ml/min Pressure Limit: Less than 300 psi Dimensions and Weight Height: 9.0” (22.9 cm) Width: 11.0” (27.9 cm) Depth: 11.80” (30.0 cm) Weight: 9.6 pounds (4.4 kg) Special Note: Pump comes with US power plug. Need to order appropriate EU country plug BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Atrial Fibrillation Anatomy & Conduction Left Atrium Four PVs enter the left atrium (left, right, superior and inferior) A fib thought to originate in the PVs Thought to be a triggered tachycardia Three Types Paroxysmal starts and stops spontaneously Variable durations Persistent starts spontaneously stops only with electrical or medical cardioversion Permanent present all the time restoring sinus rhythm is not possible BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Atrial Fibrillation Mapping Atrial Fibrillation Dx placed in CS and in PVs CS = to pace the left atrium Decapolar PVs = to check for electrical activity and isolation Laso, Mesh, Constellation catheters Rx in left atrium Done with a transeptal puncture across the septum BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Atrial Fibrillation Ablating Atrial Fibrillation Various techniques but essentially try to isolate the PVs by encircling and possibly making other connecting linear lesions BSC Confidential. For Internal Use Only. Do not Copy or Distribute

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 BSC Confidential. For Internal Use Only. Do not Copy or Distribute

BSC Confidential. For Internal Use Only. Do not Copy or Distribute Chilli II™ Cooled Ablation Catheter Positioning BSC Confidential. For Internal Use Only. Do not Copy or Distribute

BSC Confidential. For Internal Use Only. Do not Copy or Distribute Chilli II™ Cooled Ablation Catheter Internal vs. External Not a major safety concern in most patients…. BUT: Consider that 1l of normal saline contains 9grams of sodium chloride, which includes 3.6grams of sodium – patients with heart failure (CHF) or hypertension are typically advised to reduce the sodium in their diet to 2.4 grams daily. In addition to the volume load, each liter of saline irrigation contains 1,000 units of heparin. Thus, there is the potential for greater anticoagulation that would be achieved without open- irrigation. Factors that predispose to pulmonary edema: Heart Failure (CHF) Heart disease (AV disease, MV disease, EF<35%, miocardial infarction) Renal insufficiency Diabetes mellitus Advanced age Multi-system disease (i.e. Autoimmune disease) or aggressive therapy (chemiotherapy or radiotherapy) “Irrigated RF ablation: power titration and fluid management for optimal safety and efficacy”, Stevenson et al. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

BSC Confidential. For Internal Use Only. Do not Copy or Distribute Chilli II™ Cooled Ablation Catheter Internal vs. External Consequences of Saline Administration during Irrigation: Increase of venous pressure increase in renal excretion pulmonary edema: increase respiratory rate agitation dyspnea tachycardia decrease of peripheral oxigen saturation extremities edema For this reasons eventual later treatment become necessary: administration of oxygen administration of intravenous diuretic drugs administration of inotropic agents (i.e. dopamine) endotracheal intubation and assisted ventilation “Irrigated RF ablation: power titration and fluid management for optimal safety and efficacy”, Stevenson et al. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Brochure Clinical Benefits POSITIONING Technical Info Ordering Info BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Brochure BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Brochure Clinical Benefits Technical Info POSITIONING Ordering Info BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Brochure BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Brochure Set Up Guide Troubleshooting Guide Ordering Info BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Competition BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Competition BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Cabling Chart Catheter can be connected to: ▪ EPT 1000XP™ generator (BSC) Serial Number above ▪ Maestro 3000™ generator (BSC) ▪ Stockert generator ▪ Osypka generator Chilli II™ cannot be used with Medtronic and IBI generators. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Cabling Chart Connection with Navx System (St Jude Medical) BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Evaluation Model When preparing the evaluation of new customer please follow the SIX easy steps outlined below: STEP 1: Schedule minimum two cases either the same or successive days: Blazer - NO EXPERIENCE schedule one FLUTTER and one AFIB case; Blazer - EXPERIENCED schedule two AFIB cases. STEP 2: The evaluation is to be performed with a BSC RF Generator Maestro 3000™. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Evaluation Model STEP 3 (FOR FLUTTER ONLY): Suggest to Physician to use the Blazer II XP™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. Reach and Large Hearts BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Evaluation Model STEP 4 (FOR AFIB ONLY): : Suggest to the physician to use Chilli II™ Standard Curve and order a Large Curve as a backup for physicians with sheath manipulation and trackability issues. All- Purpose And Most Robust Large Hearts And Distal Flexibility BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled 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. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled 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

Chilli II™ Cooled Ablation Catheter Evaluation Model BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Evaluation Model Connection with Navx System (St Jude Medical) BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter How to Use BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter How to Use ECG keys AFIB: PV isolation (no double potential where previously seen) Ablation Problem High impedance: Char or coagulum on the catheter tip: wipe catheter Poor contact: need better reposition for better tip contact 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 AMP or POD BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Maestro 3000™ Troubleshooting 11 error codes exist. Here listed meaning & solution. Brochure available. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “Clinical study of the efficacy of a cooled-tip catheter ablation system for common atrial flutter.” Okishige K et Al. Cardiovascular Center, Yokohama Red Cross Hospital, Japan. okishige@yo.rim.or.jp Circ J. 2004 Jan;68(1):73-6. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “Prospective randomized comparison of cooled radiofrequency versus standard radiofrequency energy for ablation of typical atrial flutter.” Atiga WL, et Al. University of Pittsburgh Medical Center, Pennsylvania, USA Pacing Clin Electrophysiol. 2002 Aug;25(8):1172-8. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “Randomized comparison of efficacy of cooled tip catheter ablation of atrial flutter: anatomic versus electrophysiological complete isthmus block.” Madrid AH, et Al. Cardiology Department, Ramon y Cajal Hospital, Madrid, Spain. Pacing Clin Electrophysiol. 2001 Oct;24(10):1525-33. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “Prospective randomized comparison of irrigated-tip versus conventional-tip catheters for ablation of common flutter.” Jais P et Al. Hopital Cardiologique du Haut-Leveque, Bordeaux-Pessac, France. Circulation. 2000 Feb 22;101(7):772-6. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “Pattern of isthmus conduction recovery using open cooled and solid large-tip catheters for radiofrequency ablation of typical atrial flutter.” Ventura R, University Hospital Hamburg-Eppendorf, Hamburg, Germany. J Cardiovasc Electrophysiol. 2004 Oct;15(10):1131-2. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “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. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “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. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “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, Munich, Germany. Cardiovasc Electrophysiol. 2002 Oct;13(10):980-5 BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “Primary closed cooled tip ablation of typical atrial flutter in comparison to conventional radiofrequency ablation.” Spitzer SG, et Al. Institute of Cardiovascular Research, Dresden, Germany. Europace. 2002 Jul;4(3):265-71. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “Prospective randomised comparison of irrigated-tip and large-tip catheter ablation of cavotricuspid isthmus-dependent atrial flutter.” Scavee C, Jais P, Haissaguerre M, et Al. Hopital Cardiologique du Haut-Leveque, Bordeaux-Pessac, France. Eur Heart J. 2004 Jun; 25(11): 963-9. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “Predictors of recurrence following catheter ablation of atrial fibrillation using an irrigated-tip ablation catheter.” Vasamreddy CR, et Al. Johns Hopkins University School of Medicine, Baltimore, USA. J Cardiovasc Electrophysiol. 2004 Jun;15(6):692-7. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “Saline-cooled versus standard radiofrequency catheter ablation for infarct-related ventricular tachycardias.” Soejima K, et Al. Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. Circulation. 2001 Apr 10;103(14):1858-62. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Clinical Evidence “Catheter ablation of ventricular tachycardia in patients with structural heart disease using cooled radiofrequency energy: results of a prospective multicenter study.” Calkins H, et Al. Johns Hopkins University School of Medicine, Baltimore, USA. J Am Coll Cardiol. 2000 Jun;35(7):1905-14. BSC Confidential. For Internal Use Only. Do not Copy or Distribute

Chilli II™ Cooled Ablation Catheter Conclusion Positioning AFIB Clinical Needs Minimize Coagulum Minimize secondary complications Linear Ablation Tip Contact Access Anatomy Deep Lesion Catheter Features Cooled 7f/4mm Tip Closed loop cooling Bi-wing Knob & mechanical steering HT Distal and Proximal Active Steering & proximal tubing Cooled 7f/4mm Customer Evaluation 1 x AFL + 1 x AFIB Cases BSC Generator STD & K2 backup Order per List BSC Confidential. For Internal Use Only. Do not Copy or Distribute