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IntellaTip MiFi™ XP – Clinical Overview | 11 © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR 2014 IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. IntellaTip MiFi™ XP Ablation Catheter Clinical Overview IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 2 Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 3 Unique Catheter Design 3 Sophisticated Mini-Electrodes • Enable localized recording of a small area • Deliver signals of unparalleled clarity • Allow multiple channels for highly localized EGMs Independent Signal Connector ~ 1 mm diameter Distance from the Tip ~ 2 mm Thermistor Equally Spaced Mini-Electrodes (2.5 mm center-to-center) Electrical Insulation IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 4 Catheter Tip Design ME Signal Wire ME Signal Wire Mini Electrode (ME) ~1mm diameter Adhesive Layer (in between ME Sleeve and Tip) ME Sleeve provides dielectric isolation from tip ME Sleeve 8F Tip Electrode Thermistor IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. Distance of distal end of ME from tip ~ 2mm Mini Electrodes are equally spaced © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 5 System Components IntellaTip MiFi™ XP Temperature Ablation Catheter IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. Cables & Accessories © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 6 IntellaTip MiFi™ Family of Ablation Catheters IntellaTip MiFi XP IntellaTip MiFi OI* 8 mm and 10 mm XP tip 4.5 open irrigated tip US Approval: Q3 2013 OUS Approval: Q2 2014 Japan Approval: Q3 2014 expected** OUS Approval: Q3 2014 expected** US Approval (Type I AFL): Q4 2015 expected** *Investigational Device. Limited by Federal Law to investigational use only. Not available for sale. **These estimates may require revision due to a variety of factors beyond our control. IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 7 IntellaTip™ MiFi Family Indications IntellaTip MiFi™ XP Ablation Catheter • US: Indicated for use with the BSC Maestro 3000® Controller, and Accessories for the treatment of sustained or recurrent type I atrial flutter in patients age 18 or older. • OUS: Indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia – typically chronic, drug refractory atrial fibrillation. IntellaTip MiFi™ Open-Irrigated Catheter* • OUS: Indicated for use in patients who require catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a RF generator, for cardiac ablation. *IntellaTip MiFi OI is pending CE Mark. Not approved for sale in the EAA. Investigational Device. Limited by Federal Law to investigational use only. Not available for sale in the US. IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 8 IntellaTip MiFi™ XP Advantages – 3 Truths True Tip Location Unique design of the IntellaTip MiFi™ XP catheter allows for precise identification of the catheter tip location True Tissue Assessment Highly localized signal allows for distinction between viable and non-viable tissue types that are not detectable with conventional catheters True Ablation Feedback The IntellaTip MiFi™ catheter technology is designed to provide excellent ablation EGM information and transmurality detection in thin tissue IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 9 True Tip Location – High Resolution Recording Highly Localized Recording at the Center of Ablation • Mini-electrodes, located at the distal tip, engineered to reduce the gap between mapping and ablation • Closely positioned mini-electrodes designed to minimize the influence of far-field signals IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 10 Accurate High-Resolution Mapping Maps generated with the mini-electrodes provide accurate information of tip location in relation to the line of block ABLd Conventional electrodes ABLp Mini-electrodes 1-2 Mini-electrodes 2-3 Minielectrodes Conventional electrode recordings suggest the tip electrode is located on the proximal side of the line of block (first potential of double potentials), but the mini-electrode recording shows that the tip electrode is actually located on the distal side (second potential of double potentials).1 Mini-electrodes 1-3 1. Jackman W, et al. (May, 2012). Mini Recording Electrodes Within a Conventional 4.5 mm Tip Electrode Improves Ablation Catheter Mapping Resolution. Poster session presented at Heart Rhythm Society, Boston, MA. (Right Atrial canine model, n=4. Operator utilized Rhythmia Mapping System with 4.5 mm Open-Irrigated IntellaTip MiFi catheter). Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary. IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 11 Tissue Substrate Identification IntellaTip MiFi™ XP technology provides higher specificity and sensitivity in predicting atrial fibrosis and identifying abnormal substrate2 2. Chen S., et al. (May, 2012). A Novel Map and Ablate Technology to Identify Arrhythmogenic Atrial Substrate. Poster session presented at Heart Rhythm Society, Boston, MA. (Right atrial canine model utilizing EnSite NavX™, n=9). Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary. IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 12 Gap Identification High-resolution recording provides sensitivity needed for quick and accurate detection of viable tissue In an atrial flutter clinical trial, EGMs from the mini-electrodes provided information to help identify conduction gaps in the line of block that were not visible using conventional recording3 3. Sanders P. Royal Adelaide Hospital, Australia. Data on File. (MiFi CTI clinical trial, n=10). Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary. IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 Lesion Maturation Feedback (Pre-clinical Model) IntellaTip MiFi™ XP – Clinical Overview | 13 • EGM amplitude reduction, post ablation, was greater when measured with mini-electrodes compared to conventional 8 mm tip⁴ • EGM amplitude reduction on the mini-electrodes, post ablation, was correlated to transmurality⁴ 4. Avitall B, et al. Novel Ablation Catheter Technology that Improves Mapping Resolution, and Monitoring of Lesion Maturation. Journal of Innovations in Cardiac Rhythm Management. 2012; 2:1–11. (Canine model, n=7). Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary. IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 True Ablation Feedback – Transmurality Detection (Pre-clinical Model) IntellaTip MiFi™ XP – Clinical Overview | 14 Effective Transmurality Detection in Thin Tissue IntellaTip MiFi technology detects voltage reduction with higher sensitivity5 5. Chen S, et al, (May, 2012). High Fidelity Ablation Electrogram Recording From A Novel Map and Ablation Technology. Poster session presented at Heart Rhythm Society, Boston, MA. (Canine model, n=5). Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary. IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 15 EGM Attenuation Mini-electrodes demonstrate significant amplitude reduction and signal clarity post ablation as compared to unipolar and bipolar signals Pre-RF RF On End RF V5 CS Bipole 1-2 Bipole 3-4 Unipole 1 Unipole 2 Mini-electrode 1-2 Mini-electrode 2-3 Mini-electrode 3-1 Unipole Mini-electrode 1 Unipole Mini-electrode 2 Case images courtesy of W. Jackman, MD. University of Oklahoma Health Sciences Center. Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary. IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ IntellaTip MiFi™ XP – Clinical Overview | 16 XP Technology Building Knowledge through Academic Research Collaborations Enhanced EGM Resolution to Improve Mapping and Lesion Monitoring Enhanced Substrate Mapping OUHSC - Drs Warren Jackman and Hiroshi Nakagawa MiFi OI, HRS poster 2012 Enhanced mapping resolution Ohio State - Dr John Hummel IntellaTip MiFi XP MiFi XP and MiFi OI Enhanced tip localization Enhanced discrimination of dense scar and border zones in LV myocardial scar Mass General - Dr Moussa Mansour MiFi OI, HRS poster 2013 Enhanced discrimination of late potentials in LV myocardial scar True Tissue Assessment Taipei Vet Hospital - Drs Shi-Ann Chen and Li-Wei Lo MiFi XP and MiFi OI, HRS poster 2012 and 2013 Enhanced identification of atrial arrhythmogenic substrates - sites of atrial fibrosis and critical CFE IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. True Tip Location Univ of Chicago - Dr Boaz Avitall MiFi XP and MiFi OI 1st MiFi Publication Price et al 2012 HRS posters 2012 and 2013 Enhanced EGM discrimination during ablation Taipei Vet Hospital - Drs Shi-Ann Chen/ Li-Wei Lo MiFi XP, HRS poster 2012 Enhanced discrimination of EGM attenuation during ablation True Ablation Feedback OUHSC - Drs Warren Jackman and Hiroshi Nakagawa MiFi OI, HRS poster 2012 Enhanced discrimination of EGM attenuation during ablation BWH - Dr Greg Michaud MiFi OI-R Enhanced resolution during mapping and ablation, pace capture, identification of gaps in lesions © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 17 CLINICAL EXAMPLES EGM and case snapshots from the first 6 months of IntellaTip MiFi™ XP launch: HIS Identification CTI Identification MiFi Attenuation Realtime Ablation Feedback Lesion Gap Assessment with MiFi This case involved use of the IntellaTip MiFi XP Catheter in a single case. Results in other cases may vary. IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. IntellaTip © 2014 byMiFi Boston XP isScientific pending Corporation CE Mark. Notorapproved its affiliates. for sale All rights in thereserved. EEA. EP-237514-AA APR2014 © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 Clinical Cases: MiFi vs. Common Bipoles – HIS? IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. IntellaTip MiFi™ XP – Clinical Overview | 18 © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 Clinical Cases: CTI? IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. IntellaTip MiFi™ XP – Clinical Overview | 19 © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 Clinical Cases: CTI IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. IntellaTip MiFi™ XP – Clinical Overview | 20 © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 IntellaTip MiFi™ XP – Clinical Overview | 21 Clinical Cases: Fluoro images CTI? IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. CTI © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 Clinical Cases: EGM Attenuation – CBP vs. MEs IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. IntellaTip MiFi™ XP – Clinical Overview | 22 © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 Clinical Cases: Gap Identification: Breakthrough on MiFi not evident on CBP IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. IntellaTip MiFi™ XP – Clinical Overview | 23 © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014 MiFi™ IntellaTip XP Temperature Ablation Catheter (US DFU) IntellaTip MiFi™ XP – Clinical Overview | 24 Indications for Use The Boston Scientific Corporation (BSC) IntellaTip MiFi™ XP Catheter is indicated for use with the BSC Maestro 3000® Controller, and Accessories for the treatment of sustained or recurrent type I atrial flutter in patients age 18 or older. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures. Contraindications Do not use this device: • In patients with active systemic infection; Via the transseptal approach in patients with left atrial thrombus or myxoma; Via the retrograde approach in patients with aortic valve replacement. . Warnings Before operating the device, read these warnings carefully: • Peri-procedural anti-coagulation therapy is at the discretion of the physician, however, patients with a history of thromboembolic events may require therapeutic anticoagulation therapy, during and post-ablation to reduce the incidence of major complications. • Because the long-term effects of exposure to ionizing radiation are unknown, careful consideration should therefore be given to pregnant women and pre-pubescent children. • Pacemakers and implantable cardioverter/defibrillators can be adversely affected by RF signals. • It is important to: a. Retain temporary external sources of pacing available during ablation. b. Reprogram the pacing system temporarily to minimum output or 000 mode to minimize risk of inappropriate pacing. c. Exercise extreme caution during ablation when in close proximity to atrial or ventricular permanent pacing leads. d. Perform complete pacing system analysis on all patients after ablation. • Implanted cardioverter/defibrillators should be deactivated during delivery of RF power. • Catheter entrapment within the heart or blood vessels is a possible complication of cardiac ablation procedures. • The potential for catheter entrapment may be increased when the catheter is positioned in the chordae tendinae. The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissue. • Care must be taken to ensure that any equipment used in connection with the BSC catheters, be type CF, be defibrillation proof, meet EN 60601-1 electrical safety requirements, and comply with all local regulatory requirements for the specified intended use. • Maximum IntellaTip MiFi XP Catheter Rated Voltage: 178 Vrms (251 Vpk). No modification of this equipment is allowed. • In the presence of anticoagulation, there may be an increased risk of bleeding from all causes. If there is uncertainty regarding the patient’s anticoagulation status or rhythm prior to the atrial flutter procedure, there should be a low threshold to perform a transesophageal echocardiogram (TEE) prior to the procedure to confirm absence of thrombus in the left atrial appendage. • Do not pass the IntellaTip MiFi XP Catheter through any prosthetic heart valve (mechanical or tissue), as this may cause entrapment of the catheter and/or damage to the prosthetic heart valve, resulting in valvular insufficiency and/or premature failure of the prosthetic valve. Precautions • The IntellaTip MiFi XP Catheters are intended for use with the BSC Controller and accessories only. • Overrotating the handle and catheter shaft may cause damage to the distal tip or catheter assembly. • Do not rotate the handle and catheter shaft more than one and one-half times the full rotation (540 degrees). • If the desired catheter tip position is not achieved, adjust the catheter’s curve to disengage the catheter tip from the heart wall before resuming rotation of the handle and catheter shaft. • Careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade. • Catheter advancement should be done under fluoroscopic guidance. • Do not use excessive force to advance or withdraw the catheter when resistance is encountered. • Manual pre-bending of the distal curve can damage the steering mechanism and may cause patient injury. • Unlike with conventional catheters, a sudden rise in system impedance is not an indication of coagulum formation. Therefore, to minimize coagulum, it is recommended that the catheter periodically be removed and the distal tip cleaned after each line of block. • When using the IntellaTip MiFi XP Catheter, it is required that two Dispersive Indifferent Patch (DIP) Electrode Pads satisfying the requirements of IEC 60601-1/IEC 60601-1-2 be used as the ablation return electrodes or skin burns may result. • Placement of the DIP electrodes on the thigh could be associated with higher impedance, which could result in automatic RF power shut-off. • During power delivery, the patient should not be allowed to come in contact with grounded metal surfaces. • Do not increase power before checking for obvious defects or misapplication.. Potential Adverse Events Potential adverse events (in alphabetical order), that may be associated with cardiac catheterization and ablation include, but are not limited to: • Allergic reaction (including anaphylaxis), angina, arrhythmias, arterial or pulmonary embolism, arterial-venous fistula, atrioventricular node damage (transient/permanent), back pain and/or groin pain, cardiac perforation, cardiac respiratory arrest, catheter entrapment, complete heart block (transient/permanent), cerebral vascular accident, chest pain/discomfort, complications of sedative agents (e.g. aspiration pneumonia), death, effusion (pericardial/pleural), hematoma/bruising, hemoptysis, hemorrhage, hemothorax, hypotension, infection, myocardial infarction, nerve palsy or weakness, pericarditis, phrenic nerve damage/diaphragmatic paralysis, pleurisy, pneumothorax, pulmonary edema, pseudoaneurysm, radiation exposure, sinoatrial node damage, skin burn (defibrillator/cardioverter/radiation), tamponade, transientischemic attack (TIA), valvular damage, vasovagal reactions, visual blurring. IntellaTip MiFi XP is pending CE Mark. Not approved for sale in the EEA. © 2014 by Boston Scientific Corporation or its affiliates. All rights reserved. EP-237514-AA APR2014