Download IntellaTip MiFi XP

IntellaTip MiFi™ XP – Clinical Overview | 11
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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