PEARL REGISTRYPost Market Registry Real World Use of the AngioJet™ Thrombectomy System in the Peripheral Vascular System
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Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV)
PI-315422-AA JUN2015 © 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Objectives AngioJet Action Enrollment General Indications & Contraindications
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV)
Overview Two-phase, prospective, non-randomized multi-center registry
PEARL I (January 2007 - April 2010): Followed patients for 3 months with documentation of symptomatic improvement after rheolytic thrombectomy (with mid-length catheters)
PEARL II (March 2010 - June 2013): Followed patient outcomes through 12 months after rheolytic thrombectomy with any AngioJet catheter
All patients were treated with AngioJet™ catheters
Patient history, procedural information, adjunctive treatments, outcomes and adverse events were collected
Patients were analyzed in arterial, venous & dialysis access indications
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Objectives AngioJet Action Enrollment General Indications & Contraindications
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV)
Objectives Determine efficacy of thrombus removal from baseline to final angiogram/venogram
Evaluate clinical outcomes of treated patients at defined intervals of 3, 6 & 12 months
Characterize clinical events
Characterize treatment options used with the AngioJet™ System
Estimate rate of AngioJet Thrombectomy-related adverse events
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Objectives AngioJet Action Enrollment General Indications & Contraindications
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV)
AngioJet™ Mechanism of Action The Bernoulli Effect explains the relationship between velocity and pressure.
Pressurized saline jets travel backwards to create a low pressure zone causing a vacuum effect.
Cross-Stream™ windows optimize the drawing action for more effective thrombus removal.
Thrombus is drawn into the catheter where it is fragmented by the jets and evacuated from the body.
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Objectives AngioJet Action Enrollment General Indications & Contraindications
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV)
Enrollment I N=952 patients
371 (39%)Deep Venous Thrombosis (DVT)
410 (43%)Limb Ischemia (LI)
145 (15%)Hemodialysis Access (HA)
26 (3%) Other
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
DEEP VEIN THROMBOSISPresented by Dr. Mark Garcia at CIRSE 2013
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
DVT Baseline Characteristics
Demographics/Risk Factors
Age (years) 52 (±16.0)
Gender (male) 214 (58%)
Previous DVT 136 (37%)
Pre-existing caval filter 93 (25%)
Malignancy 34 (9%) current; 27 (7%) past
Pulmonary Embolism 44 (12%) current; 60 (16%) past
Recent Surgery 49 (13%)
Hypercoagulability 41 (11%)
Immobilization 30 (8%)
May Thurner 30 (8%)
Oral Contraceptives 22 (6%)
Recent Travel 9 (2%)
Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
DVT Age by Onset
Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
Acute
24 Hours 18 (5%)
256/371 (69%)
> 24 Hours and 7 Days 158 (43%)
> 7 Days and 14 Days 80 (22%)
Sub Acute > 14 Days and 30 Days 68 (18%) 68/371 (18%)
Chronic
> 30 days and 3 Months 33 (9%) 47/371 (13%)
> 3 Months and 6 Months 8 (2%)
> 6 Months 6 (1%)
69% of patients report symptom onset of ≤ 14 days
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
DVT Technique Subgroups
CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysisGarcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
Treatment Frequency
AngioJet Thrombectomy alone (no lytic) “Rheolytic”
20 (5%)
AngioJet + Lytic by AngioJet “PMT”
129 (35%)
AngioJet “Rheolytic” + CDT 32 (9%)
AngioJet “PMT” + CDT 190 (51%)
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
DVT Adjuvant Therapies
CDT, catheter-directed thrombolysis. IVC, inferior vena cava. Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
Therapy Frequency
Stent 119 (32%)
IVC Filter Placement 85 (23%)
Catheter Directed Thrombolysis 222 (60%)
Balloon Angioplasty 277 (75%)
Other Thrombectomy 22 (6%)
Surgical Decompression (ie . rib resection)
3 (<1%)
No CDT needed– 149 (40%)
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Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
DVT Duration of Procedure N=355*
*(355/371 had times recorded)
Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
38% completed in ≤ 6 hours 75% completed in ≤ 24 hours
Time Period Frequency
6 Hrs 133 (38%)
> 6 Hrs & 12 Hrs 37 (10%)
> 12 Hrs & 24 Hrs 97 (27%)
>24 Hrs 88 (25%)
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
DVT Number of Lab Sessions N=359*
*(359/371 had # sessions recorded)
Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
87% had 2 or less sessions
Session = In and Out of Interventional Suite
# of Sessions N(%)
1 123 (34%)
2 189 (53%)
3 40 (11%)
>3 7 (2%)
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
DVT Renal Test Comparisons
Wilcoxon Signed Rank Test*Paired analysisGarcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
Analyte Pre-procedure
Mean
Post-procedure
Mean
Mean Difference*
PValue
BUN (N=235) 16.8 16.4 -0.4 0.1030
Creatinine (N=239) 1.1 1.2 0.1 0.0848
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
Venographic Results N=1295 vessels treated (p<0.0001)
Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
0 10 20 30 40 50 60 70 80 90
100
Improved Unchanged Worsened
97
3 <1
% o
f T
reat
ed V
esse
ls
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Select from these topics
Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
Venographic Results by Technique Subgroups (p<0.0001) N=1295 vessels treated
CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysis Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
0 10 20 30 40 50 60 70 80 90
100
RheolyticThrombectomy
N=44
100
0 0
% o
f T
reat
ed V
esse
ls
PMTN=389
97
3 0
PMT+ CDTN=751
97
3 <1
RheolyticThrombectomy
+CDTN=111
Improved
Unchanged
Worsened
94
5 <1
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Select from these topics
Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
Venographic Results clot age by symptom onset (p<0.0001)
Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
0 10 20 30 40 50 60 70 80 90
100
<= 24 HrsN=64
100
0 0
% o
f T
reat
ed V
esse
ls
7-14 DaysN=306
97
3 0
1-7 DaysN=533
ACUTE DVT
97
3 <1
Improved
Unchanged
Worsened
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Select from these topics
Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
Venographic Results clot age by symptom onset (p<0.0001)
Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
0 10 20 30 40 50 60 70 80 90
100
>3 MonthsN=40
100
0 0
% o
f T
reat
ed V
esse
ls
30-90 DaysN=126
93
70
14-30 DaysN=226
SUBACUTE CHRONIC
97
2 1
Improved
Unchanged
Worsened
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
➦
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Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
Maintained Benefits DVT: Freedom from Rethrombosis
* Estimated by Kaplan Meier Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
0 10 20 30 40 50 60 70 80 90
100
365 Days
% P
ts F
ree
fro
m R
eth
rom
bo
sis
180 Days90 Days
Days Post Procedure
9488
84
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Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
Maintained Benefits DVT: Maintained Clinical Benefit*
* Estimated by Kaplan Meier Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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0 10 20 30 40 50 60 70 80 90
100
365 Days
% P
ts M
ain
tain
ing
Clin
ical
Ben
efit
180 Days90 Days
Days Post Procedure
93
8278
Select from these topics
Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
Patient Quality of Life DVT: SF 12 QOL (PEARL II Only)
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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There are statistically significant improvements measured by the physical (p<0.0001) and mental (p<0.0001) components. The pretreatment physical scores differ significantly from the 3, 6 & 12 month follow ups QOL, quality of life
Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
05
101520253035404550
6 MonthsN=153
QO
L M
ean
Sco
res
3 MonthsN=173
BaselineN=186
33.3
44.041.6
48.5
41.5
48.1
12 MonthsN=151
42.8
48.9
Physical
Mental
Select from these topics
Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
DVT Events
Events where the AngioJet™ could not be ruled out as a contributing factor.
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
➦➦MORE* Patient
CVA, cerebrovascular accident; PE, pulmonary embolism Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013
N Relationship to Event AngioJet Status
Arrhythmia 3 3 Unknown Resolved
Acute Renal Failure 1 Yes Resolved
Transient Renal Insufficiency 1 Unknown Resolved
Elevated Creatinine (1.1 to 1.7) 1 Unknown Resolved
PE (not treated) 1 Unknown Resolved
CVA (non-hemorrhagic) 1 Unknown Ongoing*
Bleeding requiring transfusion 1 Unknown Resolved
Hematoma/Bleeding at access 2 1 Unknown; 1 Yes Resolved
Hemolytic Anemia 1 Unknown Resolved
Hyperbilirubinemia 1 Yes Resolved
Leg Pain during procedure 1 Yes Resolved
Select from these topics
Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
PEARL Comparison Treatment of Lower Extremity DVT
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
*Garcia et al. J Vasc Interv Radiol 2015; 26:777-785 † Mewissen MW, Seabrook GR. Radiology 1999:211:39-49
‡ Enden , Haig Y. Lancet 2012:379:31-38
CDT, catheter-directed thrombolysis; CFV, common femoral vein; LMWH, low molecular weight heparin; PMT, pharmacomechanical thrombolysis
Results from different trials are not directly comparable. Information provided for educational purposes only.
PEARL* Venous Registry† CDT Standard
# of Patients 329 287 90 99
# of Sites 32 63 20
Prior DVT 40% 31% 10% 9%
Primary Treatment Angiojet™ Thrombectomy With or without PMT CDT CDT LMWH
Stent Placement 35% 33% 17% NA
Primary access Popliteal Popliteal Popliteal NA
Male 57% 48% 64% 62%
Age (mean) 52.2 yrs 47.5 yrs 53.3 yrs 50.0 yrs
Treatment Location Iliofemoral - femoral pop Iliofemoral - femoral pop CFV or iliofemoral
Limbs involved Left=62%; Right=38% Left=61%; Right=39% Left=60%; Right=40% Left=62%; Right=38%
CaVent‡
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Select from these topics
Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
PEARL Comparison Treatment of Lower Extremity DVT
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
*Garcia et al. J Vasc Interv Radiol 2015; 26:777-785 †Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 ‡Enden , Haig Y. Lancet 2012:379:31-38
CDT, catheter-directed thrombolysis; PMT, pharmacomechanical thrombolysis; PPS, power-pulse spray; RL, rheolytic; TPA, tissue plasminogen activator
Results from different trials are not directly comparable. Information provided for educational purposes only.
PEARL* Venous Registry† CDT Standard
Onsetof DVT
Symptoms
Acute 67% (≤14 days) 66% (≤10 days) 100% ≤21 days
Chronic 33% (>14 days) 16% (>10 days) NA
Acute & Chronic NA 19% NA
Primary Lytic TPA Urokinase TPA NA
CDT Drip Times (mean) 17 hrs 48 hrs 57.6 hrs (2.4 days) NA
ProcedureTimes
CDT (N=29) 40.9 hrs NA NA NA
CDT+PPS/RL(N=172) 22.0 hrs NA NA NA
PPS/RL (N=115) 2.0 hrs NA NA NA
Bleeding Complications 4.5% (major & minor combined)
11% (major);16% (minor)
22% (major & minor combined) 0%
CaVent‡
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Overview
Venous (DVT) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Results Venographic Results Maintained Benefits Patient QOL DVT Events Study Comparisons
Limb Ischemia (LI)
AV Access (AV)
PEARL Comparison Treatment of Lower Extremity DVT
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
*Garcia et al. J Vasc Interv Radiol 2015; 26:777-785 †Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 ‡Enden , Haig Y. Lancet 2012:379:31-38
CDT, catheter-directed thrombolysis; PPS, power-pulse spray; RL, rheolytic
Results from different trials are not directly comparable. Information provided for educational purposes only.
PEARL* Venous Registry† CDT Standard
Overall % Thrombus Removal 96% 83% 89% NA
By Lytic Groups: %thrombusremoval
CDT (N=28) 93% NA NA
CDT+PPS/RL(N=167) 97% NA NA
PPS/RL(N=113) 95% NA NA
Acute: % Thrombus Removal 97% 86% 89%
Chronic: % Thrombus Removal 95% 68% NA
Primary Patency NA 6 Mon = 65%;12 Mon = 60% 6 Mon = 65.9% 6 Mon = 47.4%
Freedom from Rethrombosis
6 Mon = 87%;12 Mon = 83% NA NA NA
CaVent‡
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Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
LIMB ISCHEMIAPresented by Dr. Ali Amin at Charing Cross 2014
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Limb Ischemia Baseline Characteristics
Demographics/Risk Factors
Age (years) 65 (±13.0)
Gender (male) 248 (60%)
Hypertension 324 (79%)
Diabetes 139 (34%)
Hyperlipidemia 274 (67%)
CAD 183 (45%)
Smoking 153 (37%) current; 157 (38%) past
HX of Prior Interventions 270 (66%)
Amin. PEARL Registry Limb Ischemia. Charing Cross 2014
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Limb Ischemia: Clot Age by Onset
Amin. PEARL Registry Limb Ischemia. Charing Cross 2014
Time of Onset N(%)
≤ 24 Hours 86 (21%)
> 24 Hours and ≤ 7 Days 138 (34%)
> 7 Days and ≤ 14 Days 59 (14%)
> 14 Days and ≤ 30 Days 45 (11%)
> 30 days and ≤ 3 Months 55 (13%)
> 3 Months and ≤ 6 Months 14 (3%)
> 6 Months 13 (3%)
69% of patients report symptom onset of ≤ 14 days
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Limb Ischemia Technique Subgroups
CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysisAmin. PEARL Registry Limb Ischemia. Charing Cross 2014
Treatment Frequency
AngioJet Thrombectomy alone (no lytic) “Rheolytic”
77 (19%)
AngioJet + Lytic by AngioJet “PMT”
151 (37%)
AngioJet “Rheolytic” + CDT 116 (28%)
AngioJet “PMT” + CDT 66 (16%)
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Limb Ischemia Adjuvant Therapies
CDT, catheter-directed thrombolysisAmin. PEARL Registry Limb Ischemia. Charing Cross 2014
Therapy Frequency
Stent 220 (54%)
Balloon Angioplasty 308 (75%)
Catheter Directed Thrombolysis 182 (44%)
Other Thrombectomy 44 (11%)
Atherectomy 14 (3%)
No CDT needed– 226 (56%)
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Limb Ischemia Duration of Procedure N=397*
58% completed in ≤ 6 hours 80% completed in ≤ 24 hours
*(397/410 had times recorded) Amin. PEARL Registry Limb Ischemia. Charing Cross 2014
Time Period Frequency
6 Hrs 229 (58%)
> 6 Hrs & 12 Hrs 17 (4%)
> 12 Hrs & 24 Hrs 72 (18%)
>24 Hrs 79 (20%)
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Limb Ischemia Number of Lab Sessions N=406*
*(406/410 had # sessions recorded) Amin. PEARL Registry Limb Ischemia. Charing Cross 2014
86% had 2 or less sessions
Session = In and Out of Interventional Suite
# of Sessions N(%)
1 227 (56%)
2 121 (30%)
3 44 (11%)
>3 14 (3%)
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Limb Ischemia Renal Test Comparisons
Wilcoxon Signed Rank Test*Paired analysis
Amin. PEARL Registry Limb Ischemia. Charing Cross 2014
Analyte Pre-procedure
Mean
Post-procedure
Mean
Mean Difference*
PValue
BUN (N=263) 19.2 18.8 -0.4 0.0105
Creatinine (N=271) 1.4 1.4 0.0 0.5859
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Angiographic Results N=947 vessels treated (p<0.0001)
Amin. PEARL Registry Limb Ischemia. Charing Cross 2014
0 10 20 30 40 50 60 70 80 90
100
Improved Unchanged Worsened
93
6 <1
% o
f T
reat
ed V
esse
ls
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Angiographic Results by Technique Subgroups (p<0.0001)
CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysis
Amin. PEARL Registry Limb Ischemia. Charing Cross 2014
0 10 20 30 40 50 60 70 80 90
100
RheolyticThrombectomy
N=155
90
100
% o
f T
reat
ed V
esse
ls
PMTN=296
97
3 <1
PMT+ CDTN=325
94
6 <1
RheolyticThrombectomy
+CDTN=171
Improved
Unchanged
Worsened
89
11<1
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Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Angiographic Results clot age by symptom onset (p<0.0001)
Amin. PEARL Registry Limb Ischemia. Charing Cross 2014
0 10 20 30 40 50 60 70 80 90
100
% o
f T
reat
ed V
esse
ls
Chronic(>14 Days)
N=302
91
9<1
Acute(≤ 14 Days)
N=645
95
5 <1
Improved
Unchanged
Worsened
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
➦
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Limb Salvage Events
Amin. PEARL Registry Limb Ischemia. Charing Cross 2014ABI, ankle-brachial index
Events Patients
Discharge 3 Month 6 Month 12 Month N(%)
Amputation 16 12 3 4 33(8%) a
Bypass Graft 15 14 3 3 34(8%) b
Vascular Surgeries 22 2 1 0 25(6%) a2 patients had 2 amputations. b1 patient had 2 bypass grafts.
Mean ± SD (median); N=68; p<0.0001
Baseline Discharge Change in ABI
0.32 ± 0.26 (0.36) 0.84 ± 0.27 (0.92) 0.52 ± 0.37 (0.54)
ABI by paired analysis
Limb Salvage rate was 89% (185/207) for the acute limb ischemia patients with Baseline Rutherford classifications of IIa, IIb and III.
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Limb Ischemia Events
• All patients received dialysis. † Patient had a history of renal insufficiency. During hospitalization patient went into multi-organ failure resulting in death.‡ Patient was treated with hydration and antibiotics without sequelae
Amin. PEARL Registry Limb Ischemia. Charing Cross 2014
N Event Relationship to AngioJet Status
Arrhythmia 1 Unknown Resolved
Acute Renal Failure* 3 3 Unknown 2 Resolved; 1 treated†
Transient1 Renal Insufficiency 3 1 Yes; 2 Unknown Resolved
Bleeding requiring transfusion 7 7 Unknown Resolved
Hematoma/Bleeding at access 1 Yes Resolved
Pancreatitis‡ 1 Unknown Resolved
Hypotension 1 Unknown Resolved
Embolization 1 Unknown Resolved
Events where the AngioJet™ could not be ruled out as a contributing factor
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Patient Quality of Life Limb Ischemia SF 12 QOL (PEARL II Only)
There are statistically significant improvements measured by the physical (p<0.0001) and mental (p<0.0001) components. The pretreatment physical scores differ significantly from the 3, 6 & 12 month follow ups
QOL, quality of life
Amin. PEARL Registry Limb Ischemia. Charing Cross 2014
05
101520253035404550
6 MonthsN=182
QO
L M
ean
Sco
res
3 MonthsN=186
BaselineN=202
30.6
45.1
39.1
48.4
38.8
48.4
12 MonthsN=167
37.6
48.9Physical
Mental
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
Acute Limb Ischemia (ALI) Propensity Matched Analysis*
An initial analysis identified differences in the ALI PEARL patients between those that received CDT and those that did not. (ie, PMT with CDT vs PMT without CDT)
The key differences were observed in:
Infrapopliteal involvement
The Rutherford Classification
Amount of thrombus
Graft involvement
As a result of the differences, a propensity score was estimated using patient characteristics
The score was used to match patients in each group so a comparison on outcomes could be made “Apples to Apples”
The result was 86 matched patients in each group
*Leung et al. J Endovasc Ther 2015; in press.
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
➦MORE
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Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
ALI Propensity Matched Analysis* Procedure Characteristics
1 Fisher’s Exact test or Wilcoxon Rank Sum test* Leung et al. J Endovasc Ther 2015; in press.
# (%) or Mean ±SD (Median)
PMT with CDT N=86
PMT without CDT N=86 P-value1
Total Lytic Dose (mg) 28.6 ± 18.3 (25.3)
10.8 ± 11.1 (8.7) <0.0001
Procedure Length (hrs)
25.2 ± 14.5 (21.7)
2.2 ± 2.7 (1.8) <0.0001
AngioJet ™ delivery of lytic 55 (64%) 61 (71%) 0.4160
Stent and/or PTA Use 67 (78%) 79 (92%) 0.0179
Embolic Protection Use 7 (8%) 6 (7%) 1.0000
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
➦➦MORE
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
ALI Propensity Matched Analysis* Endpoints
Timepoint PMT with CDT N=86
PMT without CDT N=86
p-value1 (p-value2) (p-value3)
Procedure Success - 74% 88% 0.0214
(0.0233) (0.0208)
Amputation-free survival
6 Mon 12 Mon
77% 72%
90% 87%
0.0285 (0.0203) (0.0345)
Freedom from amputation
6 Mon 12 Mon
83% 81%
96% 96%
0.0098 (0.0125) (0.0155)
Freedom from mortality
6 Mon 12 Mon
94% 91%
93% 91%
0.9487 (0.9441) (0.9557)
Freedom from bleeding
6 Mon 12 Mon
90% 90%
93% 93%
0.5914 (0.5627) (0.5974)
Freedom from Renal failure
6 Mon 12 Mon
95% 95%
93% 93%
0.7145 (0.6858) (0.5383)
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
➦➦MORE
1 p-value for group comparison in logistic regression for procedure success and Cox proportional hazards regression for the remaining endpoints.2 p-value for group comparisons that account for matching on propensity score. McNemar’s test was used for procedure success and the robust
sandwich estimate for the standard error was used in the Cox proportional hazards regression models.3 p-value for group comparisions in statistical model including infrapopliteal involvement (y/n) and history of peripheral arterial disease (y/n).4 Bleeding requiring transfusion.*Leung et al. J Endovasc Ther 2015; in press.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI) Demographics Clot Age Treatment Subgroups Adjuvant Therapies Procedure Duration Number of Sessions Renal Test Comparisons Angiographic Results Limb Salvage Events Limb Ischemia Events Patient QOL ALI Propensity Matched Analysis
AV Access (AV)
ALI Propensity Matched Analysis* Conclusions Results support the use of PMT (AngioJet™) as a first line treatment for ALI
ALI propensity analysis showed high rates of limb salvage were achieved in endovascular treatments that included AngioJet thrombectomy
Adding PMT provides rapid reperfusion to the extremity, a reduced procedure time with an acceptable risk profile without compromising limb salvage*Leung et al. J Endovasc Ther 2015; in press.
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
➦
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
HEMODIALYSIS ACCESSPresented by Dr. Eugene Simoni at VEITH 2013
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Hemodialysis Access Baseline Characteristics
Simoni. PEARL Registry Hemodialysis Access. VEITH 2013
Demographics/Risk Factors
Age (years) 62 (±13.6)
Gender (male) 75 (52%)
Hypertension 82 (57%)
Diabetes 64 (44%)
Hyperlipidemia 44 (30%)
Coronary Artery Disease 45 (31%)
Smoking 17 (12%) current; 48 (33%) past
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Hemodialysis Access Clot Age by Onset
Simoni. PEARL Registry Hemodialysis Access. VEITH 2013
Time of Onset N(%)
24 Hours 76 (52%)
> 24 Hours and 7 Days 65 (45%)
> 7 Days and 14 Days 1 (<1%)
> 14 Days and 30 Days 1 (<1%)
> 30 days and 3 Months 2 (1%)
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Hemodialysis Access Technique Subgroups
CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysisSimoni. PEARL Registry Hemodialysis Access. VEITH 2013
Treatment Frequency
AngioJet Thrombectomy alone (no lytic) “Rheolytic”
125 (86%)
AngioJet + Lytic by AngioJet “PMT”
19 (13%)
AngioJet “Rheolytic” + CDT 1 (1%)
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Hemodialysis Access Adjuvant Therapies
Simoni. PEARL Registry Hemodialysis Access. VEITH 2013
Therapy Frequency
Balloon Angioplasty 128 (88%)
Stent 59 (41%)
Fogarty Balloon/ Manual Embolectomy 45 (31%)
Other Lytic 14 (10%)
Other Mechanical Thrombectomy 3 (2%)
Catheter Directed Thrombolysis 1(<1%)
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Hemodialysis Access Duration of Procedure
CDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysisSimoni. PEARL Registry Hemodialysis Access. VEITH 2013
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Overview
Venous (DVT)
Acute Limb Ischemia (ALI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency Median Procedure Time 1.30 hrs
Treatment Median Procedure Time
Rheolytic Thrombectomy alone 1.25 hrs
AngioJet™ + Lytic (PMT) 1.41 hrs
Rheolytic Thrombectomy + CDT 14.0 hrs
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
Angiographic Results N=186 vessels treated (p<0.0001)
Simoni. PEARL Registry Hemodialysis Access. VEITH 2013
0 10 20 30 40 50 60 70 80 90
100
Improved Unchanged Worsened
97
3 0
% o
f T
reat
ed V
esse
ls
➦➦MORE
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
➦➦MORECDT, catheter-directed thrombolysisPMT, pharmacomechanical thrombolysis Simoni. PEARL Registry Hemodialysis Access. VEITH 2013
0 10 20 30 40 50 60 70 80 90
100
RheolyticThrombectomy
N=162
98
2 0
% o
f T
reat
ed V
esse
ls
PMTN=23
100
0 0
RheolyticThrombectomy
+CDTN=171
Improved
Unchanged
Worsened
100
0 0
Angiographic Results by Treatment Groups (p<0.0001) N=186 vessels treated
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
➦aExcludes the vessels from one patient who had both an AV fistula and an AV graft but no follow up. Simoni. PEARL Registry Hemodialysis Access. VEITH 2013
0 10 20 30 40 50 60 70 80 90
100
GraftN=122
99
1 0
% o
f T
reat
ed V
esse
ls
FistulaN=61
97
3 0
UnkownN=1
100
0 0
Improved
Unchanged
Worsened
Angiographic Results by Access Type (p<0.0001) N=184a vessels treated
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
Simoni. PEARL Registry Hemodialysis Access. VEITH 2013
Hemodialysis Access Events
N Event Relationship to AngioJet
Status
Arrhythmia 2 2 Yes Resolved
Dissection of Vessel 1 Unknown Resolved
Events where the AngioJet™ could not be ruled out as a contributing factor
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
* Estimated by Kaplan Meier Simoni. PEARL Registry Hemodialysis Access. VEITH 2013
Maintained Graft/Fistula Survival
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
0 10 20 30 40 50 60 70 80 90
100
365 Days
% P
ts M
aint
aini
ng G
raft
183 Days91 Days
Days Post Procedure
96
80 76
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
* Estimated by Kaplan Meier Simoni. PEARL Registry Hemodialysis Access. VEITH 2013
Freedom from Rethrombosis / Restenosis with Intervention
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
0 10 20 30 40 50 60 70 80 90
100
365 Days
% P
ts F
ree
from
the
Even
t
180 Days90 Days
Days Post Procedure
83
53
37
Select from these topics
Overview
Venous (DVT)
Limb Ischemia (LI)
AV Access (AV) Demographics Clot Age Treatment Subgroups Adjunctive Therapies Procedure Duration Angiographic Results HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency
*Kakkos SK, Haddad GK, Haddad J, Scully MM. J Endovasc Ther. 2008;15(1):91-102. Simoni. PEARL Registry Hemodialysis Access. VEITH 2013. National Kidney Foundation Clinical Practice Guidelines and Recommendations; 2006. KDOQI, Kidney Disease Outcomes Quality Initiative
KDOQI: minimum goal for percutaneous thrombectomy is 40% unassisted patency and functionality at 3 months
Hemodialysis Access Overall Patency
0102030405060708090
100
6 Months
% P
atie
nt
Pat
ency
3 Months1 Month
7278
47 45
12 Months
31 30
PEARL
Henry Ford*
© 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
AngioJet™ Ultra Console
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. INTENDED USE/INDICATIONS FOR USE: The Console is intended for use only in conjunction with an AngioJet Ultra Thrombectomy Set. Refer to the individual Thrombectomy Set Information for Use manual for specific clinical applications. CONTRAINDICATIONS: Refer to the individual Thrombectomy Set Information for Use manual for specific contraindications. WARNINGS and PRECAUTIONS: Use the AngioJet Ultra Console only with an AngioJet Ultra Thrombectomy Set. This Console will not operate with a previous model pump set and catheter. • Do not attempt to bypass any of the Console safety features. • If the catheter is removed from the patient and/or is inoperative, the waste tubing lumen, guide catheter, and sheath should be flushed with sterile, heparinized solution to avoid thrombus formation and maintain lumen patency. Reprime the catheter by submerging the tip in sterile, heparinized solution and operating it for at least 20 seconds before reintroduction to the patient. • Refer to the individual AngioJet Ultra Thrombectomy Set Information for Use manual for specific warnings and precautions. • Do not move the collection bag during catheter operation as this may cause a collection bag error. • Monitor thrombotic debris/fluid flow exiting the catheter through the waste tubing during use. If blood is not visible during console activation, the catheter may be occlusive within the vessel or the outflow lumen may be blocked. • Ensure adequate patient anticoagulation to prevent thrombus formation in outflow lumen. • Refer to individual Thrombectomy Set Instructions for Use manual for specific instructions regarding heparinization of the Thrombectomy Set. • The Console contains no user-serviceable parts. Refer service to qualified personnel. • Removal of outer covers may result in electrical shock. • This device may cause electromagnetic interference with other devices when in use. Do not place Console near sensitive equipment when operating. • Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. • To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • Where the “Trapping Zone Hazard for Fingers” symbol is displayed on the console, there exists a risk of trapping or pinching fingers during operation and care must be exercised to avoid injury. • Do not reposition or push the console from any point other than the handle designed for that purpose. A condition of overbalance or tipping may ensue. • The AngioJet Ultra Console should not be used adjacent to or stacked with other equipment, and if adjacent or stacked use is necessary, the AngioJet Ultra Console should be observed to verify normal operation in the configuration in which it will be used. • Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT. • The use of accessories and cables other than those specified, with the exception of accessories and cables sold by Bayer HealthCare as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the Ultra Console. • MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding Electro-Magnetic Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in the tables provided in the IFU. Adverse Events: Refer to the individual Thrombectomy Set Information for Use manual for specific observed and/or potential adverse events.
AngioJet, Solent, AVX, Power Pulse and Cross-Stream are trademarks of Boston Scientific.
Peripheral Interventions300 Boston Scientific WayMarlborough, MA 01752-1234www.bostonscientific.com
To order product or for more informationcontact customer service at 1.888.272.1001.
© 2015 Boston Scientific Corporationor its affiliates. All rights reserved.
PI-315422-AA JUN2015 © 2015 Boston Scientific Corporation or its affiliates. All rights reserved.
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