PEARL REGISTRY Post Market Registry

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1 PEARL REGISTRY Post Market Registry Real World Use of the AngioJet Thrombectomy System in the Peripheral Vascular System PI AA JUN2015

2 Objectives AngioJet Action Enrollment General Indications & Contraindications Two-phase, prospective, non-randomized multi-center registry PEARL I (January April 2010): Followed patients for 3 months with documentation of symptomatic improvement after rheolytic thrombectomy (with mid-length catheters) PEARL II (March 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

3 Objectives AngioJet Action Enrollment General Indications & Contraindications 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

4 Objectives AngioJet Action Enrollment General Indications & Contraindications 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.

5 Objectives AngioJet Action Enrollment General Indications & Contraindications Enrollment I N=952 patients 145 (15%) Hemodialysis Access (HA) 26 (3%) Other 371 (39%) Deep Venous Thrombosis (DVT) 410 (43%)

6 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons DEEP VEIN THROMBOSIS Presented by Dr. Mark Garcia at CIRSE 2013

7 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons DVT Baseline Characteristics /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

8 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons DVT Age by Onset Acute Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE Hours 18 (5%) > 24 Hours and 7 Days 158 (43%) > 7 Days and 14 Days 80 (22%) Sub Acute > 14 Days and 30 Days 68 (18%) Chronic > 30 days and 3 Months 33 (9%) > 3 Months and 6 Months 8 (2%) > 6 Months 6 (1%) 256/371 (69%) 68/371 (18%) 47/371 (13%) 69% of patients report symptom onset of 14 days

9 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons DVT Technique Subgroups Treatment AngioJet Thrombectomy alone (no lytic) Rheolytic AngioJet + Lytic by AngioJet PMT CDT, catheter-directed thrombolysis PMT, pharmacomechanical thrombolysis Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013 Frequency 20 (5%) 129 (35%) AngioJet Rheolytic + CDT 32 (9%) AngioJet PMT + CDT 190 (51%)

10 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons DVT 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%) CDT, catheter-directed thrombolysis. IVC, inferior vena cava. Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013 No CDT needed 149 (40%)

11 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons DVT Duration of Procedure N=355 * *(355/371 had times recorded) Time Period Frequency 6 Hrs 133 (38%) > 6 Hrs & 12 Hrs 37 (10%) > 12 Hrs & 24 Hrs 97 (27%) >24 Hrs 88 (25%) 38% completed in 6 hours 75% completed in 24 hours Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013

12 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons DVT Number of Lab Sessions N=359 * *(359/371 had # sessions recorded) # of Sessions N(%) (34%) (53%) 3 40 (11%) >3 7 (2%) 87% had 2 or less sessions Session = In and Out of Interventional Suite Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013

13 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons DVT Renal Test Comparisons Analyte Wilcoxon Signed Rank Test *Paired analysis Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013 Preprocedure Mean Postprocedure Mean Mean Difference* P Value BUN (N=235) Creatinine (N=239)

14 Venographic Results N=1295 vessels treated (p<0.0001) Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons % of Treated Vessels <1 Improved Unchanged Worsened Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013 MORE

15 Venographic Results by Technique Subgroups (p<0.0001) N=1295 vessels treated Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons % of Treated Vessels Rheolytic Thrombectomy N= PMT N= <1 PMT+ CDT N= <1 Rheolytic Thrombectomy +CDT N=111 Improved Unchanged Worsened CDT, catheter-directed thrombolysis PMT, pharmacomechanical thrombolysis Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013 MORE

16 Venographic Results clot age by symptom onset (p<0.0001) Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons % of Treated Vessels <= 24 Hrs N= <1 1-7 Days N= Days N=306 Improved Unchanged Worsened ACUTE DVT Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013 MORE

17 Venographic Results clot age by symptom onset (p<0.0001) Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons % of Treated Vessels Days N= Days N= >3 Months N=40 Improved Unchanged Worsened SUBACUTE CHRONIC Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013

18 Maintained Benefits DVT: Freedom from Rethrombosis Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons % Pts Free from Rethrombosis Days Days Days Days Post Procedure * Estimated by Kaplan Meier Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013 MORE

19 Maintained Benefits DVT: Maintained Clinical Benefit * Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons % Pts Maintaining Clinical Benefit Days Days Days Days Post Procedure * Estimated by Kaplan Meier Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013 MORE

20 Patient Quality of Life DVT: SF 12 QOL (PEARL II Only) Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons QOL Mean Scores Baseline N= Months N= Months N= Months N=151 Physical Mental 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 MORE

21 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons DVT Events Events where the AngioJet could not be ruled out as a contributing factor. Event N Relationship to 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 * Patient CVA, cerebrovascular accident; PE, pulmonary embolism Garcia. PEARL Registry Deep Vein Thrombosis. CIRSE 2013 MORE

22 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons PEARL Comparison Treatment of Lower Extremity DVT PEARL * Venous Registry CDT Standard # of Patients # of Sites Prior DVT 40% 31% 10% 9% Primary Treatment CaVent 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% * Garcia et al. J Vasc Interv Radiol 2015; 26: 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. MORE

23 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons PEARL Comparison Treatment of Lower Extremity DVT Onset of DVT Symptoms * Garcia et al. J Vasc Interv Radiol 2015; 26: Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 PEARL * Venous Registry CDT Standard 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 Procedure Times Bleeding Complications 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 4.5% (major & minor combined) 11% (major); 16% (minor) 22% (major & minor combined) CaVent 0% 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. MORE

24 Renal Results Venographic Results Maintained Benefits DVT Events Study Comparisons PEARL Comparison Treatment of Lower Extremity DVT Overall % Thrombus Removal By Lytic Groups: % thrombus removal Acute: % Thrombus Removal Chronic: % Thrombus Removal Primary Patency PEARL * Venous Registry CDT Standard 96% 83% 89% NA CDT (N=28) 93% NA NA CDT+PPS/RL (N=167) 97% NA NA PPS/RL (N=113) 95% NA NA 97% 86% 89% 95% 68% NA NA 6 Mon = 65%; 12 Mon = 60% CaVent 6 Mon = 65.9% 6 Mon = 47.4% Freedom from Rethrombosis 6 Mon = 87%; 12 Mon = 83% NA NA NA * Garcia et al. J Vasc Interv Radiol 2015; 26: 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. MORE

25 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis LIMB ISCHEMIA Presented by Dr. Ali Amin at Charing Cross 2014

26 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis Limb Ischemia Baseline Characteristics /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

27 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis Limb Ischemia: by Onset 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%) Amin. PEARL Registry Limb Ischemia. Charing Cross % of patients report symptom onset of 14 days

28 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis Limb Ischemia Technique Subgroups Treatment AngioJet Thrombectomy alone (no lytic) Rheolytic AngioJet + Lytic by AngioJet PMT CDT, catheter-directed thrombolysis PMT, pharmacomechanical thrombolysis Amin. PEARL Registry Limb Ischemia. Charing Cross 2014 Frequency 77 (19%) 151 (37%) AngioJet Rheolytic + CDT 116 (28%) AngioJet PMT + CDT 66 (16%)

29 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis Limb Ischemia Therapy CDT, catheter-directed thrombolysis Amin. PEARL Registry Limb Ischemia. Charing Cross 2014 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%)

30 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis Limb Ischemia Duration of Procedure N=397 * Time Period *(397/410 had times recorded) Amin. PEARL Registry Limb Ischemia. Charing Cross 2014 Frequency 6 Hrs 229 (58%) > 6 Hrs & 12 Hrs 17 (4%) > 12 Hrs & 24 Hrs 72 (18%) >24 Hrs 79 (20%) 58% completed in 6 hours 80% completed in 24 hours

31 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis Limb Ischemia Number of Lab Sessions N=406 * # of Sessions N(%) *(406/410 had # sessions recorded) Amin. PEARL Registry Limb Ischemia. Charing Cross (56%) (30%) 3 44 (11%) >3 14 (3%) 86% had 2 or less sessions Session = In and Out of Interventional Suite

32 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis Limb Ischemia Renal Test Comparisons Analyte Wilcoxon Signed Rank Test *Paired analysis Amin. PEARL Registry Limb Ischemia. Charing Cross 2014 Preprocedure Mean Postprocedure Mean Mean Difference* P Value BUN (N=263) Creatinine (N=271)

33 N=947 vessels treated (p<0.0001) Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis % of Treated Vessels <1 Improved Unchanged Worsened Amin. PEARL Registry Limb Ischemia. Charing Cross 2014 MORE

34 by Technique Subgroups (p<0.0001) Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis % of Treated Vessels Rheolytic Thrombectomy N= <1 PMT N= <1 PMT+ CDT N= <1 Rheolytic Thrombectomy +CDT N=171 Improved Unchanged Worsened CDT, catheter-directed thrombolysis PMT, pharmacomechanical thrombolysis Amin. PEARL Registry Limb Ischemia. Charing Cross 2014 MORE

35 clot age by symptom onset (p<0.0001) Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis % of Treated Vessels <1 Acute ( 14 Days) N= <1 Chronic (>14 Days) N=302 Improved Unchanged Worsened Amin. PEARL Registry Limb Ischemia. Charing Cross 2014

36 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis Limb Salvage Events Events Patients Discharge 3 Month 6 Month 12 Month N(%) Amputation (8%) a Bypass Graft (8%) b Vascular Surgeries (6%) a 2 patients had 2 amputations. b 1 patient had 2 bypass grafts. Limb Salvage rate was 89% (185/207) for the acute limb ischemia patients with Baseline Rutherford classifications of IIa, IIb and III. ABI by paired analysis Mean ± SD (median); N=68; p< Baseline Discharge Change in ABI 0.32 ± 0.26 (0.36) 0.84 ± 0.27 (0.92) 0.52 ± 0.37 (0.54) Amin. PEARL Registry Limb Ischemia. Charing Cross 2014 ABI, ankle-brachial index

37 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis Limb Ischemia Events Events where the AngioJet could not be ruled out as a contributing factor Event N Relationship to AngioJet Status Arrhythmia 1 Unknown Resolved Acute Renal Failure * 3 3 Unknown 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 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 Amin. PEARL Registry Limb Ischemia. Charing Cross 2014

38 Patient Quality of Life Limb Ischemia SF 12 QOL (PEARL II Only) Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis QOL Mean Scores Baseline N= Months N= Months N= Months N=167 Physical Mental 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

39 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis 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. MORE

40 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis ALI Propensity Matched Analysis * Procedure Characteristics # (%) or Mean ±SD (Median) Total Lytic Dose (mg) Procedure Length (hrs) 1 Fisher s Exact test or Wilcoxon Rank Sum test * Leung et al. J Endovasc Ther 2015; in press. PMT with CDT N= ± 18.3 (25.3) 25.2 ± 14.5 (21.7) PMT without CDT N= ± 11.1 (8.7) 2.2 ± 2.7 (1.8) P-value 1 < < AngioJet delivery of lytic 55 (64%) 61 (71%) Stent and/or PTA Use 67 (78%) 79 (92%) Embolic Protection Use 7 (8%) 6 (7%) MORE

41 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis ALI Propensity Matched Analysis * Endpoints Timepoint PMT with CDT N=86 PMT without CDT N=86 Procedure Success - 74% 88% Amputation-free survival Freedom from amputation Freedom from mortality Freedom from bleeding Freedom from Renal failure 6 Mon 12 Mon 6 Mon 12 Mon 6 Mon 12 Mon 6 Mon 12 Mon 6 Mon 12 Mon 77% 72% 83% 81% 94% 91% 90% 90% 95% 95% 90% 87% 96% 96% 93% 91% 93% 93% 93% 93% p-value 1 (p-value 2 ) (p-value 3 ) 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 (0.0233) (0.0208) (0.0203) (0.0345) (0.0125) (0.0155) (0.9441) (0.9557) (0.5627) (0.5974) (0.6858) (0.5383) MORE

42 Renal Test Comparisons Limb Salvage Events Limb Ischemia Events ALI Propensity Matched Analysis 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.

43 Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency HEMODIALYSIS ACCESS Presented by Dr. Eugene Simoni at VEITH 2013

44 Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency Hemodialysis Access Baseline Characteristics /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 Simoni. PEARL Registry Hemodialysis Access. VEITH 2013

45 Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency Hemodialysis Access by Onset 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%) Simoni. PEARL Registry Hemodialysis Access. VEITH 2013

46 Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency Hemodialysis Access Technique Subgroups Treatment AngioJet Thrombectomy alone (no lytic) Rheolytic AngioJet + Lytic by AngioJet PMT CDT, catheter-directed thrombolysis PMT, pharmacomechanical thrombolysis Simoni. PEARL Registry Hemodialysis Access. VEITH 2013 Frequency 125 (86%) 19 (13%) AngioJet Rheolytic + CDT 1 (1%)

47 Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency Hemodialysis Access 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%) Simoni. PEARL Registry Hemodialysis Access. VEITH 2013

48 Acute Limb Ischemia (ALI) Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency Hemodialysis Access Duration of Procedure Treatment Rheolytic Thrombectomy alone AngioJet + Lytic (PMT) Rheolytic Thrombectomy + CDT CDT, catheter-directed thrombolysis PMT, pharmacomechanical thrombolysis Simoni. PEARL Registry Hemodialysis Access. VEITH 2013 Median Procedure Time 1.30 hrs Median Procedure Time 1.25 hrs 1.41 hrs 14.0 hrs

49 N=186 vessels treated (p<0.0001) Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency % of Treated Vessels Improved Unchanged Worsened Simoni. PEARL Registry Hemodialysis Access. VEITH 2013 MORE

50 by Treatment Groups (p<0.0001) N=186 vessels treated Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency % of Treated Vessels Rheolytic Thrombectomy N= PMT N= Rheolytic Thrombectomy +CDT N=171 Improved Unchanged Worsened CDT, catheter-directed thrombolysis PMT, pharmacomechanical thrombolysis Simoni. PEARL Registry Hemodialysis Access. VEITH 2013 MORE

51 by Access Type (p<0.0001) N=184 a vessels treated Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency % of Treated Vessels Improved Unchanged Worsened Graft N=122 Fistula N=61 Unkown N=1 a Excludes 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

52 Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency Hemodialysis Access Events Events where the AngioJet could not be ruled out as a contributing factor Event N Simoni. PEARL Registry Hemodialysis Access. VEITH 2013 Relationship to AngioJet Status Arrhythmia 2 2 Yes Resolved Dissection of Vessel 1 Unknown Resolved

53 Maintained Graft/Fistula Survival Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency % Pts Maintaining Graft Days Days Days Post Procedure Days * Estimated by Kaplan Meier Simoni. PEARL Registry Hemodialysis Access. VEITH 2013

54 Freedom from Rethrombosis / Restenosis with Intervention 100 Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency * Estimated by Kaplan Meier Simoni. PEARL Registry Hemodialysis Access. VEITH 2013 % Pts Free from the Event Days Days Days Post Procedure Days

55 Hemodialysis Access Overall Patency KDOQI: minimum goal for percutaneous thrombectomy is 40% unassisted patency and functionality at 3 months Adjunctive Therapies HA Events Graft/Fistula Survival Freedom from Restenosis Overall Patency % Patient Patency PEARL Henry Ford* 0 1 Month 3 Months 6 Months 12 Months *Kakkos SK, Haddad GK, Haddad J, Scully MM. J Endovasc Ther. 2008;15(1): Simoni. PEARL Registry Hemodialysis Access. VEITH National Kidney Foundation Clinical Practice Guidelines and Recommendations; KDOQI, Kidney Disease Outcomes Quality Initiative

56 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 Interventions 300 Boston Scientific Way Marlborough, MA To order product or for more information contact customer service at Boston Scientific Corporation or its affiliates. All rights reserved. PI AA JUN2015

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