IN.PACT Admiral Interactive Scatter Plot iBrochure · 3 Zeller T, Peeters P, Bosiers M, et al....

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Femoropopliteal Artery Disease Clinical Data Landscape

Core Lab-adjudicated 12-month primary patency by Kaplan-Meier estimate of FDA-approvedClass III devices and their respective control arms, where applicable.

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IN.PACT™ Admiral™ DCB

KEY TAKEAWAY: Most PAD studies focus on short-term results for shorter lesions. Only IN.PACT Admiral drug-coated balloon shows consistently high patency in short and long lesions.

89.1% — the highest primary patency in long lesions at 12 months (28.7 cm).1-3

TURN OFF GROUPED OUTCOME

*ISR studies.** Subset analysis of previously reported data. IN.PACT Global Complex Lesion cohort consists of 227 subjects enrolled in the three IN.PACT Global

pre-specified imaging cohorts (long lesion, chronic total occlusion, and in-stent restenosis) exhibiting lesion lengths > 18 cm.1 IN.PACT™ Admiral™ DCB IFU M052624T001 Rev. 1H, Primary patency per KM analysis at day 360.2 Lutonix 035 DCB Instructions for Use BAW1387400r3 (2016).3 Zeller T, Peeters P, Bosiers M, et al. Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm

trial. J Endovasc Ther. December 2014;21(6):765-774.

Qualitative comparison for illustration purposes only. Not meant for head-to-head comparison.

Other DCB

PTA

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References

FAQ

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IN.PACT™ Admiral™ Drug-Coated Balloon

THINK LONG.

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*ISR studies.** Subset analysis of previously reported data. IN.PACT Global Complex Lesion cohort consists of 227 subjects enrolled in the three IN.PACT Global

pre-specified imaging cohorts (long lesion, chronic total occlusion, and in-stent restenosis) exhibiting lesion lengths > 18 cm.1 IN.PACT™ Admiral™ DCB IFU M052624T001 Rev. 1H, Primary patency per KM analysis at day 360.2 Lutonix 035 DCB Instructions for Use BAW1387400r3 (2016).3 Zeller T, Peeters P, Bosiers M, et al. Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm

trial. J Endovasc Ther. December 2014;21(6):765-774.

KEY TAKEAWAY: Most PAD studies focus on short-term results for shorter lesions. Only IN.PACT Admiral drug-coated balloon shows consistently high patency in short and long lesions.

89.1% — the highest primary patency in long lesions at 12 months (28.7 cm).1-3

VIEW GROUPED OUTCOME


Other DCB

PTA

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References

FAQ

Indications


THINK LONG.

GO THE DISTANCE.

*ISR studies.** Subset analysis of previously reported data. IN.PACT Global Complex Lesion cohort consists of 227 subjects enrolled in the

three IN.PACT Global pre-specified imaging cohorts (long lesion, chronic total occlusion, and in-stent restenosis) exhibiting lesion lengths > 18 cm.

KEY TAKEAWAY: Despite variations in studies, PTA consistently occupies the lowest patency.

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1 Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. January 18, 2005;45(2):312-315.

KEY TAKEAWAYS: BMS shows decreased

patency rate with increased lesion length.

Longer stent lengths are associated with higher fracture rates.1

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1 Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. January 18, 2005;45(2):312-315.




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BMS

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KEY TAKEAWAY: While stent grafts have some data for lesions longer than 15 cm, IN.PACT Admiral DCB demonstrates consistently high patency in short and long lesions without the need for full metal coverage.

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FAQ

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Stent Graft

THINK LONG.

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KEY TAKEAWAY: While stent graftshave some data forlesions longer than15 cm, IN.PACT AdmiralDCB demonstratesconsistently highpatency in short and longlesions without the needfor full metal coverage.

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Stent Graft

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KEY TAKEAWAYS: Other DCB data exist,

although the data are limited for lesions longer than 10 cm.

IN.PACT Admiral DCB shows consistent patency regardless of lesion complexity.

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KEY TAKEAWAYS: Other DCB data exist,



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*ISR studies. †Iida O, et al., report proportion-based patency of the ZEPHYR study.** Subset analysis of previously reported data. IN.PACT Global Complex Lesion cohort consists of 227 subjects enrolled in the


1 Phillips JA, Falls A, Kolluri R, et al. Full Drug-Eluting Stent Jacket: Two-Year Results of a Single-Center Experience With Zilver PTX Stenting for Long Lesions in the Femoropopliteal Arteries. J Endovasc Ther. June 2018;25(3):295-301.

KEY TAKEAWAYS: In short lesions, DES

patency rates are higher than PTA.

In longer lesions, few data are available. However, evidence exists that patency rates may be lower in longer lesions.1

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Click to Compare IN.PACT Admiral DCB to other therapies.IN.PACT™ Admiral™ Drug-Coated Balloon

Other DCB

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References

FAQ

Indications

Therapy vs. Therapy

IN.PACT Admiral DCB vs. PTA

IN.PACT Admiral DCB vs. DES

IN.PACT Admiral DCB vs. BMS

IN.PACT Admiral DCB vs. Other DCB

IN.PACT Admiral DCB vs. Stent Graft

THINK LONG.

GO THE DISTANCE.

Click to see comparisons of therapies vs. In.Pact AdmiralIN.PACT™ Admiral™ Drug-Coated Balloon

Other DCB

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References

FAQ

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PTA vs. IPA

DES vs. IPA

BMS vs. IPA

OTHER DCB vs. IPA

STENT GRAFT vs. IPA

Therapy vs. Therapy

Click to see comparisons of therapies vs. In.Pact Admiral

PTA vs. IPA

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*ISR studies.** Subset analysis of previously reported data. IN.PACT Global Complex Lesion cohort consists of 227 subjects enrolled in the three IN.PACT Global pre-specified imaging cohorts (long lesion, chronic

total occlusion, and in-stent restenosis) exhibiting lesion lengths > 18 cm.



THINK LONG.

GO THE DISTANCE.


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Indications

PTA vs. IPA

DES vs. IPA

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OTHER DCB vs. IPA

STENT GRAFT vs. IPA

Therapy vs. Therapy


PTA vs. IPA

DES vs. IPA

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total occlusion, and in-stent restenosis) exhibiting lesion lengths > 18 cm. 1 Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. January 18, 2005;45(2):312-315.





THINK LONG.

GO THE DISTANCE.


Other DCB

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References

FAQ

Indications

PTA vs. IPA

DES vs. IPA

BMS vs. IPA

OTHER DCB vs. IPA

STENT GRAFT vs. IPA

Therapy vs. Therapy


PTA vs. IPA

DES vs. IPA

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KEY TAKEAWAY: While stent grafts have some data for lesions longer than 15 cm, IN.PACT Admiral DCB demonstrates consistently high patency in short and long lesions without the need for full metal coverage.

THINK LONG.

GO THE DISTANCE.


Other DCB

PTA

DES

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References

FAQ

Indications

PTA vs. IPA

DES vs. IPA

BMS vs. IPA

OTHER DCB vs. IPA

STENT GRAFT vs. IPA

Therapy vs. Therapy

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Note:14: IN.PACT SFA RCT: IN.PACT Admiral DCB arm 15: IN.PACT Japan RCT: IN.PACT Admiral DCB arm 17: IN.PACT Global — ISR: IN.PACT Admiral DCB 19: IN.PACT Global — CTO: IN.PACT Admiral DCB 20: SFA-Long Study: IN.PACT Admiral DCB 21: IN.PACT Global — Long Lesion: IN.PACT Admiral DCB 22: IN.PACT Global — Complex Lesion post-hoc subset:

IN.PACT Admiral DCB 36: Zilver PTX RCT: Zilver PTX DES arm 37: IMPERIAL RCT: Zilver PTX DES arm 38: IMPERIAL RCT: Eluvia DES arm 39: IMPERIAL Long Lesion: Eluvia DES40: ZEPHYR: Zilver PTX DES

THINK LONG.

GO THE DISTANCE.


Other DCB

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References

FAQ

Indications

PTA vs. IPA

DES vs. IPA

BMS vs. IPA

OTHER DCB vs. IPA

STENT GRAFT vs. IPA

Therapy vs. Therapy


PTA vs. IPA

DES vs. IPA

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KEY TAKEAWAY: Other DCB data exist,



Note:10: LEVANT II RCT: Lutonix 035 DCB arm 11: ILLUMENATE EU RCT: Stellarex DCB arm 12: ILLUMENATE Global: Stellarex DCB 13: ILLUMENATE Pivotal RCT: Stellarex DCB arm14: IN.PACT SFA RCT: IN.PACT Admiral DCB arm 15: IN.PACT Japan RCT: IN.PACT Admiral DCB arm 17: IN.PACT Global — ISR: IN.PACT Admiral DCB 16: SFA ISR IDE RCT: Lutonix 035 DCB arm 18: Lutonix Long Lesion: Lutonix 035 DCB19: IN.PACT Global — CTO: IN.PACT Admiral DCB 20: SFA-Long Study: IN.PACT Admiral DCB 21: IN.PACT Global — Long Lesion: IN.PACT Admiral DCB 22: IN.PACT Global — Complex Lesion post-hoc subset:

IN.PACT Admiral DCB

THINK LONG.FREQUENTLY ASKED QUESTIONS

What vessel prep was used in the IN.PACT Admiral DCB studies? Only PTA was used for all the DCB studies (including IN.PACT Admiral DCB).

What were the provisional stent rates of the IN.PACT Admiral DCB groups?

What were the study inclusion criteria?In order to keep the data set more meaningful, only prospective core lab adjudicated studies with 12-month Kaplan-Meier PP are included. (Exception: Iida, et al. ZEPHYR Registry study reported proportion-based primary patency).1

What about long-term data for the IN.PACT Admiral DCB? Four-year data already published for the IN.PACT

SFA trial.2 Two-year data already published for the IN.PACT Global trial.3

Five-year data will be presented for the IN.PACT SFA trial at VIVA 2018. Three-year data was presented for the IN.PACT Global trial

at CIRSE 2018.4

Can study results be compared head-to-head in these charts?These charts are for illustration purposes only and not for head-to-head comparison of specific studies. See the reference list for patency definitions and study references for additional study details including study design, lesion characteristics, and patient demographics.

1 Iida O, Takahara M, Soga Y, et al. 1-Year Results of the ZEPHYR Registry (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery): Predictors of Restenosis. JACC Cardiovasc Interv. July 2015;8(8):1105-1112.

2 Schneider PA. Drug-coated Balloons Show Superior Four-Year Outcomes versus Angioplasty: Results from the IN.PACT SFA Randomized Trial (Abstract). Presented at VIVA 2017; Las Vegas, NV.

3 Micari A, Brodmann M, Keirse K, et al. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. May 28, 2018;11(10):945-953.

4 Tepe G. Three-year results from the IN.PACT Global Study. Presented at CIRSE 2018; Lisbon, Portugal.


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References

FAQ

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Therapy vs. Therapy

FAQ

Provisional Stenting Chart

Long-term Data Landscape

THINK LONG.

GO THE DISTANCE.


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References

FAQ

Indications

FAQ

PTA vs. IPA

DES vs. IPA

BMS vs. IPA

OTHER DCB vs. IPA

STENT GRAFT vs. IPA

Therapy vs.Therapy


PTA vs. IPA

DES vs. IPA

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OTHER DCB vs. IPA

STENT GRAFT vs. IPA

StudyPatency Definition

Provisional Stent Rate

IN.PACT SFA RCT: PTA arm5 PSVR ≤ 2.4 and freedom from CD-TLR 12.6%IN.PACT Japan RCT: PTA arm6 PSVR ≤ 2.4 and freedom from CD-TLR 3.0%IN.PACT SFA RCT: IN.PACT Admiral DCB arm14

PSVR ≤ 2.4 and freedom from CD-TLR 7.3%

IN.PACT Japan RCT: IN.PACT Admiral DCB arm15


IN.PACT Global — ISR: IN.PACT Admiral DCB17

PSVR ≤ 2.4 and freedom from TLR 14.5%

IN.PACT Global — CTO: IN.PACT Admiral DCB19


SFA-Long Study: IN.PACT Admiral DCB20

Freedom from > 50% restenosis and CD-TLR

10.5%

IN.PACT Global — Long Lesion: IN.PACT Admiral DCB21


IN.PACT Global — Complex Lesion post-hoc subset: IN.PACT Admiral DCB22


THINK LONG.

GO THE DISTANCE.


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Therapy vs. Therapy

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Medtronic IN.PACT™ Admiral™ DCB

1 year 2 years 3 years 4 years 5 years

IN.PACT SFA Trial ✓1, 2

✓1, 3

✓4

✓5

✓6

IN.PACT SFA Japan Trial ✓7

✓8

Phillips Stellarex™* DCB

Illumenate Pivotal ✓9

✓10

Illumenate EU RCT ✓11

✓12

BD Lutonix™* DCB

Levant II ✓13

✓14

Not reported Not reported Not reported

Levant Japan ✓15

Not reported

Cook Zilver™* PTX DES

Zilver PTX RCT ✓16

✓16

✓16

✓16

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Imperial RCT Control arm ✓

17

Boston Scientific Eluvia™* DES

Imperial RCT ✓17

LANDSCAPE OF LONG-TERM RCT DATA† FOR DCB AND DES SFA THERAPIES

1 IN.PACT Admiral Instructions for Use M052624T001 Rev 1H.2 Tepe G, et al. Circulation. 2015;131:495-502.3 Laird JR, et al. J Am Coll Cardiol. 2015;66:2329-2338.4 Schneider PA, et al. Circ Cardiovasc Interv. 2018;11:e005891.5 Schneider PA. IN.PACT SFA 4-Year Results. Presented at VIVA 2017; Las Vegas, NV.6 Laird JR. IN.PACT SFA 5-Year Results. Presented at VIVA 2018; Las Vegas, NV.7 Iida O, et al. J Endovasc Ther. 2018;25:109-117.8 Iida O. 2-year results from the MDT-2113 SFA Japan Trial – DCB vs. standard PTA for

the treatment of atherosclerotic lesions in the SFA/PPA. Presented at LINC 2018; Leipzig, Germany.

9 Krishnan P, et al. Circulation. 2017;136:1102-1113.

† Studies include only multicenter, core lab-adjudicated data from products that are commercially available in the United States.Qualitative comparison for illustration purposes only. Not meant for head-to-head comparison.

10 Mathews SJ. ILLUMENATE Pivotal 2-Year Results. Presented at NCVH 2018; New Orleans, LA.11 Schroeder H, et al. Circulation. 2017;135:2227-2236.12 Brodmann M. ILLUMENATE European Randomized Trial 2-Year Results. Presented at VIVA 2017; Las Vegas, NV.13 Rosenfield K, et al. N Engl J Med. 2015;373:145-153.14 Laurich C. LEVANT II 2-Year Results. Presented at SVS 2015; Chicago, IL.15 Bard Data: 1-year outcomes from the LEVANT Japan Trial. Available at: PMDA website (http://www.pmda.go.jp/medical_devices/

2017/M20170830001/780045000_22900BZX00252000_A100_1.pdf). Accessed October 29, 2018.16 Dake MD, et al. Circulation. 2016;133:1472-1483.17 Gray W, et al. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for

endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet. Published online September 24, 2018.

THINK LONG.

GO THE DISTANCE.

Scatterplot ReferencesFemoropoliteal artery disease — Clinical data landscape1 Dake M, Ansel GM, Jaff MR, et al. Paclitaxel-eluting stents show

superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. October 1, 2011;4(5):495-504.

2 Rosenfield K, Jaff MR, White CJ, et al. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. July 9, 2015;373(2):145-153.

3 Laird JR, Katzen BT, Scheinert D, et al. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. June 1, 2010;3(3):267-276.

4 Schroeder H, Werner M, Meyer DR, et al. Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon). Circulation. June 6, 2017;135(23):2227-2236.

5 IN.PACT Admiral DCB Instructions for Use. M052624T001 Rev. 1H. http://manuals.medtronic.com/manuals/main/en_US/home. Accessed September 28, 2018.

6 Iida O, Soga Y, Urasawa K, et al. Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial. J Endovasc Ther. February 2018;25(1):109-117.

7 Krishnan P, Faries P, Niazi K, et al. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation. September 19, 2017;136(12):1102-1113.

8 Bard Lutonix 035 DCB Instructions for Use. BAW1387400r3 (2016).9 Bosiers M, Deloose K, Callaert J, et al. Superiority of stent-grafts for

in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial. J Endovasc Ther. February 2015;22(1):1-10.

10 Rosenfield K, Jaff MR, White CJ, et al. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. July 9, 2015;373(2):145-153.

11 Schroeder H, Werner M, Meyer DR, et al. Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon). Circulation. June 6, 2017;135(23):2227-2236.

12 Schroë H, Holden AH, Goueffic Y, et al. Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study. Catheter Cardiovasc Interv. February 15, 2018;91(3):497-504.

13 Krishnan P, Faries P, Niazi K, et al. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation. September 19, 2017;136(12):1102-1113.


15 Iida O, Soga Y, Urasawa K, et al. Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial. J Endovasc Ther. February 2018;25(1):109-117.

16 Lutonix 035 DCB Instructions for Use. BAW1387400r3 (2016).

17 Brodmann M. Keirse K, Scheinert D, et al. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort. JACC Cardiovasc Interv. October 23, 2017;10(20):2113-2123.

18 Lutonix 035 DCB Instructions for Use. BAW1387400r3 (2016).19 Tepe G. IN.PACT Global – CTO: IN.PACT Admiral DCB - PSVR ≤ 2.4 and

freedom from CD-TLR. Presented at Charing Cross 2016; London, UK.20 Micari A, Vadala G, Castriota F, et al. 1-Year Results of Paclitaxel-Coated

Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study. JACC Cardiovasc Interv. May 9, 2016;9(9):950-956.

21 Scheinert D. IN.PACT Global – Long Lesion: IN.PACT Admiral DCB - PSVR ≤ 2.4 and freedom from CD-TLR. Presented at euroPCR 2015; Paris, France.


23 Complete SE stent Instructions for Use. M729425B001 Rev. 1B. http://manuals.medtronic.com/manuals/main/en_US/home. Accessed September 28, 2018.

24 Laird JR, Katzen BT, Scheinert D, et al. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. June 1, 2010;3(3):267-276.

25 Gray WA, Feiring A, Cioppi M, et al. S.M.A.R.T. self-expanding nitinol stent for the treatment of atherosclerotic lesions in the superficial femoral artery (STROLL): 1-year outcomes. J Vasc Interv Radiol. January 2015;26(1):21-28.

26 Garcia L, Jaff MR, Metzger C, et al. Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries: Twelve-Month Results of the SUPERB Trial. Circ Cardiovasc Interv. May 2015;8(5).

27 Duda SH, Bosiers M, Lammer J, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. December 2006;13(6):701-710.

28 Biotronik Astron Pulsar stent Instructions for Use. 364736/C/2016-07. https://manuals.biotronik.com/wps/portal/emanuals/emanual/ !ut/p/z1/hY5BC4JAFIR_iwevvreWId2WIFj1JpS9S2hsq7G6sm 7695PqEpTNbYZvmAGCAqgrx0aVrjFdqWd_os1ZhAxZimEaH8Q audjvkiyPWJ4yOD4B_CGOQP_6tIzgG1iYSICUNtXrLu-qVayAr LxKK21wt3NcO9cPWx99nKYpUMYoLYOLaX38VqnN4KD4JKFv C7xFesy45z0AYOgy3Q!!/dz/d5/L2dBISEvZ0FBIS9nQSEh/. Accessed September 28, 2018.

29 Ohki T, Angle JF, Yokoi H, et al. One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study). J Vasc Surg. February 2016;63(2):370-376.e1.

30 Boston Scientific Innova stent Instructions for Use. 90958202-01B (2015). http://www.bostonscientific.com/manuals/manuals/landing-page/US-english.html. Accessed September 28. 2018.

31 Laird JR, Zeller T, Loewe C, et al. Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial. J Endovasc Ther. February 2018;25(1):68-78.

32 Matsumura JS, Yamanouchi D, Goldstein JA, et al. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. July 2013;58(1):73-83.e1.

33 Laird JR, Zeller T, Loewe C, et al. Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial. J Endovasc Ther. February 2018;25(1):68-78.

34 Lammer J, Zeller T, Hausegger KA, et al. Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease). J Am Coll Cardiol. October 8, 2013;62(15):1320-1327.

35 Ansel G. VIBRANT RCT: BMS arm – PSVR < 2.5 and freedom from TLR. Presented at VIVA 2009; Las Vegas, NV, USA.

36 Dake M, Ansel GM, Jaff MR, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. October 1, 2011;4(5):495-504.

37 Gray W. Twelve-Month Results of the IMPERIAL Randomized TRIAL. Presented at TCT 2018; San Diego, CA.

38 Gray W. Twelve-Month Results of the IMPERIAL Randomized TRIAL. Presented at TCT 2018; San Diego, CA.

39 Gray W. IMPERIAL Long Lesion: Eluvia DES - PSVR ≤ 2.4 and FF CD-TLR. Presented at VIVA 2018; Las Vegas, NV, USA.

40 Iida O, Takahara M, Soga Y, et al. 1-Year Results of the ZEPHYR Registry (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery): Predictors of Restenosis. JACC Cardiovasc Interv. July 2015;8(8):1105-1112.

41 Bosiers M, Deloose K, Callaert J, et al. Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial. J Endovasc Ther. February 2015;22(1):1-10.

42 Ansel G. VIBRANT RCT: Viabahn stent-graft arm – PSVR < 2.5 and freedom TLR. Presented at VIVA 2009; Las Vegas, NV, USA.

43 Lammer J, Zeller T, Hausegger KA, et al. Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease). J Am Coll Cardiol. October 8, 2013;62(15):1320-1327.

44 Ohki T, Kichikawa K, Yokoi H, et al. Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions. J Vasc Surg. July 2017;66(1):130-142.e1.

45 Zeller T, Peeters P, Bosiers M, et al. Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm trial. J Endovasc Ther. December 2014;21(6):765-774.


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FOR UNITED STATES AUDIENCES ONLYINDICATIONS FOR USEThe IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.

CONTRAINDICATIONSThe IN.PACT Admiral DCB is contraindicated for use in: Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries Patients who cannot receive recommended antiplatelet and/or anticoagulant therapy Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper

placement of the delivery system Patients with known allergies or sensitivities to paclitaxel Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to

father children. It is unknown whether paclitaxel will be excreted in human milk and whether there is a potential for adverse reaction in nursing infants from paclitaxel exposure.

WARNINGS Use the product prior to the Use-by Date specified on the package. Contents are supplied sterile. Do not use the product if the inner packaging is damaged or opened. Do not use air or any gaseous medium to inflate the balloon. Use only the recommended inflation

medium (equal parts contrast medium and saline solution). Do not move the guidewire during inflation of the IN.PACT Admiral DCB. Do not exceed the rated burst pressure (RBP). The RBP is 14 atm (1419 kPa) for all balloons except the

200 and 250 mm balloons. For the 200 and 250 mm balloons the RBP is 11 atm (1115 kPa). The RBP is based on the results of invitro testing. Use of pressures higher than RBP may result in a ruptured balloon with possible intimal damage and dissection. The safety and effectiveness of using multiple IN.PACT Admiral DCBs with a total drug dosage

exceeding 34,854 µg of paclitaxel in a patient has not been clinically evaluated.

PRECAUTIONS This product should only be used by physicians trained in percutaneous transluminal angioplasty (PTA). This product is designed for single patient use only. Do not reuse, reprocess, or resterilize this product.

Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death. Assess risks and benefits before treating patients with a history of severe reaction to contrast agents. The safety and effectiveness of the IN.PACT Admiral DCB used in conjunction with other drug-eluting

stents or drug-coated balloons in the same procedure or following treatment failure has not been evaluated. The extent of the patient’s exposure to the drug coating is directly related to the number of balloons

used. Refer to the Instructions for Use (IFU) for details regarding the use of multiple balloons and paclitaxel content. The use of this product carries the risks associated with percutaneous transluminal angioplasty, including

thrombosis, vascular complications, and/or bleeding events. Vessel preparation using only pre-dilatation was studied in the clinical study. Other methods of vessel

preparation, such as atherectomy, have not been studied clinically with IN.PACT Admiral DCB. This product is not intended for the expansion or delivery of a stent.

POTENTIAL ADVERSE EFFECTSThe potential adverse effects (e.g., complications) associated with the use of the device are: abrupt vessel closure; access site pain; allergic reaction to contrast medium, antiplatelet therapy, or catheter system components (materials, drugs, and excipients); amputation/loss of limb; arrhythmias; arterial aneurysm; arterial thrombosis; arteriovenous (AV) fistula; death; dissection; embolization; fever; hematoma; hemorrhage; hypotension/hypertension; inflammation; ischemia or infarction of tissue/organ; local infection at access site; local or distal embolic events; perforation or rupture of the artery; pseudoaneurysm; renal insufficiency or failure; restenosis of the dilated artery; sepsis or systemic infection; shock; stroke; systemic embolization; vessel spasms or recoil; vessel trauma which requires surgical repair.

Potential complications of peripheral balloon catheterization include, but are not limited to the following: balloon rupture; detachment of a component of the balloon and/or catheter system; failure of the balloon to perform as intended; failure to cross the lesion.

Although systemic effects are not anticipated, potential adverse events that may be unique to the paclitaxel drug coating include, but are not limited to: allergic/immunologic reaction; alopecia; anemia; gastrointestinal symptoms; hematologic dyscrasia (including leucopenia, neutropenia, thrombocytopenia); hepatic enzyme changes; histologic changes in vessel wall, including inflammation, cellular damage, or necrosis; myalgia/arthralgia; myelosuppression; peripheral neuropathy.

Refer to the Physicians’ Desk Reference for more information on the potential adverse effects observed with paclitaxel. There may be other potential adverse effects that are unforeseen at this time.

Please reference appropriate product Instructions for Use for a detailed list of indications, warnings, precautions and potential adverse effects. This content is available electronically at www.manuals.medtronic.com.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

medtronic.com/SFAtherapy

Aortic | Peripheral | endoVenous3033 Campus Drive, N550Plymouth, MN 55441USA

OrdersTel: +1.763.514.8510Toll free: +1.800.716.6700Fax: +1.877.697.4841Email: [email protected]

CardioVascular LifeLineCustomer SupportTel: +1.763.526.7890Toll free: +1.877.526.7890

24-hour Technical SupportToll free: +1.800.328.2518

UC201905993a IE ©2019 Medtronic. All rights reserved. Medtronic and the Medtronic logo are trademarks of Medtronic. ™*Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. Not for distribution in France or Japan. 02/2019


Other DCB

PTA

DES

BMS

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Indications

Therapy vs. Therapy

FAQ

References

Indications

IN.PACT Admiral Interactive Scatter Plot iBrochure · 3 Zeller T, Peeters P, Bosiers M, et al....

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