Performance IN.PACT™ Admiral™ Drug-Coated Balloon

A competitive comparison of DCBs

Overview

The optimal drug dose of the IN.PACT Admiral drug-coated balloon (DCB) provides unparalleled effectiveness and safety with 75% of patients re-intervention free at five years.1 This matters now more than ever.

Rates from independent clinical trials may be calculated differently; charts below are for illustrative purposes only and results may differ in head-to-head comparison.

IN.PACT Admiral drug-coated balloon on white background

Now Backed By 5-year  IDE and Global Study Data2

Durability 

When comparing long-term durability of DCBs, IN.PACT Admiral has the highest patency benefit and the highest sustained delta compared to PTA through three years. The greater the delta, the better the outcomes. 

IN.PACT SFA Trial
IN.PACT Admiral DCB‡3

Trial results show primary patency for IN.PACT Admiral with 87.5% at 360 days, 79.0% at 730 days, and 69.5% at 1,080 days

LEVANT 2 Trial
LUTONIX™* 035 DCB‡4

Trial results show primary patency for Lutonix 035 drug-coated balloon with 73.9% at 365 days and 58.9% at 730 days

ILLUMENATE
PIVOTAL Study
STELLAREX™* DCB‡5,6

Study results show primary patency of Stellarex DCB with 86.3% at 365 days, 72.1% at 730 days, and 64.2% at 1,095 days

RANGER II SFA
Global Study
RANGER™* DCB‡7

RANGER II SFA Global Study results showing the primary patency of Ranger drug-coated balloon with 89.8% at 365 days

Consistency

IN.PACT Admiral DCB demonstrates consistent performance across lesion complexity and patient diversity.

12-month Primary Patency in Long Lesions

12-month primary patency in long lesions for IN.PACT Admiral and Lutonix. No data available for Stellarex or Ranger

Note: Provisional stent rate for IN.PACT Admiral is 42.5% and for Lutonix 65.2%.4,8

12-month Primary Patency in In-stent Restenosis (ISR)

12-mo primary patency outcomes in in-stent restenosis for IN.PACT Admiral, Lutonix, and PTA. No data for Stellarex or Ranger

Japan Trial 12-month Primary Patency

Japan Trial 12-month primary patency results for IN.PACT Admiral, Lutonix, and PTA. No Japan RCT conducted for Stellarex DCB

Females 12-month Primary Patency

12-month primary patency results for females with IN.PACT Admiral, Lutonix, Stellarex, and PTA. No gender analysis for Ranger

Safety 

IN.PACT Admiral DCB is shown to be safe through five years.

 

IN.PACT ADMIRAL DCB
IN.PACT SFA TRIAL

LUTONIX DCB
LEVANT 2 TRIAL

Drug dose

3.5 𝛍g/mm2

2.0 𝛍g/mm2

Drug in tissue

180 days

30 days

Safety

All-cause mortality through five years13

15.9%

19.9%

Major amputation rate through five years

0.5%1

Data not shared.

 

IN.PACT ADMIRAL DCB
IN.PACT SFA TRIAL

STELLAREX DCB
ILLUMENATE PIVOTAL TRIAL

Drug dose

3.5 𝛍g/mm2

2.0 𝛍g/mm2

Drug in tissue

180 days

30 days

Safety

All-cause mortality through four years1

13.0%

15.6%

Major amputation rate through four years

0.0%

0.7%

 

IN.PACT ADMIRAL DCB
IN.PACT SFA TRIAL

STELLAREX DCB
ILLUMENATE PIVOTAL TRIAL

Drug dose

3.5 𝛍g/mm2

2.0 𝛍g/mm2

Drug in tissue

180 days

60 days

Safety

All-cause mortality through one year14

1.9%

2.5%

Major amputation rate through one year

0.0%

Data not shared.

Clinical Evidence 

Published data from the IN.PACT trials demonstrates our commitment to data transparency and reinforces the consistent performance of IN.PACT Admiral DCB.

Chart highlighting published data about clinical trials for IN.PACT Admiral DCB, Lutonix DCB, Stellarex DCB, and Ranger DCB

Additional Resources

Contact Us

CardioVascular LifeLine Customer Support

1-763-526-7890
rs.cstechsupport@medtronic.com

Orders

1-763-514-8510

24-hour Technical Support

1-763-514-4000
(Worldwide)
*

™Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

The potential for fewer visits to a healthcare provider may reduce exposure to COVID-19-related risks.

Patency rates from clinical trials may be calculated differently. Chart is for illustrative purposes only and results may differ in head-to-head comparison.

§

Primary patency is defined as freedom from CEC-adjudicated clinically driven TLR and from core lab-adjudicated binary restenosis. Patency per Kaplan-Meier estimates at 12 months (day 365).

||

Primary patency based on intent-to-treat (ITT) analysis. Primary patency is defined as freedom from clinically driven target lesion revascularization and freedom from restenosis as determined by duplex ultrasound-derived PSVR ≤ 2.4. Indication statement for IN.PACT Admiral (Japan): This device, IN.PACT Admiral Drug Coated Balloon Catheter, is indicated for percutaneous transluminal angioplasty of de novo and non-stented restenotic lesions with length ≤ 200 mm in superficial femoral and popliteal arteries with reference vessel diameters of ≥ 4 mm and ≤ 7 mm.

Primary patency based on intent-to-treat (ITT) analysis. Primary patency per Kaplan-Meier estimate is not available. Primary patency is defined as the absence of binary restenosis (as adjudicated by a blinded core lab) and freedom from target lesion revascularization. Indication statement for Lutonix (Japan): This device, Lutonix Drug-Coated Balloon Catheter, is indicated for treatment of de novo or restenotic lesion with a reference vessel diameter ≥ 4 mm and ≤ 6 mm and a length ≤ 15 cm in the native femoropopliteal artery (excluding in-stent lesion) to improve luminal diameter and to reduce restenosis.

References

1

Laird JA, Schneider PA, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. 5-year results from the IN.PACT SFA Trial. Circ Cardiovasc Interv. June 2019;12(6):e007702.

2

IN.PACT Global Study 5-year Outcomes Full Clinical Cohort. Zeller, T. VIVA 2020.

3

Schneider PA, Laird J, Tepe G, et al. Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial. Circ Cardiovasc Interv. January 2018;11(1):e.005891.

4

Lutonix IFU: BAW1387400r9.

5

Mathews SJ. Stellarex in the Treatment of the SFA and Popliteal: Late-Breaking 3-Year Data. Presented at NCVH 2019; New Orleans, LA.

6

Mathews S. ILLUMENATE IDE 2-Year Outcomes. Presented at NCVH 2018.

7

Brodmann M. Ranger II SFA 12-Months Outcomes. Presented at LINC 2020; Leipzig, Germany.

8

IN.PACT Admiral IFU M052624T001. Rev. 1G.

9

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.

10

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.

11

Bard Data: 1-year outcomes from the LEVANT Japan Trial. Pharmaceuticals and Medical Devices Agency. Available at: http://www.pmda.go.jp/medical_devices/2017/M20170830001/780045000_22900BZX00252000_A100_1.pdf. (in Japanese) Accessed September 3, 2019.

12

Stellarex IFU No. P011966.

13

FDA. Crude mortality rate from U.S. pivotal trials. Presented at FDA Circulatory System Devices Panel Meeting; June 19, 2019.

14

Tepe G, Laird J, Schneider P, et al. Drug-Coated Balloon Versus Standard Percutaneous Transluminal Angioplasty for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease: 12-Month Results from the IN.PACT SFA Randomized Trial. Circulation. February 2015;131(5):495-502.

15

Laird JR, Schneider PA, Tepe G, et al. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. December 2015;66(21):2329-2338.

16

Iida O, Soga Y, Urasawa K, et al. Drug-Coated Balloon Versus Uncoated Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan Randomized Trial. Catheter Cardiovasc Interv. March 2019;93(4):664-672.

17

Soga Y, Iida O, Urasawa K, et al. Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty. J Endovasc Ther. December 2020;27(6):946-955.

18

Schneider PA, Laird JR, Doros G, et al. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. May 2019;73(20):2550-2563.

19

Chen Z, Guo W, Jiang W, et al. IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population. J Endovasc Ther. August 2019;26(4):471-478.

20

Zeller T, Brodmann M, Micari A, et al. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain. Circ Cardiovasc Interv. January 2019;12(1):e007730.

21

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.

22

Salisbury AC, Li H, Vilain KR, et al. Cost-Effectiveness of Endovascular Femoropopliteal Intervention Using Drug-Coated Balloons Versus Standard Percutaneous Transluminal Angioplasty: Results From the IN.PACT SFA II Trial. JACC Cardiovasc Interv. November 2016;9(22):2343-2352.

23

Torsello G, Stavroulakis K, Brodmann M, et al. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. October 2020;27(5):693-705.

24

Kohi MP, Brodmann M, Zeller T, et al. Sex-Related Differences in the Long-Term Outcomes of Patients with Femoropopliteal Arterial Disease Treated with the IN.PACT Drug-Coated Balloon in the IN.PACT SFA Randomized Controlled Trial: A Post Hoc Analysis. J Vasc Interv Radiol. September 2020;31(9):1410-1418.e10.

25

Schneider PA, Brodmann M, Mauri L, et al. Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials. Catheter Cardiovasc Interv. November 2020;96(5):1087-1099. 

26

Shishehbor MH, Schneider PA, Zeller T, et al. Total IN.PACT Drug-Coated Balloon Initiative Reporting Pooled Imaging and Propensity-Matched Cohorts. J Vasc Surg. October 2019;70(4):1177-1191.e9.

27

Kobe DS, Jaff MR, Zeller T, Schneider PA, Shishehbor MH. Total IN.PACT All-Subjects One-Year Analysis and Standard vs Broader Implications. J Invasive Cardiol. July 2020;32(7):243-248. 

28

Scheinert D, Micari A, Brodmann M, et al. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The IN.PACT Global Study Long Lesion Imaging Cohort. Circ Cardiovasc Interv. October 2018;11(10):e005654.

29

Tepe G, Micari A, Keirse K, et al. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. March 2019;12(5):484-493.

30

Ansel GM, Brodmann M, Keirse K, et al. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded from Clinical Trials: 12-Month Findings from the IN.PACT Global Study. J Endovasc Ther. December 2018;25(6):673-682.

31

Reijnen MMPJ, van Wijck I, Zeller T, et al. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients with Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. June 2019;26(3):305-315.

32

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

33

Scheinert D, Schmidt A, Zeller T, et al. German Center Subanalysis of the LEVANT 2 Global Randomized Study of the Lutonix Drug-Coated Balloon in the Treatment of Femoropopliteal Occlusive Disease. J Endovasc Ther. June 2016;23(3):409-416.

34

Scheinert D, Duda S, Zeller T, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. January 2014;7(1):10-19.

35

Thieme M, Von Bilderling P, Paetzel C, et al. The 24-Month Results of the Lutonix Global SFA Registry: Worldwide Experience with Lutonix Drug-Coated Balloon. JACC Cardiovasc Interv. August 2017;10(16):1682-1690.

36

Ouriel K, Adelman MA, Rosenfield K, et al. Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC Cardiovasc Interv. December 23, 2019;12(24):2515-2524.

37

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 2017;136(12):1102-1113.

38

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 2017;135(23):2227-2236.

39

Brodmann M, Werner M, Meyer DR, et al. Sustainable Antirestenosis Effect with a Low-Dose Drug-Coated Balloon: The ILLUMENATE European Randomized Clinical Trial 2-Year Results. JACC Cardiovasc Interv. December 2018;11(23):2357-2364.

40

Schroeder H, Meyer DR, Lux B, Ruecker F, Martorana M, Duda S. Two-Year Results of a Low-Dose Drug-Coated Balloon for Revascularization of the Femoropopliteal Artery: Outcomes from the ILLUMENATE First-in-Human Study. Catheter Cardiovasc Interv. August 2015;86(2):278-286.

41

Gray WA, Jaff MR, Parikh SA, et al. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. October 2019;140(14):1145-1155.

42

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 2018;91(3):497-504.

43

Steiner S, Willfort-Ehringer A, Sievert H, et al. 12-Month Results From the First-in-Human Randomized Study of the Ranger Paclitaxel-Coated Balloon for Femoropopliteal Treatment. JACC Cardiovasc Interv. May 28, 2018;11(10):934-941.

44

Lichtenberg M, von Bilderling P, Ranft J, et al. Treatment of Femoropopliteal Atherosclerotic Lesions Using the Ranger Paclitaxel-Coated Balloon Catheter: 12-month Results From an All-Comers Registry. J Cardiovasc Surg (Torino). February 2018;59(1):45-50.

45

Steiner S, Schmidt A, Zeller T, et al. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J. July 14, 2020;41(27):2541-2552.