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In.Pact Admiral DCB PERFORMANCE

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 5 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.

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 3 years. The greater the delta, the better the outcomes. 

IN.PACT SFA Trial
IN.PACT Admiral DCB‡2

Kaplan Meier chart comparing the 3 year primary patency of IN.PACT Admiral DCB and PTA.

LEVANT 2 Trial
Lutonix™* 035 DCB‡3

Kaplan Meier chart showing the 2 year primary patency of Lutonix DCB compared to PTA.

ILLUMENATE Pivotal Study
Stellarex™* DCB‡4

Kaplan Meier chart showing the 3 year primary patency of Stellarex DCB compared to PTA.

Ranger II SFA Global Study
Ranger™* DCB‡§5

RANGER II SFA Global Study results showing the primary patency of Ranger drug-coated balloon up to 365 days

CONSISTENCY

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


12-month Primary Patency in Long Lesions

Graph showing the competitive comparison of the primary patency in long lesions for IN.PACT Admiral DCB and Lutonix DCB. No data was available for Stellarex DCB and Ranger DCB.

Note: Provisional stent rate for IN.PACT Admiral is 42.5% and for Lutonix 65.2%.6,7


12-month Outcomes for Patency in In-stent Restenosis (ISR)

Graph showing the competitive comparison of the 12 month outcomes for primary patency in in-stent restenosis for IN.PACT Admiral DCB, Lutonix DCB and PTA. No data was available for Stellarex DCB and Ranger DCB.


JAPAN TRIAL 12-MONTH PRIMARY PATENCY

Graph showing the competitive comparison of the Japan Trial 12 month primary patency results for IN.PACT Admiral DCB, Lutonix DCB and PTA. No Japan RCT conducted for Stellarex DCB.


FEMALES 12-MONTH PRIMARY PATENCY

Graph showing the competitive comparison of the 12 month primary patency results for females with IN.PACT Admiral DCB, Lutonix DCB, PTA and Stellarex DCB. No gender analysis shared for Ranger DCB.

SAFETY

IN.PACT Admiral DCB is shown to be safe through 5 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 5 years12

15.9%

19.9%

Major amputation rate through 5 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 4 years1

13.0%

15.6%

Major amputation rate through 4 years

0.0%

0.7%

 

 

IN.PACT ADMIRAL
DCB

IN.PACT
SFA TRIAL

RANGER 
DCB
RANGER SFA II
TRIAL

Drug dose

 

3.5 
𝛍g/mm2

2.0 
𝛍g/mm2

Drug in tissue

 

180 days

60 days

Safety

All-cause mortality through 1 year13

1.9%

2.5%

Major amputation rate through 1 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.

A chart that highlights published data about clinical trials for IN.PACT Admiral DCB, Lutonix DCB, Stellarex DCB and Ranger DCB.
*

™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.

§

Ranger™* DCB is not approved for commercial use in the United States.

||

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 J, Schneider P, Jaff MR, et al. Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions. Circ Cardiovasc Interv. June 2019;12(6):e007702.

2

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.

3

Bard S. Data: LEVANT 2 Trial. Presented at SVS 2015; Chicago, IL.

4

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

5

Brodmann M. Data presented at LINC 2020; Leipzig, Germany.

6

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

7

Lutonix IFU: BAW1387400r5.

8

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.

9

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. 2018;25(1):109-117.

10

Bard Data: 1-year outcomes from the LEVANT Japan Trial. PMDA Website (http://www.pmda.go.jp/medical_devices/2017/M20170830001/780045000_22900BZX00252000_A100_1.pdf). (in Japanese) Accessed September 3, 2019.

11

Stellarex IFU No. P011966.

12

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

13

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. 2015;131(5):495-502.

14

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. 2015;66(21):2329-2338.

15

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. 2019;93(4):664-672.

16

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. 2019;73(20):2550-2563.

17

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. 2019;26(4):471-478.

18

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. 2019;12(1):e007730.

19

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.

20

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. 2016;9(22):2343-2352.

21

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. 2019;70(4):1177-1191.e9.

22

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. 2018;11(10):e005654.

23

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. 2019;12(5):484-493.

24

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. 2018;25(6):673-682.

25

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. 2019;26(3):305-315.

26

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

27

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. 2016;23(3):409-416.

28

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. 2014;7(1):10-19.

29

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. 2017;10(16):1682-1690.

30

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.

31

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. 2017;136(12):1102-1113.

32

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. 2017;135(23):2227-2236.

33

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. 2018;11(23):2357-2364.

34

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. 2015;86(2):278-286.

35

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.

36

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. 2018;91(3):497-504.

37

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.

38

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.