A clinical review of
drug-coated balloons (DCB)

The IN.PACT™ Admiral™ Drug-Coated Balloon* provides unparalleled effectiveness and safety, with 75% of patients re-intervention free at five years.1

Overview

Data comes from different individual studies and may differ in a head-to-head comparison, and therefore may not be predictive of clinical results.

Highest patency benefit versus PTA

When comparing long-term durability of DCBs to PTA, IN.PACT™ Admiral™ Drug-Coated Balloon* has the highest patency benefit and sustained delta through three years.

IN.PACT SFA Trial

IN.PACT™ Admiral™ DCB*†3
Chart showing IN.PACT Admiral DCB patency results at three years compared to PTA

ILLUMENATE PIVOTAL Study

STELLAREX™* DCB†4,5
Chart showing Stellarex DCB patency results at three years compared to PTA

LEVANT 2 Trial

LUTONIX™* 035 DCB†6
Chart showing Lutonix DCB patency results at two years compared to PTA

RANGER II SFA Global Study

RANGER™* DCB†7,8
Chart showing Ranger DCB patency results at two years compared to PTA

Consistency in outcomes

IN.PACT™ Admiral™ Drug-Coated Balloon* demonstrates consistent performance across lesion complexity and patient diversity.

IN.PACT Global pre-specified cohorts: freedom from CD-TLR through five years2

de novo ISR

Chart showing the IN.PACT Global Study de novo ISR cohorts results for freedom from CD-TLR through five years

Long lesion

Chart showing the IN.PACT Global Study long lesions ISR cohorts results for freedom from CD-TLR through five years

CTO

Chart showing the IN.PACT Global Study CTO cohort results for freedom from CD-TLR through five years

IN.PACT global full cohort five-year freedom from CD-TLR rate: 69.4%2

12-month primary patency in long lesions

IN.PACT Global Study and Bard European study comparing patency between IN.PACT Admiral and Lutonix in long complex lesions

Note: Provisional stent rate for IN.PACT Admiral is 42.5% and is for Lutonix 65.2%.9,13

12-month primary patency in in-stent restenosis (ISR)

IN.PACT SFA Study looking at primary patency between IN.PACT Admiral and Lutonix in in-stent restenosis

Japan Trial 12-month primary patency

Japan Trial data in a bar chart format comparing primary patency between PTA and IN.PACT Admiral and Lutonix

Females 12-month primary patency

Bar chart comparing primary patency between PTA and IN.PACT Admiral, Lutonix, and Stellarex

Clinical evidence

Published data from the IN.PACT trials demonstrates our commitment to clinical evidence.

Chart showing the published studies for each drug-coated balloon and the number of years the research results reflect

Additional resources

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*

™Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. The approved product name for the drug-coated balloon is IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter.

Patency rates from clinical trials may be calculated differently. Chart is for illustrative purposes only and results may differ in head-to-head comparison, and therefore may not be predictive of clinical results.

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 Tepe G. 5-year results from the IN.PACT Global Study Prespecified Cohorts: ISR, CTO and Long Lesions. Presented at VIVA, 2021.
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):e005891.
4 Mathews SJ. 1- and 2-Year Outcomes. Presented at NCVH 2018. New Orleans, LA.
5 Mathews SJ. 3-Year Outcomes. Presented at NCVH 2019. New Orleans, LA.
6 Primary Patency is listed as reported in the IFU. Lutonix BAW1387400r9 Section 10.3.5 Table 7.
7 Brodmann M. 1 Year Outcomes. Presented at LINC 2020; Leipzig, Germany.
8 Sachar R. 2 Year Outcomes. Presented at VIVA 2020; Las Vegas, NV.
9 IN.PACT Admiral IFU M052624T001. Rev. 1G.
10 Lutonix IFU:BAW1387400r3, Primary patency per KM analysis at day 365.
11 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.
12 Lutonix IFU: BAW1387400r9.
13 Lutonix IFU BAW1387400r9 - Table 33: Procedural Data (Bailout Spot Stent used Post-DCB Dilatation, 65.2% (45/69).
14 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.
15 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 March 23, 2022.
16 Lutonix IFU: BAW1387400r5.
17 Stellarex IFU No. P011966.

DCB publication landscape
Medtronic IN.PACT Admiral DCB

18 Tepe G, et al. Circulation. 2015;131:495-502.
19 Iida O, et al. J Endovasc Ther. 2018;25:109-117.
20 Chen Z, et al. J Endovasc Ther. 2019;26:471-478.
21 Zeller T, et al. Circ Cardiovasc Interv. 2019;12:e007730.
22 Shishehbor MH, et al. J Vasc Surg. 2019;70:1177-1191.e9.
23 Kobe DS, et al. J Invasive Card. 2020;32:243-248.
24 Laird JR, et al. J Am Coll Cardiol. 2015;66:2329-2338.
25 Iida O, et al. Catheter Cardiovasc Interv. 2019;93:664-672.
26 Schneider PA, et al. Circ Cardiovasc Interv. 2018;11:e005891.
27 Soga Y, et al. J Endovasc Ther. 2020;27:946-955.
28 Laird JA, et al. Circ Cardiovasc Interv. 2019;12:e007702.
29 Schneider PA, et al. J Am Coll Cardiol. 2019;73:2550-2563.
30 Brodmann M, et al. JACC Cardiovasc Interv. 2017;10:2113-2123.
31 Scheinert D, et al. Circ Cardiovasc Interv. 2018;11:e005654.
32 Tepe G, et al. JACC Cardiovasc Interv. 2019;12:484-493.
33 Ansel GM, et al. J Endovasc Ther. 2018;25:673-682.
34 Reijnen MMPJ, et al. J Endovasc Ther. 2019;26:305-315.
35 Micari A, et al. JACC Cardiovasc Interv. 2018;11:945-953.
36 Salisbury AC, et al. JACC Cardiovasc Interv. 2016;9:2343-2352.
37 Pietzsch JB, et al. Cardiovasc Intervent Radiol. 2022;45:298-305.
38 Torsello G, et al. J Endovasc Ther. 2020;27:693-705.
39 Kohi M, et al. J Vasc Interv Radiol. 2020;31:1410-1418.e10.
40 Schneider PA, et al. Catheter Cardiovasc Interv. 2020;96:1087-1099.

BD Lutonix DCB
41 Rosenfield K, et al. N Engl J Med. 2015;373:145-153.
42 Scheinert D, et al. J Endovasc Ther. 2016;23:409-416.
43 Scheinert D, et al. JACC Cardiovasc Interv. 2014;7:10-19.
44 Thieme M, et al. JACC Cardiovasc Interv. 2017;10:1682-1690.
45 Ouriel K, et al. JACC Cardiovasc Interv. 2019;12:2515-2524.

Philips Stellarex DCB
46 Krishnan P, et al. Circulation. 2017;136:1102-1113.
47 Schroeder H, et al. Circulation. 2017;135:2227-2236.
48 Schroë H, et al. Catheter Cardiovasc Interv. 2018;91:497-504.
49 Brodmann M, et al. JACC Cardiovasc Interv. 2018;11:2357-2364.
50 Schroeder H, et al. Catheter Cardiovasc Interv. 2015;86:278-286.
51 Grey WA, et al. Circulation. 2019;140:1145-1155.
52 Lyden SP, et al. J Endovasc Ther. Published online January 8, 2022.
53 Lyden SP, et al. J Vasc Surg. 2022;75:600-607.

Boston Scientific Ranger DCB
54 Sachar R, et al. JACC Cardiovasc Interv. 2021;14:1123-1133.
55 Steiner S, et al. JACC Cardiovasc Interv. 2018;11:934-941.
56 Lichtenberg M, et al. J Cardiovasc Surg (Torino). 2018;59:45-50.
57 Steiner S, et al. Eur Heart J. 2020;41:2541-2552.