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Clinical Review

Clinical Review

A clinical review of
drug-coated balloons (DCB)

The IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter provides unparalleled effectiveness and safety, with 75% of patients re-intervention free at five years.1

Alert Indications, Safety, and Warnings

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™ Paclitaxel-coated PTA Balloon Catheter has the highest patency benefit and sustained delta through three years.

IN.PACT SFA Trial

IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter†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

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Consistency in outcomes

IN.PACT™ Admiral™ Paclitaxel-coated PTA Balloon Catheter 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

Explore the data (opens new window)

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

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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

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Additional resources

Related pages

Related products

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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: . (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.