Clinical Evidence

The IN.PACT™ Admiral™ DCB provides long-term effectiveness and safety, with 75% of patients re-intervention free at five years.¹

IN.PACT™ Admiral™ has demonstrated:

Highest patency benefit versus PTA
Consistency in outcomes
Extensive clinical evidence

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™ has the highest patency benefit and sustained delta through three years.

IN.PACT SFA trial

IN.PACT Admiral DCB^†,1

Illumenate pivotal study

Stellarex™* DCB^†,3,4

Ranger II SFA global study

Ranger™* DCB^†,5–7

Levant 2 trial

Lutonix™* 035 DCB^†,8

Consistency in outcomes

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

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

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

Explore the data (open in new window)

12-month primary patency in long lesions

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

Note: Provisional stent rate for IN.PACT Admiral is 42.5% and is for Lutonix 65.2%.^9,12

Japan Trial 12-month primary patency

Females 12-month primary patency

Clinical study primary safety endpoints

IN.PACT Global full cohort 5 years
IN.PACT SFA 12-month safety outcomes
IN.PACT SFA Japan 12-month safety outcomes

Major adverse events	48.5% (5891/1,215)
All-cause death	20.1% (244/1,215)
Major target limb amputation	1.6% (19/1,215)
Thrombosis	6.0% (73/1,215)

	DCB (N=220)	PTA (n=11)	PValue
30-day device and procedure-related death	0.0 (0/218)	0.0 (0/111)	>0.999
Target limb major amputation	0.0 (0/207)	0.0 (0/107)	>0.999
All-cause death	1.9 (4/207)	0.0 (0/107)	0.93
Thrombosis⁺	1.4 (3/207)	3.7 (4/107)	0.10

⁺ Defined as an occlusion attributable to thrombus formation that is rapidly evolving as confirmed by the sudden onset of symptoms within 14 days of imaging, and documented by duplex ultrasound and angiography of the index vessel.

Primary safety composite^†	65/68 (96)	26/32 (81)	0.028
30-day device and procedure-related death	0/68 (0)	0/32 (0)	—
Target limb major amputation	0/68 (0)	0/32 (0)	—
All-cause death	0/68 (0)	0/32 (0)	—
Thrombosis⁺	0/68 (0)	0/32 (0)	—

^†Defined as no 30-day device and procedure-related death, target limb major amputation, or CD-TVR through 12 months

Links to studies

IN.PACT SFA 1-year (Link: https://www.ncbi.nlm.nih.gov/pubmed/25472980)
- Tepe G, et al. Circulation. 2015;131:495-502.

IN.PACT SFA 2-year (Link: https://www.sciencedirect.com/science/article/pii/S0735109715066632?via%3Dihub)
- Laird J, et al. J Am Coll Cardiol. 2015;66:2329-2338.

IN.PACT SFA 3-year (Link: https://www.ncbi.nlm.nih.gov/pubmed/29326153)
- Schneider PA, et al. Circ Cardiovasc Interv. 2018;11:e005891.

IN.PACT SFA 5-year (link: https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.118.007702)
- Laird J, et al. Circ Cardiovasc Interv. 2019;12:e007702.

IN.PACT Japan 1-year (Link: https://www.ncbi.nlm.nih.gov/pubmed/29264999)
- Iida O, et al. J Endovasc Ther. 2018;25:109-117.

IN.PACT Japan 2-year (link: https://www.ncbi.nlm.nih.gov/pubmed/30747489)
- Iida O, et al. Catheter Cardiovasc Interv. 2019;93:664-672.

IN.PACT Japan 3-year (link: https://journals.sagepub.com/doi/full/10.1177/1526602820948240)
- Soga Y, et al. J Endovasc Ther. 2020:946–955.

Published data from industry-sponsored trials demonstrate our commitment to clinical evidence.

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

† 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.

IN.PACT™ Admiral drug-coated balloon

The IN.PACT™ Admiral™ DCB provides long-term effectiveness and safety, with 75% of patients re-intervention free at five years.¹