Healthcare Professionals

IN.PACT Admiral Drug-Coated Balloon

Paclitaxel Coated Balloon

Overview

Maintain long-term vessel patency with the IN.PACT™ Admiral™ drug-coated balloon (DCB), which provides durable, consistent, and safe outcomes across multiple clinical trials, as well as across complex patient and lesion types. With more than 3,500 patients enrolled in 21 clinical studies and 200,000+ patients treated, the IN.PACT Admiral balloon is the market-leading DCB for treatment of femoropopliteal disease with 75% of patients reintervention-free at 5 years.1This matters now more than ever.

IN.PACT SFA 5YEARS Outcomes

Indications

The IN.PACT Admiral is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including in-stent restenosis (ISR), and with obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Product Details

The IN.PACT Admiral DCB is a clinically proven, primary endovascular therapy that treats femoropopliteal disease, reduces interventions, and preserves future treatment options. 

IN.PACT Admiral DCB, with sustained drug release up to 180 days,2 has the:

  • Highest patency benefit through 3 years‡3
  • Lowest CD-TLR rates and lowest mortality through 5 years1,4
  • Most publications for a DCB§

HOW IT WORKS

DURATION OF PACLITAXEL IN TISSUE

Competitive comparison showing the duration of paclitaxel in tissue after an index procedure with IN.PACT Admiral DCB, Ranger DCB, Lutonix DCB and Stellarex DCB

Only the IN.PACT Admiral DCB releases drug into the tissue through the restenotic window.

IN.PACT Admiral Drug-Coated Balloon Mechanism of Action - (02:41)

DCB therapies have been around since 2001, when Dr. Bruno Scheller and Dr. Ulrich Speck envisioned combining mechanical dilatation from PTA with restenosis inhibition from a drug into a single device.

DCB: Decades of Development - (05:38)

Watch the evolution from concept into a frontline therapy for PAD.
More information (see more) Less information (see less)

MANUALS AND TECHNICAL GUIDES

Instructions for use.

Find this technical manual in the product labeling supplied with each device.

MODEL SPECIFICATIONS

TECHNICAL SPECIFICATIONS

Feature Specifications
Paclitaxel Drug Dose

3.5 µg/mm2

Excipient Urea
Balloon Diameters 4 mm to 12 mm
Balloon Lengths 40, 60, 80, 120, 150 mm*
Balloon Fold Configuration 4.0 mm: 3 folds; 5.0, 6.0, and 7.0 mm: 6 folds
Catheter Design Over the wire (OTW)
Catheter Lengths 40 cm, 80 cm and 130 cm
Guidewire Compatibility 0.035"
Nominal Balloon Pressure 8 atm

*120 mm and 150 mm lengths are not offered on the 7.0 mm diameter balloon.

ORDERING INFORMATION

IN.PACT™ Admiral™ Drug-Coated Balloon (0.035")

Ref. N°
Usable Length
40 cm
Ref. N°
Usable Length
80 cm
Ref. N°
Usable Length
130 cm
Balloon
Diameter
(mm)
Balloon
Length
(mm)
SBI 040 040 04P SBI 040 040 08P SBI 040 040 13P 4 40
SBI 040 060 04P SBI 040 060 08P SBI 040 060 13P 4 60
SBI 040 080 04P SBI 040 080 08P SBI 040 080 13P 4 80
- SBI 040 120 08P SBI 040 120 13P 4 120
- SBI 040 150 08P SBI 040 150 13P 4 150
SBI 050 040 04P SBI 050 040 08P SBI 050 040 13P 5 40
SBI 050 060 04P SBI 050 060 08P SBI 050 060 13P 5 60
SBI 050 080 04P SBI 050 080 08P SBI 050 080 13P 5 80
- SBI 050 120 08P SBI 050 120 13P 5 120
- SBI 050 150 08P SBI 050 150 13P 5 150
SBI 060 040 04P SBI 060 040 08P SBI 060 040 13P 6 40
SBI 060 060 04P SBI 060 060 08P SBI 060 060 13P 6 60
SBI 060 080 04P SBI 060 080 08P SBI 060 080 13P 6 80
- SBI 060 120 08P SBI 060 120 13P 6 120
- SBI 060 150 08P SBI 060 150 13P 6 150
SBI 070 040 04P SBI 070 040 08P SBI 070 040 13P 7 40
SBI 070 060 04P SBI 070 060 08P SBI 070 060 13P 7 60
SBI 070 080 04P SBI 070 080 08P SBI 070 080 13P 7 80
SBI 080 040 04P SBI 080 040 08P SBI 080 040 13P 8 40
SBI 080 060 04P SBI 080 060 08P SBI 080 060 13P 8 60
SBI 080 080 04P SBI 080 080 08P SBI 080 080 13P 8 80
SBI 090 040 04P SBI 090 040 08P SBI 090 040 13P 9 40
SBI 090 060 04P SBI 090 060 08P SBI 090 060 13P 9 60
SBI 090 080 04P SBI 090 080 08P SBI 090 080 13P 9 80
SBI 100 040 04P SBI 100 040 08P SBI 100 040 13P 10 40
SBI 120 040 04P SBI 120 040 08P SBI 120 040 13P 12 40

IN.PACT™ Pacific™ Drug-Eluting Balloon (0.018")

Ref. N° 
Usable Length 
90 cm
Ref. N° 
Usable Length 
130 cm
Balloon 
Diameter 
(mm)
Balloon 
Length 
(mm)
PCF 040 040 09P PCF 040 040 13P 4 40
PCF 040 060 09P PCF 040 060 13P 4 60
PCF 040 080 09P PCF 040 080 13P 4 80
PCF 040 120 09P PCF 040 120 13P 4 120
PCF 050 040 09P PCF 050 040 13P 5 40
PCF 050 060 09P PCF 050 060 13P 5 60
PCF 050 080 09P PCF 050 080 13P 5 80
PCF 050 120 09P PCF 050 120 13P 5 120
PCF 060 040 09P PCF 060 040 13P 6 40
PCF 060 060 09P PCF 060 060 13P 6 60
PCF 060 080 09P PCF 060 080 13P 6 80
PCF 060 120 09P PCF 060 120 13P 6 120
PCF 070 040 09P PCF 070 040 13P 7 40
PCF 070 060 09P PCF 070 060 13P 7 60
PCF 070 080 09P PCF 070 080 13P 7 80
PCF 070 120 09P PCF 070 120 13P 7 120

 

See product catalog for complete, detailed product information.

*™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.

‡Primary patency not assessed after 3 years.

§Data and additional comparative data on file with Medtronic.

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. Virmani R. Arterial wall response to drug coated balloon. Presented at Charing Cross 2016.
  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. Based on the mortality data from the LEVANT 2 IDE in the Lutonix™* DCB IFU (BAW1387400r6) and the IN.PACT SFA Trial in the IN.PACT™ Admiral™ DCB IFU (M052624T001).
  5. Gongora CA, Shibuya M, Wessler JD, et al. Impact of Paclitaxel Dose on Tissue Pharmacokinetics and Vascular Healing: A Comparative Drug-Coated Balloon Study in the Familial Hypercholesterolemic Swine Model of Superficial Femoral In-Stent Restenosis. JACC Cardiovasc Interv. July 2015;8(8):1115-1123.
  6. Spectranetics Stellarex 035 DCB Advisory Panel Briefing Package. June 2019