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Peripheral drug-coated balloons

IN.PACT™ Admiral™ and IN.PACT™ 018 drug-coated balloons

<p>The IN.PACT™ Admiral™ and IN.PACT™ 018 drug-coated balloons (DCB) are proven treatments for femoropopliteal disease.&nbsp;</p>

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Product details

This is an image of the IN.PACT™ Admiral™ or IN.PACT™ 018 drug-coated balloon.

IN.PACT™ Admiral™ DCB

  • Compatible with 0.035" guidewires
  • Tested and trusted, with more than 500,000 patients treated worldwide
  • Five years of efficacy and safety data,1 even in complex lesions2
  • Available in 200 mm and 250 mm balloon lengths
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The IN.PACT™ 018 drug-coated balloon (DCB) is a low-profile DCB designed to treat femoropopliteal disease.

IN.PACT™ 018 DCB

  • Compatible with 0.018" guidewires
  • Uses the same proven drug formulation as IN.PACT™ Admiral™ DCB
  • Low-profile design provides better deliverability†
  • 80 cm and 130 cm catheter lengths
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Proven formulation of paclitaxel in tissue

Only the IN.PACT™ Admiral™ and IN.PACT™ 018 DCBs release the drug into the tissue through the restenotic window.

Duration of paclitaxel in tissue‡

See a comparison of drug-coated balloon duration in tissue results, up to 180 days.

Clinical evidence

IN.PACT™ Admiral™ DCB has the:

  • Highest patency benefit through three years compared to PTA§1
  • Most publications for a DCB◊
View clinical evidence

The safety and effectiveness of the IN.PACT™ Admiral™ DCB (0.035 in guidewire compatible), as established in the clinical studies that were performed primarily via femoral access, can be considered supportive for the IN.PACT™ 018 DCB. The IN.PACT™ 018 DCB has not been evaluated in a clinical study.

How it works

Uniquely made to deliver unmatched results compared to PTA

IN.PACT™ DCBs are coated with a combination of paclitaxel and an excipient, urea. The unique formulation allows rapid and efficient delivery of drug to the vessel wall.

Watch a video to see how our DCBs work.

Specifications

Features IN.PACT™ Admiral DCB IN.PACT™ 018 DCB
Guidewire compatibility 0.035 in 0.018 in
Catheter design Over-the-wire (OTW) Over-the-wire (OTW)
Catheter lengths 80 and 130 cm 80 and 130 cm
Balloon diameters 4.0 to 7.0 mm 4.0 to 7.0 mm
Balloon lengths 40, 60, 80, 120, 150, 200, 250 mm 40, 60, 80, 100, 120, 150 mm
Balloon fold configurations 4.0 mm: 3 folds 5.0, 6.0, and 7.0 mm: 6 folds 4.0 mm: 3 folds 5.0, 6.0, and 7.0 mm: 6 folds
Paclitaxel drug dose 3.5 µg/mm2 3.5 µg/mm2
Excipient Urea Urea

Manuals and Technical Guides

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

Ordering information

IN.PACT 018 Paclitaxel-coated PTA Balloon Catheter

Shaft 80cm  Shaft 130cm  Balloon
diameter (mm)		 Balloon
length (mm)		 Recommended
Introducer Sheath (F)		 Nominal
pressure (atm)		 RBP (atm)
IPB04004008P IPB04004013P 4 40 5 8 10
IPB04006008P IPB04006013P 4        60 5       8       10
IPB04008008P IPB04008013P

4       

 80           5  8  10
IPB04010008P IPB04010013P 4                     100 5 8  10
IPB04012008P IPB04012013P

4                    

 120 5 8  10
IPB04015008P IPB04015013P

4             

 150 5 8 10
IPB05004008P IPB05004013P 5             40 5  8 10
IPB05006008P IPB05006013P

5          

 60 5  8  10
IPB05008008P IPB05008013P

5                   

 80 5 8 10
IPB05010008P IPB05010013P 5                100 5  8 10
IPB05012008P IPB05012013P

5              

 120 5 8 10
IPB05015008P IPB05015013P 5              150 5 8 10
IPB06004008P IPB06004013P

6             

 40 5 8 10
IPB06006008P IPB06006013P

6          

 60 5 8 10
IPB06008008P IPB06008013P 6               80    5 8 10
IPB06010008P IPB06010013P

6                   

 100 5 8 10
IPB06012008P IPB06012013P

6     

 120 5  8 10
IPB06015008P IPB06015013P 6          150 5 8  10
IPB07004008P IPB07004013P 7      40     6 8 10
IPB07006008P IPB07006013P

7             

 60 6 8 10
IPB07008008P IPB07008013P

7         

 80 6 8 10+

IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter

Ref. Number Usable
Length 40cm		 Ref. Number Usable
Length 80cm		 Ref. Number Usable
Length 130cm		 Balloon
Diameter (mm)		 Balloon
length(mm)		 Balloon
Recommended
sheath (F)		 RBP (atm)
SBI 040 040 04P SBI 040 040 08P  SBI 040 040 13P 4.0 40 5 14
SBI 040 060 04P SBI 040 060 08P  SBI 040 060 13P 4.0 60 5 14
SBI 040 080 04P SBI 040 080 08P  SBI 040 080 13P 4.0 80 5 14
- SBI 040 120 08P  SBI 040 120 13P 4.0 120 5 14
- SBI 040 150 08P  SBI 040 150 13P 4.0 150 5 14
- SBI04020008P  SBI04020013P 4.0 200 5 11
- SBI04025008P  SBI04025013P 4.0 250 5 11
SBI 050 040 04P SBI 050 040 08P  SBI 050 040 13P 5.0 40 6 14
SBI 050 060 04P SBI 050 060 08P  SBI 050 060 04P 5.0 60 6 14
SBI 050 080 04P SBI 050 080 08P SBI 050 080 13P 5.0 80 6 14
- SBI 050 120 08P  SBI 050 120 13P 5.0 120 6 14
- SBI 050 150 08P  SBI 050 150 13P 5.0 150 6 14
- SBI05020008P  SBI05020013P 5.0 200 6 11
- SBI05025008P  SBI05025013P 5.0 250 6 11
SBI 060 040 04P  SBI 060 040 08P  SBI 060 040 13P 6.0 40 6 14
SBI 060 060 04P  SBI 060 060 08P  SBI 060 060 13P 6.0 60 6 14
SBI 060 080 04P  SBI 060 080 08P  SBI 060 080 13P 6.0 80 6 14
-  SBI 060 120 08P  SBI 060 120 13P 6.0 120 6 14
-  SBI 060 150 08P  SBI 060 150 13P 6.0 150 6 14
-  SBI06020008P  SBI06020013P 6.0 200 6 11
-  SBI06025008P  SBI06025013P 6.0 250 6 11
SBI 070 040 04P SBI 070 040 08P  SBI 070 040 13P 7.0 40 7 14
SBI 070 060 04P SBI 070 060 08P  SBI 070 060 13P 7.0 60 7 14
SBI 070 080 04P SBI 070 080 08P  SBI 070 080 13P 7.0 80 7 14
SBI 080 040 04P SBI 080 040 08P  SBI 080 040 13P 8.0 40 7 10
SBI 080 060 04P SBI 080 060 08P  SBI 080 060 13P 8.0 60 7 10
SBI 080 080 04P SBI 080 080 08P  SBI 080 080 13P 8.0 80 7 10
SBI 090 040 04P SBI 090 040 08P  SBI 090 040 13P 9.0 40 7 10
SBI 090 060 04P SBI 090 060 08P  SBI 090 060 13P 9.0 60 7 10
SBI 090 080 04P SBI 090 080 08P  SBI 090 080 13P 9.0 80 7 10
SBI 100 040 04P SBI 100 040 08P  SBI 100 040 13P 10.0 40 7 9
SBI 120 040 04P  SBI 120 040 08P  SBI 120 040 13P 12.0 40 9  9

Related products

The safety and effectiveness of the IN.PACT Admiral DCB (0.035 in guidewire compatible), as established in the clinical studies that were performed primarily via femoral access, can be considered supportive for the IN.PACT 018 DCB. The IN.PACT 018 DCB has not been evaluated in a clinical study.

* Complications associated with radial access may include but are not limited to: abrupt vessel closure, vessel spasm, perforation or rupture of the artery, dissection, pseudoaneurysm, hematoma, thrombosis, and stroke.

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

† Data on file with Medtronic.

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

§ Primary patency not assessed after three years.

◊ List of publications on file with Medtronic.

¶ 120, 150, 200, and 250 mm lengths are not offered on the 7.0 mm diameter balloon.

  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. 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. PMA P140010: Summary of safety and effectiveness data. FDA. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p140010. Accessed September 26, 2022.
  4. PMA P190019: Summary of safety and effectiveness data. FDA. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190019. Accessed September 26, 2022.
  5. Yazdani SK, Pacheco E, Nakano M, et al. Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug-coated balloon in a swine femoral artery model. Catheter Cardiovasc Interv. 2014;83(1):132-140.
  6. PMA P160049: Summary of safety and effectiveness data. FDA. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160049. Accessed September 26, 2022.