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Passeo®-14

A FAST DEFLATING PTA Balloon to treat long complex lower limb lesions

Indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.*

Category

Vascular Intervention Peripheral PVI Balloon Catheters

Product Highlights

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Up to 3.8 x faster deflation times¹

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Enhanced crossability

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High pushability and flexibility²

Up to 73% x faster deflation times¹

The coaxial catheter shaft design featuring large balloon inflation lumen to facilitate rapid inflation and deflation.

Passeo-14 balloon deflates

  • 73% faster than Amphirion Deep
  • 36% x faster than Coyote
  • 24% x faster than NanoCross
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Providing dedicated pedal design

  • ø 1.5 - 2.0 mm
  • 150 mm flexible distal shaft
  • Tailored stiffening wire

Enhanced crossability

The tri-fold balloon enables an enhanced crossability while minimizing slippage during inflation.

The balloon is fully coated with a hydrophilic coating when folded and only partly coated when inflated.

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High pushability and flexibility²

Different designs of the proximal and coaxial catheter shafts enable impressive pushability and high flexibility.

Impressive pushability due to catheter shaft design featuring a unique stiffening wire in the proximal shaft of the catheter, while enabling high flexibility due to a lower profile distal shaft in small, tortuous vessels.

Product Overview

Passeo-14

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Technical Data

Balloon catheter
Catheter type OTW
Recommended guide wire 0.014”
Tip Optimized entry profile and colored
Balloon material SCP (Semi-Crystalline Polymer), controlled compliance (4 - 6%)
Balloon folding 3-fold
Balloon coating Hydrophilic patchwork coating
Balloon markers 2 swaged markers (zero profile)
Sizes ø 1.5 - 4.0 mm; L: 20 - 220 mm
Distal shaft 3.1F, hydrophilic coating, coaxial design; 150 mm length (ø 1.5 /2.0 x 20 -

100 mm); 75 mm length (ø 2.0 x 140 - 220 mm and ø 2.5 - 4.0 mm)
Proximal shaft 3.9F, hydrophobic coating, coaxial design; stiffening wire
Usable length 150 cm (ø 1.5 - 4.0 mm); 120 cm (ø 1.5 - 2.0 mm); 90 cm (ø 2.5 - 4.0 mm)

Compliance Chart

    Balloon diameter x length (mm)
    ø 1.5 x 20-70 ø 2.0 x 40-220 ø 2.5 x 40-220 ø 3.0 x 40-220 ø 3.5 x 40-140 ø 4.0 x 40-140

Nominal Pressure [NP]

atm* 7 7 7 7 7 7


ø (mm)


1.5


2.0


2.5


3.0


3.5


4.0
Rated Burst Pressure [RBP] atm* 14 14 14 14 14 14


ø (mm)


1.57


2.08


2.61


3.18


3.63


4.16

Ordering Information

 

  Catheter cm
Length (mm)
Balloon
ø (mm)
Balloon Length (mm)
      20 40 70 100 140 180 220

4F

Antegrade Approach 

120 1.5 380271 380277 380283 - - - -
120 2 - 380278 380284 380290 380296 380302 380308
90 2.5 - 380279 380285 380291 380297 380303 380309
90 3 - 380280 380286 380292 380298 380304 380310
90 3.5 - 380281 380287 380293 380299 - -
90 4 - 380282 380288 380294 380300 - -
  Catheter cm
Length (mm)
Balloon
ø (mm)
Balloon
Length (mm)
      20 40 70 100 140 180 220

4F

Crossover Approach 

150 1.5 380313 380319 380325 - - - -
150 2 - 380320 380326 380332 380338 380344 380350
150 2.5 - 380321 380327 380333 380339 380345 380351
150 3 - 380322 380328 380334 380340 380346 380352
150 3.5 - 380323 380329 380335 380341 - -
150 4 - 380324 380330 380336 380342 - -
 

 

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References

*Indication as per IFU.

1. Measurements taken by IIB (Institut für Implant-Technologie und Biomaterialien) (Passeo-14 balloon 3 mm x 140 mm) and competitor devices (3 mm x 120 mm balloons), all with 150 cm usable catheter lengths. Data on file at BIOTRONIK. Bench test results not necessarily indicative of clinical performance; 2. Volume adjustment: A 3 mm x 120 mm contains 15% less contrast media volume than a 3 mm x 140 mm balloon. The measured deflation time of a 3 mm x 140 mm balloon was adjusted by 15% to make a direct competitive comparison; 3. BIOTRONIK data on file (IIB report 65/2012).

Passeo is a trademark or registered trademark of the BIOTRONIK Group of Companies.

Amphirion is a registered trademark of Invatec S.P.A. Armada is a registered trademark of Abbott Laboratories. Coyote is a registered trademark of Boston Scientific. NanoCross is a registered trademark of Covidien LP. Information on devices manufactured at companies other than BIOTRONIK was gathered from multiple sources. However it has not been verified by the vendors and we cannot guarantee its accuracy.