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TransferTech coating technology

dual lumen

 

Nanotechnology drop dosage procedure that yields a multilayer thin coating.

Homogeneous and precise paclitaxel concentration of 3µg/mm2.

Transfertech coating technology has been engineered to improve clinical efficacy by optimizing coating properties and device functionalities.

Drug coating

doblado y replegado del balon

Improved mechanical properties provided by a multilayer coating that allows better adhesion to the balloon:

  • Minimizes consequences of handling.

  • Assures stability during trackability and prevents the release of particles.

 

Paclitaxel deposition in microcrystalline structure:

  • Excellent transfer of drug to the vessel wall.

  • Fast drug absorption: 30 – 60 s.

  • High drug retention time in the arterial wall.

 

Homogeneous and precise paclitaxel distribution for an effective treatment of the whole injury.

 

Device based on oceanus 14 balloon technology

Oceanus 14 balloon platform features:

doblado y replegado del balon

Low tip profile

Low tip profile and tip transition (0.016” / 0.026”) for a higher crossability

doblado y replegado del balon

Balanced transition

Segmented design optimized for excellent pushability and flexibility

doblado y replegado del balon

Tungsten-based polymeric radiopaque markers

Greater flexibility with the same visibility

Paclitaxel eluting balloon catheter has a rapid Exchange (RX) design, developed for dilatation by balloon of stenotic portions in coronary arteries or stenosis after bypass grafts which replace coronary arteries. Small vessels can also be treated, as well as residual stenosis after balloon treatment or endoprothesis, and also pre/post-dilatation of endovascular coronary prothesis, with the aim of improving myocardial perfusion. Specially designed for percutaneous transluminal angioplasty (PTA) of coronary arteries.

The catheter’s body has a configuration of simple proximal lumen and distal double lumen:

  • The simple lumen is constituted by a hypotube which provides high pushability and allows passage to the inflation liquid from the luer connector to the balloon

  • The double coaxial lumen has two functions:

    • Inner lumen for guide wire passage (máximum diameter 0.014”)

    • Outer inflation lumen with straight connection to the hypotube

     

The balloon or inflatable segment, of known diameter and length, is located at the distal end. It is also delimited by radiopaque markers and its tip is soft and non-traumatic.

The balloon is coated with the drug Paclitaxel; which is included in a physiologically innocuous matrix. Drug dose is 3 micrograms / mm2 of balloon surface and its purpose is to avoid cellular proliferation in order to lower re-intervention rate.

Drug release takes place by a fast inflation of the balloon so that a high dose of drug is eluted in a very short period of time. In order to assure drug release to the vessel wall, inflation duration must stay between 30 seconds and 1 minute, although dilatation of the injury can be optimized by longer inflation times at operator’s will.

The luer connector is settled at the proximal end. It allows connection to different accessories.

Catheter’s working length is 142 cm. The balloon is supplied in different lengths from 10 to 40 mm and diameters from 1.5 to 4.5 mm.

Preclinical efficacy

Essential yields 28-day restenosis that is statistically lower than the control and goes up to 23% less than competitors:

velocidad de desinflado

Prompt and sustained availability of paclitaxel in the arterial wall

velocidad de desinflado

Rapid release of paclitaxel with long term efficacy

Material

Nylon/Pebax. The product does not contain latex components.

 

Balloon coating

Paclitaxel eluting formulation, 3 µg/mm2

 

Balloon

Semi-compliant (10-15% of compliance from nominal pressure to RBP)

 

Nominal pressure

6 atm

 

Rated burst pressure (RBP)

16 atm

 

Average burst pressure (ABP)

20 atm

 

Balloon profile (crossing profile at maximum balloon length)

DIÁMETER INCHES =MM=FRENCH
1.5 0.026 = 0.67 = 2.0F
2 0.029 = 0.75 = 2.2F
2.5 0.032 = 0.83 = 2.5F
3 0.035 = 0.91 = 2.7F
3.5 0.038 = 0.99 = 3.0F
4 0.042 = 1.08 = 3.2F
4.5 0.041 = 1.05 = 3.1F

 

Radiopaque markers

2 polymeric markers based on tungsten with high flexibility

 

Dimensions

Working catheter length 142 cm
Catheter shaft 2F proximal
2.4 medium
2.2F distal
Entry profile 0.016 inches
Recommended guide wire 0.014 inches

 

Introducer compatibility

5F for all diameters
6F for kissing-balloon technique

 

Deflating rates

3 s average

 

Available diameters

1.5 a 4.5 mm

 

Available lengths

10 a 40 mm

 

References

dual lumen

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