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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

Balanced transition

Segmented design optimized for excellent pushability and trackability.

doblado y replegado del balon

Short deflation rates

Thanks to the outstanding design of the catheter

doblado y replegado del balon

Tungsten-based polymeric radiopaque markers

Greater flexibility with the same visibility

Paclitaxel eluting balloon with coaxial design (OTW), intended for dilatation or opening of stenosis located at the femoral, popliteal and infrapopliteal arteries that appear with diameters between 1.5 and 4mm and longitudes between 40 and 200mm, through percutaneous transluminal angioplasty (PTA).

The catheter features two coaxial tubes throughout its length; it has a dual lumen from the proximal connection to the balloon. The inner lumen is for guide wire insertion (max. diameter 0.014’’) and leading to the lesion; while the outer lumen allows contrast liquid passage for balloon in-deflation and this it comprises the in-deflation channel.

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.

At both sides of the balloon there are tungsten-based radiopaque markers in order to limit its length and to help the user to know balloon position when it is inside the patient.

On the proximal part of the catheter, there is a hub comprising two ports; one for balloon in-deflation and another one for guide wire passage.

On the distal part there is the tip with rounded and non-traumatic shape in order to prevent harm to arteries during navigation.

Catheter’s working length is 100 cm or 150 cm depending on each reference.

The balloon is supplied in different lengths from 40 to 200 mm and diameters from 1.5 to 4 mm.

Preclinical efficacy

Luminor 14 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

7 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

 

Radiopaque markers

2 polymeric markers based on tungsten with high flexibility

 

Dimensions

Working catheter length 100 / 150 cm
Catheter shaft 3.9F proximal
2.9F distal
Entry profile 0.017 pulgadas
Recommended guide wire 0.014 pulgadas

 

Introducer compatibility

4F for all diameters

 

Deflating rates

Maximum 25s for all diameters and lengths

 

Available diameters

1.5 a 4 mm

 

Available lengths

40 a 200 mm

 

References

dual lumen

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