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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 35 balloon technology

Oceanus 35 balloon platform features::

doblado y replegado del balon

Short deflation rates

Thanks to the outstanding design of the catheter

doblado y replegado del balon

Double lumen tube with optimized design

Excellent pushability and trackability maximizing deflation rates

doblado y replegado del balon

Non-traumatic conical tip

Smooth finish for optimal crossing of severe injuries

Paclitaxel eluting balloon with coaxial design (OTW), intended for dilatation or opening of stenosis located at the iliac, femoral, ilio-femoral, popliteal, infrapopliteal and renal arteries as well as for the treatment of obstructive lesions of arteriovenous fistulas, whether original or artificial, with a reference diameter balloon from 5 to 7 mm and lengths from 20 to 150 mm. It is also indicated for stent postdilation in the peripheral vascular system. Specially designed for percutaneous transluminal angioplasty (PTA) technique.

The catheter features a dual lumen tube from the proximal connection to the balloon. One lumen is for guide wire (max. diameter 0.035”) insertion and catheter leading to the lesion; while the other one 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 radiopaque markers (platinum/iridium alloy) 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 80 cm or 140 cm depending on each reference.

The balloon is supplied in different lengths from 20 to 150 mm and diameters from 5 to 7 mm.

Preclinical efficacy

Luminor 35 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% of compliance from nominal pressure to RBP)

 

Nominal pressure

7 atm

 

Rated burst pressure (RBP)

16 atm

 

Balloon profile (crossing profile)

DIÁMETER INCHES =MM=FRENCH
5.0 0.065” = 1.65 mm = 4.9F
6.0 0.071” = 1.81 mm = 5.4F
7.0 0.077” = 1.97 mm = 5.9F

 

Radiopaque markersradiopacas

2 Platinum/Iridium markers embedded on the guiding lumen.

 

Dimensions

Working catheter length 80 / 140 cm
Catheter shaft 4F
Entry profile 0.037 pulgadas
Recommended guide wire 0.035 pulgadas

 

Introducer compatibility

Ø [mm]: 5.0 (hasta 80mm oflong) 5F
Ø [mm]: 6.0 – 7.0 6F

 

Deflating rates

Ø [mm]: 5 a 7 25s maximum

 

Available diameters

5 a 7 mm

 

Available lengths

20 a 150 mm

 

References

dual lumen

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