luminor

Paclitaxel eluting PTA balloon dilatation catheter

LUMINOR-PORTADA-AZUL
LUMINOR-PORTADA-AZUL
Description

The paclitaxel-eluting balloon luminor, is a double lumen catheter from the connector to the tip (also called over-the-wire, OTW) designed for percutaneous transluminal angioplasties of large peripheral arteries.

The guidewire runs into the circular-largest lumen while the elliptic-smallest lumen is intended for contrast medium flow.

The maximum diameter of the guidewire must not exceed 0.89 mm = 0.035 inches.

On the catheter’s distal part, just before the tip, there is the balloon (inflatable segment) that will dilate the artery upon inflating through the infusion of contrast fluid inside of it. The connector is Y-shaped and it has two entry ports:

· The straight port is intended for guidewire passage.
· The side port allows contrast medium flow to dilate the balloon

The balloon is coated with a homogeneous mixture of paclitaxel, a derivative of Taxol, and a physiologically innocuous matrix, the excipient. Drug’s dose is 3 µg/mm2 of balloon surface and it is intended to avoid cellular proliferation, consequently decreasing re-intervention rate.

The drug is released from the balloon by means of rapid inflation so that a high dose is released in a very short period of time. To assure a sufficient dosage of paclitaxel into the arterial wall, the inflation process must last from 30 seconds to 1 minute. Dilation of the lesion can be optimized by using longer inflation times at the operator’s discretion.

The balloon is designed to reach different diameters at different pressures, as predicted by the compliance curve included in the primary packaging.

Two radiopaque markers of Pt/Ir alloy are located at each end of the balloon to mark its length and help the user to see the catheter while navigating inside the patient.

At the distal end, there is the tip, made from a very soft polymer and rounded forming a non-traumatic shape to avoid damaging the arterial wall while navigating.

The shaft of the catheter is coated with a proprietary hydrophilic formula to minimize friction.

TransferTech

iVascular´s proprietary coating nanotechnology in which paclitaxel is used in a microcrystalline structure and, together with the excipient, is spread on the balloon by ultrasound spray pulse.

The balloon surface is covered with multiple and independent nanodrops layers.

Such unique and innovative technology, provides a flexible coating, adapting to the balloon movement.

Transfertech

luminor 14m

Indication:
Dilatation of stenosis in femoral, popliteal and infra-popliteal arteries, with a nominal diameter from 1.5 mm to 4.0 mm and lengths from 40 mm up to 200 mm.
References luminor 14m

Specifications

· Catheter materials: Nylon/Pebax (it doesn’t contains latex components)
· Drug: 3 µg/mm2 paclitaxel
· Excipient: Organic ester. Lipophilic, biocompatible and biodegradable
· Balloon: Semi-compliant (10-15% from nominal pressure to RBP)
· Nominal Pressure: 7atm
· RBP: 16 atm
· ABP: 22 atm
· Recommended guidewire: 0.014″
· Crossing profile: from 0.026” up to 0.042”
· Tip profile: 0.017”
· Introducer compatibility: 4F for all diameters
· Deflation time: < 5s
· Usable catheter lengths: 100 cm and 150 cm

luminor 18

Indication:
Dilatation of stenosis in iliac, femoral, iliofemoral, popliteal, infra-popliteal 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 2 to 8 mm and lengths from 20 to 200 mm. It is also indicated for stent post-dilation in the peripheral vascular system.
References luminor 18

Specifications

· Catheter materials: Nylon/Pebax (it doesn’t contains latex components)
· Drug: 3 µg/mm2 paclitaxel
· Excipient: Organic ester. Lipophilic, biocompatible and biodegradable
· Balloon: Semi-compliant (10-15% from nominal pressure to RBP)
· Nominal Pressure: 7 atm
· RBP: 16 atm
· ABP: 20 atm
· Recommended guidewire: 0.018″ (0.014″ compatible)
· Crossing profile: from 0.035″ up to 0.063″
· Tip profile: 0.019” maximum
· Introducer compatibility: 4F (d: 2 – 5 mm) |5F (d: 6 – 8 mm)
· Deflation time: < 8s
· Usable catheter lengths: 100 cm, 140 cm and 150 cm

luminor 35

Indication:
The device is indicated for dilation of stenosis located in 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 post-dilation in the peripheral vascular system
References luminor 35

Specifications

· Catheter materials: Nylon/Pebax (the product doesn’t contain latex components)
· Drug: 3 µg/mm2 paclitaxel
· Excipient: Organic ester. Lipophilic, biocompatible and biodegradable
· Balloon: Semi-compliant (10-15% from nominal pressure to RBP)
· Nominal Pressure: 6/7 atm
· RBP: 16 atm
· ABP: 23 atm
· Recommended guidewire: 0.035”
· Crossing profile from 0.065” up to 0.077”
· Tip profile: 0.036”
· Introducer compatibility: 5F (d=5mm), 6F (d=6mm, d=7mm)
· Deflation time: < 5s
· Usable catheter lengths: 80 cm and 140 cm

Clinical support

luminor has proven its safety and efficacy in the following clinical trials and registries

LUMINOR Registry
MERLION Trial
EFFPAC Trial
BIBLIOS Trial
TINTIN Trial

Download Documents

Brochure luminor 14m
Brochure luminor 18
Brochure luminor 35

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