Description

The Paclitaxel-eluting balloon “Luminor 14m” is a coaxial catheter (OTW, over-the-wire) designed for percutaneous transluminal angioplasties of small peripheral arteries.

The guidewire runs into the inner lumen while the outer lumen is intended for contrast medium flow. The maximum diameter of the guide wire must not exceed 0.36 mm = 0.014 inches.

On the catheter’s distal part, just before the tip, there is the balloon (inflatable segment) that will dilate the artery upon inflating by means of infusion of contrast fluid inside 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. The 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 a rapid inflation so that a high dose is released in a very short period of time. In order to assure a sufficient dosage of Paclitaxel onto the arterial wall, inflation process must last from 30 seconds to 1 minute. Dilation of the lesion can be optimized by using longer inflation times at operator’s discretion.

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

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

Indications

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.

Features

– iVascular’s proprietary coating technology “Transfertech”. Nanotechnology drop dosage system that yields a multilayer thin coating.

– Improved coating mechanical resistance. Better adhesion to the balloon
– Homogeneous and precise Paclitaxel concentration of 3 µg/mm2 on the balloon for an effective treatment of the whole injury

– Microcrystalline coating for faster drug absorption rate. Rapid release of Paclitaxel with long-term efficacy.

– Segmented catheter design for excellent pushability and trackability. Balanced transition of forces. Anti-kinking performance.
– 2 metallic radiopaque markers of Platinum / Iridium
– Very short balloon deflation rates.
– Wide balloon size range (200mm balloons)

Specifications

– Catheter materials: Nylon/Pebax (the product does not 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 Presure: 7 atm
– Rated Burst Pressure (RBP): 16 atm
– Average Burst Pressure (AVP): 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