essential

Paclitaxel-eluting coronary balloon dilatation catheter

ESSENTIAL
ESSENTIAL

Indications

Dilatation of stenotic portions in coronary arteries or stenosis after bypass grafts which replace coronary arteries. Small vessels can also be treated.
Residual stenosis after balloon treatment or endoprosthesis pre/post-dilatation of an endovascular coronary prosthesis, to improve myocardial perfusion.

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 Pressure: 6 atm
Rated Burst Pressure (RBP): 16 atm
Recommended guidewire: 0.014”
Tip profile: 0.016”
Introducer compatibility: 5F for all diameters (6F for kissing balloon technique)
Deflation time: 3s average
2 tungsten-based flexible polymeric radiopaque markers

Description

The paclitaxel-eluting balloon essential, is a rapid exchange catheter (also known as RX) designed for percutaneous transluminal angioplasties of coronary arteries.
The body of the catheter features a combination of a single lumen at the proximal end and a dual lumen at the distal end.
• The single lumen at the proximal end allows contrast liquid to pass through between the proximal luer-lock connector and the balloon during in/deflation.
• The coaxial dual lumen at the distal end has two functions: A lumen to carry the contrast liquid used to inflate the balloon, connected to the proximal lumen and a lumen for the guidewire to facilitate and allow the passage of the catheter towards and through the stenosis to be dilated.
The maximum diameter of the guidewire 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.
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 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, 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 discretion of the operator.
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.

Transfertech Logo

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

Clinical Support

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

ESSENTIAL in SV Registry
ESSENTIAL ISR

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