Essential

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.