essential pro

the novel reliable DCB

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Indications

Dilatation of stenosis or coronary artery or bypass grafts occlusions, including small vessels, as well as for residual stenosis after treatment with balloon or endoprosthesis and pre- and post-dilation of coronary endovascular prosthesis, in order to improve myocardial perfusion.

Specifications

Rapid exchange catheter (RX)

Guide wire compatibility: max. 0.014”

2 distal shafts: 2.6F (Ø ≤ 3), 2.7F (Ø ≥ 3.25)

NP: 6 atm | RBP: 16 atm

2 Pt/Ir radiopaque markers

hydrophilic coating hydrax plus

Description

The paclitaxel eluting coronary balloon dilatation catheter is a rapid exchange catheter, also known as RX because it has a proximal simple lumen configuration and a distal coaxial dual lumen, intended for coronary arteries percutaneous transluminal angioplasties.

At the distal end of the catheter, before the tip, is the balloon or segment inflatable to different pressures which dilates the artery when inflated by means of an infusion of contrast liquid inside it. The balloon is designed to provide an inflatable segment of known diameter and length at the pressures recommended. The catheter ends in a cone-shaped tip.

The body of the catheter features a combination of a single lumen at the proximal end and dual lumen at the distal end.

The single lumen at the proximal end allows contrast liquid to pass through the proximal luer-lock connector and the balloon in order to inflate the balloon. This lumen is connected to the distal contrast liquid lumen at the end of the balloon.

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.

-The guide wire passes through the other lumen to facilitate and allow the passage of the catheter towards and through the stenosis to be dilated.

-The distal part of the catheter is coated with a durable hydrophilic coating to lubricate the catheter so that it can navigate through arteries. The maximum diameter of the guide wire must be no more than 0.36 mm = 0.014”.

The balloon is coated with the drug Paclitaxel, included in a physiologically inocuous matrix. The drug’s dose is 3 micrograms / mm² of balloon surface and it is intended to avoid cellular proliferation, consequently decreasing the re-intervention rate.

The drug is released from the balloon by means of a rapid inflation in a way so that a high dose of the drug is released in a very short period of time. For releasing the drug onto the artery wall, the inflation process must last from 30 seconds to 1 minute, but dilation of the lesion must be optimized by using longer inflation times at the operator’s discretion.

One radiopaque marker is located at each end of the balloon in order to mark its length and help the user to see the catheter while inside the patient. At the distal end of the balloon is the tip, which is rounded and atraumatic in shape in order to avoid damaging the arteries while it is being advanced.

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TransferTech offers a minimum drug loss during navigation, assuring durability and improving mechanical properties. The combination coupled to the lipophilic nature of both paclitaxel and the excipient, leads to an optimal drug absorption within 30-60 s.

TransferTech nanotechnology makes the difference, contributing to ensure effectiveness

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Clinical Support

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

ESSENTIAL in SV
ESSENTIAL ISR

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