ESSENTIAL. Essential drug-eluting balloon.

Paclitaxel-releasing coronary dilation balloon catheter

INDICATIONS
Catheter balloon with Paclitaxel release with Rapid Exchange (RX) design, indicated for dilation with balloon of the stenotic portion of a coronary artery or the stenosis of substitutive bypass grafts of coronary arteries, including small vessels, as well as for residual stenosis after treatment with balloon and endoprosthesis and pre- and post-dilation of coronary endovascular prostheses, for the purpose of improving myocardial perfusion.

DESCRIPTION
The catheter body has a proximal simple lumen and distal coaxial lumen: The simple lumen is comprised of a hypotube that gives the catheter high pushing ability and allows the passing of inflation liquid from the Luer connector to the balloon. The coaxial lumen has two functions:
– Internal passage lumen as guide for the wire.
– External inflation lumen in direct connection with the hypotube.

The balloon, or inflatable segment of known diameter and length, is found at the distal end. The balloon is outlined by radiopaque markers and ends in a smooth and atraumatic tip.

The balloon is coated in the drug Paclitaxel, including a physiologically innocuous matrix.

It is outlined by radiopaque markers at proximal end, and it ends in a smooth and atraumatic tip.

The balloon is coated in the drug Paclitaxel, including a physiologically innocuous matrix.

The Luer connector is found at the proximal end, for connecting to different accessories.

Characteristics

For the design and manufacture of the balloon ESSENTIAL iVascular uses its own coating technology called TRANSFERTECH.

TRANSFERTECH is a multidrop nanotechnology that allows you to obtain very fine monodiameter drops.

The result is a multilayer coating with excellent mechanical properties:

  • Increases adhesion to the balloon: Reduces handling losses
  • Improves durability: Reduces losses during navigation

This technology provides ultra-thin coatings with:

  • Homogeneous distribution of the drug
  • The same dose throughout its length
  • Uniformity of drug loading 2.5 – 3.5 μg/mm2

The advantages of using this technology are:

  • Low profiles: minimises losses during the navigation stage
  • Slight solubilisation of the coating until reaching the 'gel effect' avoiding: Particle release and delamination
  • Microcrystalline structure of the Paclitaxel:
    • Rapid absorption and transfer of the drug to the arterial wall
    • High retention of drug with respect to time
  • The design of the catheter gives it excellent pushing ability and crossing capacity. Balanced transition of force. Anti-kinking.
  • Polymer tungsten radiopaque markers for greater tip flexibility. Exceptional reach capacity.
  • Durable hydrophilic coating (Hydrax) which ensures sustainable performance and control throughout the procedure.
  • Exceptional ability to cross the lesion due to its tip profile.

Specifications

  • Material: Nylon/Pebax (the product does not contain latex components).
  • Coating of the balloon: 3 mg/mm2 Paclitaxel.
  • Excipient: organic ester. Lipophilic, biocompatible and biodegradable.
  • Balloon: Semi-compliant (10-15% of the rated pressure for RBP).
  • Rated pressure: 6 atm
  • Maximum recommended pressure (RBP): 16 atm
  • Estimated bursting pressure (ABP): 20 atm
  • Recommended wire guide: 0.014″
  • Entry profile: 0.017″
  • Compatibility with introducer: 5F for all diameters (6F for kissing balloon technique).
  • Deflation times: 3 s (average).
  • Radiopaque markers: 2 polymeric markers on a tungsten base with high flexibility.
  • Useful catheter dimension: 142 cm.
  • Diameters available: 1.5 to 4.5 mm.
  • Available lengths: 10 to 40 mm.

Product page

See specifications

Downloadable

Pre-clinical study article: “Safety and Efficacy of Different Paclitaxel-eluting Balloons in a Porcine Model”

http://www.ivascular.global/coronary/essentia