Extender
Drug Eluting Coronary Balloon Catheter



The extender is a drug-eluting balloon dilatation catheter designed for percutaneous transluminal coronary angioplasty (PTCA) and has been optimized for the treatment of patients with coronary arterial disease.

OVERVIEW

Extender

A Drug-Eluting PTCA Balloon Catheter is used to treat coronary vessels with a balloon structure that releases drugs at the tip.

It treats interventional treatment of coronary artery disease by providing fast and effective drug delivery.

 

HIGH PERFORMANCE LONG-TERM EFFECTIVE CLINICAL RESULTS

 

Mechanism of Action

Arterial periphery injuries provoke an inflammatory reaction with the excretion of growth factors that trigger the onset of cell division and smooth November cell migration by balloon dilatation.

Indications

Myocardial perfusion or coronary artery bypass stenosis or occlusion to provide or balloon dilatation of the endoprosthesis, including with thin veins after treatment with the remaining stenosis and coronary dilatation of endovascular prostheses of pre-and post-dilatation indicated.

 

Extender PTCA catheter is indicated for the dilatation of the affected segments of a coronary artery or a coronary bypass to enhance myocardial perfusion. This paclitaxel-eluting balloon feature a proper coating technology that consistently delivers paclitaxel, an anti-restenotic drug during very brief inflation times, while also minimizing washout of the drug during delivery and placement of the drug-eluting balloon. Balloon catheters offer excellent pushability, trackability, and crossability due to a low balloon profile, low tip entry profile, and hydrophilic coating on the distal shaft of the catheter. Paclitaxel eluting coronary balloon catheter is especially indicated for the treatment of coronary in-stent restenosis.

 

Major inclusion criteria

  • Signed data release form
  • Patients with the restenotic lesion in a previously stented area of a coronary artery (irrelevant whether BMS or DES related)
  • Target reference vessel diameter: 2 - 4.5 mm
  • Target lesion length: 8 - 28 mm
  • Target lesion stenosis: > 50 % - < 100 %
  • Patient with allergy against appropriate anticoagulation/antiplatelet therapy

Patients with allergy against paclitaxel Patients with a target lesion that was previously treated by brachytherapy

FEATURES

ADVANTAGES

  • Excellent pushability
  • Targeted drug delivery into the vascular wall
  • Single shot, short-term Paclitaxel delivery for long-term vessel patency
  • Homogeneous and complete drug release
  • Low profile tip and balloon design for reduced friction and advanced crossing performance
  • Homogeneous drug delivery Effectively inhibiting proliferation
  • No airborne particles at any time and no premature release of Paclitaxel Hydrophilic coating delivers
  • Paclitaxel is homogeneous to the vessel wall instantaneously upon contact
  • Hydrophilic coating delivers Paclitaxel without any negative side effects or inflammation
  • Load secured to achieve the therapeutic window within 30 seconds of inflation time.

 

The balloon catheter offers excellent repellency, traceability, and crossability thanks to its low balloon profile, low-end inlet profile, and hydrophilic coating on the distal shaft of the catheter.

Paclitaxel-release coronary balloon catheter is especially indicated for the treatment of intra-coronary stent restenosis.

Paclitaxel prevents restenosis by stabilizing microtubule formation and thus preventing cells from going through replication stages, resulting in inhibition of cell division.

 

TECHNICAL SPECS

Dose of Paclitaxel Drug   3.0 - 3.5 μg / mm2
Aid Matter   Iopromid
Balloon Diameter    2.0 mm - 5.0 mm
Catheter Diameter   3F
Balloon Lenght    10, 15, 17, 20, 26, 30 mm
Balloon Folding Profile   2.0 - 4.0 mm: 3 layer
Radiopasity    Pt-Ir Marker
Applicable Guideware    0.014"
Catheter Shaft    RX
Catheter Lenght    120 cm,150 cm
Catheter Structure   PA/PEBAX, Hypotube
Drug/Quantity    Paklitaxel 1 μg/mm2

ORDERING INFO

  BALLOON LENGTH (120 cm) BALLOON LENGTH (150 cm)
Diameter 10 mm 15 mm 17 mm 20 mm 26 mm 30 mm 10 mm 15 mm 17 mm 20 mm 26 mm 30 mm
(mm)
2.0 CR2010M CR2015M CR2017M CR2020M CR2026M CR2030M CR2010X CR2015X CR2017X CR2020X CR2026X CR2030X
2.5 CR2510M CR2515M CR2517M CR2520M CR2526M CR2530M CR2510X CR2515X CR2517X CR2520X CR2526X CR2530X
2.75 CR27510M CR27515M CR27517M CR27520M CR27526M CR27530M CR27510X CR27515X CR27517X CR27520X CR27526X CR27530X
3.0 CR3010M CR3015M CR3017M CR3020M CR3026M CR3030M CR3010X CR3015X CR3017X CR3020X CR3026X CR3030X
3.5 CR3510M CR3515M CR3517M CR3520M CR3526M CR3530M CR3510X CR3515X CR3517X CR3520X CR3526X CR3530X
4.0 CR4010M CR4015M CR4017M CR4020M CR4026M CR4030M CR4010X CR4015X CR4017X CR4020X CR4026X CR4030X