CHOCOLATE® PTA Balloon Catheter

The CHOCOLATE® PTA Balloon Catheter with Nitinol Pressure Shield1 is designed to provide protection from torsional, radial, and longitudinal stresses that can lead to vessel trauma.

1. Nitiol Constraining Structure. Source: Interim resulst from the CHOCOLATE® Bar Study.

Product Description

The CHOCOLATE® PTA Catheter with a Nitinol Pressure Shield* is designed to provide protection from torsional, radial and longitudinal stresses that can lead to vessel trauma. The CHOCOLATE® PTA Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries.

Pillows and grooves are designed to reduce dissection rates by providing modulated dilatation and minimizing vessel wall trauma.

Key Features

  • Nitinol pressure shield*
  • Uniform dilatation pillows
  • Plaque-channeling grooves

Performance Benefits

Design to provide:

  • Controlled, Predictable, Uniform Inflation
  • Reduced “Dog-Boning”
  • Concentric Secondary Profile­

*Nitinol Constraining Structure.
**Source: Interim results from the CHOCOLATE® BAR Study.

Clinical Resources
Ordering Information

In the United States, email us your order at GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com or call us at 800.327.7714.

Balloon Diameter Balloon Length Guidewire Introducer Sheath Nominal Pressure Rated Burst Pressure Reference Number  
2.5 mm 40 mm 0.014” 5F 9 atm 14 atm CB1415025040OTW
2.5 mm  80 mm 0.014” 5F 9 atm 14 atm CB1415025080OTW
2.5 mm  120 mm 0.014” 5F 9 atm 14 atm CB1415025120OTW
3.0 mm  40 mm 0.014” 5F 9 atm 14 atm CB1415030040OTW
3.0 mm  80 mm 0.014” 5F 9 atm 14 atm CB1415030080OTW
3.0 mm  120 mm 0.014” 5F 9 atm 14 atm CB1415030120OTW
3.5 mm  40 mm 0.014” 5F 9 atm 14 atm CB1413535040OTW
3.5 mm  80 mm 0.014” 5F 9 atm 14 atm CB1413535080OTW
3.5 mm  120 mm 0.014” 5F 9 atm 14 atm CB1413535120OTW
4.0 mm  40 mm 0.014” 5F 9 atm 14 atm CB1413540040OTW
4.0 mm  80 mm 0.014” 5F 9 atm 14 atm CB1413540080OTW
4.0 mm  120 mm 0.014” 5F 9 atm 14 atm CB1413540120OTW
5.0 mm  40 mm 0.018” 6F 6 atm 12 atm CB1812050040OTW
5.0 mm  80 mm 0.018” 6F 6 atm 12 atm CB1812050080OTW
5.0 mm  120 mm 0.018” 6F 6 atm 12 atm CB1812050120OTW
6.0 mm  40 mm 0.018” 6F 6 atm 12 atm CB1812060040OTW
6.0 mm  80 mm 0.018” 6F 6 atm 12 atm CB1812060080OTW
6.0 mm  120 mm 0.018” 6F 6 atm 12 atm CB1812060120OTW
IFU

Indications For Use:

The CHOCOLATE® PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries.

Contraindications:

  • Use in the coronary and cerebral vasculature.
  • Lesion is unable to be crossed with a guidewire.

Warnings:

  • STERILE product, to be for one-time use only. Re-sterilizing or re-using may compromise the structural integrity of the device and may create a risk of contamination which, in turn, may result in health risks to patients.
  • The inflated diameter of the balloon should correspond to the diameter of the vessel for treatment.
  • The catheter should be used under fluoroscopic guidance. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. Do not advance against resistance without first determining the cause of the resistance and taking appropriate action.
  • Balloon pressure should never exceed the rated burst pressure (RBP). Exceeding the RBP may result in balloon rupture and CS failure.
  • Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.
  • Use the CHOCOLATE® PTA Balloon Catheter prior to the “Use By” date specified on the package.
  • The CHOCOLATE® PTA Balloon Catheter has not been tested for post-dilatation of stents or advancement through stents, calcified lesions or synthetic vascular grafts. Do not use in the presence of a freshly deployed stent.

Precautions:

  • Ensure the balloon size and device functionality are suitable for the intended procedure.
  • The device should only be used by trained physicians.
  • Use appropriate anticoagulant and vasodilator therapy during and after the procedure.
  • Do not pre-inflate prior to use. Prepare as directed in the Balloon Catheter Preparation section.
  • If you choose to rotate the catheter, alternate the rotating direction. Do not rotate more than three (3) times in the same direction consecutively.

Potential Complications/Adverse Effects:

The following complications may result from a balloon dilatation procedure, but may not be limited to:

  • Abrupt closure/occlusion.
  • Allergic reaction to medication, contrast medium & Nitinol
  • Amputation
  • Arterial dissection or perforation
  • Arterial spasm
  • Arterio-venous fistula
  • Bypass surgery
  • Cardiorespiratory
  • Death
  • Emboli (air tissue, thrombi, material from devices used in the procedure)
  • Hemorrhage or hematoma
  • Infection, local or systemic
  • Pseudo-aneurysm
  • Renal failure
  • Restenosis of treated artery
  • Surgical repair of vascular access site
  • Thrombosis

Please refer to the Instructions For Use for complete information.