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Chocolate - Landscape of Drug-Coated Balloons Catheter
The pillows and grooves of the Chocolate® platform were designed to minimize vessel wall trauma. This unique platform has been demonstrated to reduce flow limiting dissections and bail-out stenting. Chocolate Touch® is coated with the drug paclitaxel for improved long-term outcomes. It is indicated to treat peripheral vascular disease and does not require pre-dilatation.
Indications for use
The Chocolate Touch® Paclitaxel Drug-Coated PTA Balloon Catheter is coated with the anti-restenotic drug paclitaxel and 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
- Pregnant or breast feeding women or patients with known hypersensitivity to Paclitaxel
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 Chocolate Touch® Paclitaxel Drug-Coated 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.
