Changing the Landscape of Drug-Coated Balloons

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.

* Data on file at TriReme Medical, LLC

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.