Singapore-based QT Vascular has received CE mark approval for its peripheral drug-coated balloon, Chocolate Touch.
The drug-coated balloon is said to combine the mechanical dilatation of a balloon catheter with the biological effect of a drug to treat occluded arteries.
According to the firm’s Endure study principal investigator professor Thomas Zeller, the Chocolate Touch aggregates the low trauma Chocolate platform with the proven drug paclitaxel.
"In my personal experience, the Chocolate Touch has produced excellent acute clinical outcomes," added Zeller.
QT Vascular CEO Dr Eitan Konstantino said: "Currently available first generation drug-coated balloons provide significant benefits to patients suffering from blockages in their legs, but they have limitations."
The company plans to introduce the Chocolate Touch in CE mark accepting countries later this year. The device not yet received approval in the US.
In addition, the company applied for CE mark approval for its drug-coated coronary balloon, Chocolate Heart.