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QT Vascular to implement changes to Chocolate Touch clinical trials
MEDTECH firm QT Vascular will be implementing changes to the informed consent of its Chocolate Touch clinical trials and updating its study protocol to ensure ongoing independent safety review of data.
The company will also implement measures to "reduce potential for patients which may be lost during the follow up of the study", it said in a bourse filing on Monday.
The move follows recomendations by the United States Food and Drug Administration (FDA) to healthcare providers over the potential for increased long-term mortality after using paclitaxel-coated balloons and paclitaxel-eluting stents.
Chocolate Touch is the company’s paclitaxel-coated balloon product, which is enrolling patients for clinical trials. These trials are randomised to evaluate the safety and effective of the product for the treatment of disease in the superficial femoral and popliteal arteries in the legs.
“While the FDA letter provides recommendations regarding the use of commercially distributed paclitaxel-coated products it does not reference ongoing clinical trials,” QT Vascular said.
It added that it has obtained general feedback from the FDA regarding how updated safety communication applies to its ongoing trials and hence the implementation of changes and added measures for its trials.
In January, the company announced it was expanding an ongoing study for Chocolate Touch to include the use of an additional surgical procedure after receiving approval from the FDA.
QT Vascular shares were down 0.1 Singapore cent at S$0.005 apiece on Monday as of 2.16pm.