FDA clears QT Vascular Chocolate XD balloon

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QT Vascular, together with its subsidiaries, has received 510(k) clearance from the US Food and Drug Administration for the sale and distribution of the Chocolate XD percutaneous transluminal coronary angioplasty catheter for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.

The Chocolate platform utilises a nitinol-constraining structure mounted on a semi-compliant balloon. It is designed to reduce vessel trauma by providing a balloon inflation that is predictable, controlled, and uniform. Chocolate XD is designed for improved trackability and deliverability with a flexible distal end and reduced proximal shaft profile. It is now approved for use in de novo and restenotic lesions.

“We are thrilled to receive this regulatory approval,” states Eitan Konstantino, chief executive officer of QT Vascular. “A drug-coated version of the Chocolate PTCA is also in development. We intend to increase our focus on the coronary market and offer patients alternatives to conventional old balloons.”