FDA Clears QT Vascular's Chocolate XD PTCA Balloon

June 27, 2016—QT Vascular Ltd. announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) 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.

According to the company, the Chocolate platform utilizes a nitinol constraining structure that is mounted on a semicompliant balloon. It is designed to reduce vessel trauma by providing a balloon inflation that is predictable, controlled, and uniform. It is now approved for use in de novo and restenotic lesions.

QT Vascular is based in Singapore. The company’s United States subsidiary is TriReme Medical LLC, which is based in Pleasanton, California.