SINGAPORE, June 27, 2016 /PRNewswire/ -- QT Vascular Ltd., together with its subsidiaries (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced today it has received 510(k) clearance from the US Food and Drug Administration ("FDA") for the sale and distribution of the Chocolate XD™ PTCA 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 utilizes a unique nitinol constraining structure that is 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 the most advanced catheter ever developed by the Group for use in coronary arteries and 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," stated Eitan Konstantino, PhD, CEO of QT Vascular. "Chocolate XD™ is yet another of our devices utilizing the Chocolate® platform that is already commercial in the United States. A drug coated version of the Chocolate® PTCA is also in development consistent with our vision of minimizing the need for permanent implants placed in arteries. We intend to increase our focus on the coronary market and offer patients alternatives to conventional old balloons."
ABOUT QT VASCULAR LTD. (SGX Stock code: 5I0)
QT Vascular Ltd. together with its subsidiaries ("QT Vascular" or the "Group"), is an emerging leader in the development and commercialization of next generation minimally invasive products for the treatment of complex vascular disease. QT Vascular works closely with leading physicians and scientists from around the world to create differentiated devices that improve procedural and clinical outcomes.
QT Vascular is based in Singapore with a US subsidiary, TriReme Medical LLC ("TriReme Medical"), based in Pleasanton, California. TriReme Medical's range of percutaneous transluminal angioplasty ("PTA") and percutaneous transluminal coronary angioplasty ("PTCA") products include (i) Chocolate® PTA Balloon Catheter, (ii) Chocolate® PTCA Balloon Catheter, (iii) GliderXtremeTM PTA Balloon Catheter, (iv) GliderfleX® PTA Balloon Catheter and (v) GliderTM PTCA Balloon Catheter, all of which have the CE mark that allows them to be sold in Europe, and FDA clearance to be sold in the United States. Additionally, the GliderXtremeTM PTA Balloon Catheter has the regulatory clearance in China and Japan, while the GliderTM PTCA Balloon Catheter has the regulatory clearance in Japan. These products are sold by the Group's direct sales team and through its main distributors: (i) Cordis Corporation (a wholly-owned subsidiary of Cardinal Health, Inc.), (ii) Shandong Weigao Group Medical Polymer Co Ltd and (iii) Century Medical, Inc.
The Group's drug coated version of the Chocolate® PTA Balloon Catheter, Chocolate Touch™, and the Chocolate® PTCA Balloon Catheter, Chocolate Heart™, have the CE mark that allows them to be sold in Europe.
For more information, please visit the company website at www.qtvascular.com.
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SOURCE QT Vascular Ltd.