QT Vascular Ltd., together with its subsidiaries, 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."
Source : qtvascular.com