QT Vascular Ltd. has received 510(k) clearance from the U.S. Food and Drug Administration 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 an advanced catheter 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.
A drug coated version of the Chocolate PTCA is also in development, according to Eitan Konstantino, PhD, CEO of QT Vascular, a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease.