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QT Vascular gets US FDA nod for second generation Chocolate PTCA balloon catheter
QT Vascular, which is engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, has received the US Federal Drug Administration's approval for its second generation of the Chocolate Percutaneous Transluminal Coronary Angioplasty balloon catheter (Chocolate PTCA).
Building from the clinical experience of the first generation of the Chocolate PTCA - which has been used extensively in coronary cases, the second generation model features a highly lubricious hydrophilic coating on its distal shaft. The addition of this coating is expected to reduce friction and enhance the catheter's movement in highly tortuous lesions.
"Unlike some peripheral vessels, coronary arteries can be extremely tortuous, thus providing a delivery challenge for novel devices. Nevertheless, we have been pleased with the reception of Chocolate PTCA Gen 1 and are continuing to build our experience and user base with this unique catheter," stated Eitan Konstantino, chief executive officer of QT Vascular. "With this rapid approval of Gen 2, we now expect greater ease of use in a broad subset of coronary lesions which we believe will allow us to increase the user base even further."