We’ve covered TriReme and its wittily named Chocolate balloon angioplasty catheter numerous times on our pages. Today’s big news is that the device has now been granted U.S. FDA 510(k) clearance for use in the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Coronary artery disease occurs when the coronary arteries become narrowed by a buildup of plaque, including cholesterol, fatty deposits, calcium, and other substances. As plaque accumulates over time, the diameter of the arterial lumen narrows, resulting in reduced or stopped blood flow. When this occurs in arteries supplying blood to the heart, it can cause chest pain, a heart attack, or even death.
Many interventional approaches are available to the cardiologist faced with a narrow or obstructed coronary vessel, including the use of angioplasty balloons to effectively compact the plaque deposit into the vessel wall.
Currently, the Chocolate PTA is used for the treatment of patients with peripheral arterial disease in which it has demonstrated low rates of dissection and bail-out stenting in clinical studies. The Chocolate PTCA differs from other balloon catheters by featuring a metallic frame around the balloon. This is intended to restrain the balloon in areas of less resistance, ensuring that more of its compressive capacity is directed towards the critical part of the lesion. It was designed with similar engineering principles to those utilised in the perpheral vascular device and is aimed to provide predictable and uniform dilatation of the coronary vasculature.
Despite the clearance, there is no clinical data available for the Chocolate PTCA at this point in time.
“Chocolate PTCA is an exciting new product for interventional cardiologists,” said Dr. Martin Leon of Columbia University Center for Interventional Vascular Therapy. “It leverages the strong clinical outcomes and low rates of dissections of the Chocolate PTA Balloon Catheter (Chocolate PTA) while providing an important new tool that could be now used in coronary arteries.”
“The coronary business is an important element of our 2015 growth. This new product approval demonstrates the team’s ability to effectively execute on our milestones,” said Dr. Eitan Konstantino, Chief Executive Officer of QT Vascular. “We look forward to working closely with physicians to generate clinical data and serve a larger patient population.”
Source: QT Vascular Ltd., PR Newswire