TriReme Medical, a U.S. subsidiary of Singapore-based QT Vascular, received FDA clearance for the Chocolate PTCA Balloon Catheter. The device is very much based on the company’s Chocolate PTA balloon catheter, a product designed to address stenosis in the vasculature of the legs. The Chocolate PTCA is indicated for dilation of the coronary artery or bypass graft stenosis for improving myocardial perfusion.
The balloon itself has rings positioned along its tract that prevent it from expanding into a uniform shape. This prevents the balloon from inflating in the shape of a bone, with the edges being larger than the center of the balloon. Additionally, the valleys that are formed allow large bits of particularly hard calcification to snuggle within them rather than being pushed into the vessel wall where they can cause damage.
From the announcement:
Currently, the Chocolate PTA is used for the treatment of patients with vascular disease in their legs, known as peripheral arterial disease. The Chocolate PTA has demonstrated low rates of dissections and bail-out stenting in clinical studies (1). The Chocolate PTCA was designed with similar engineering principles and is aimed to provide predictable and uniform dilatation of the coronary vasculature. There is no clinical data available for the Chocolate PTCA at this point in time.
Product page: Chocolate PTA…