TriReme Medical (Pleasanton, California), part of*QT Vascular, a company based in Singapore, received European regulatory approval for its new Chocolate Heart drug-coated percutaneous transluminal coronary angioplasty (PTCA) Balloon for pushing apart ste**ses in the coronary arteries. It’s a paclitaxel Coated version of*the Chocolate PTCA balloon, a device cleared*in the U.S. a couple years ago.
The company believes the Drug coating will provide some patients the ability to receive treatment without leaving a stent behind.
From QT Vascular:
The FIH study of Chocolate Heart™ was conducted at CECA**T Hospital in Santo Domingo, Dominican Republic in 19 patients with de **vo coronary lesions. The results of this **vel study were recently presented by the IVUS core lab principal investigator, Dr. Alexandre Abizaid of Dante Pazzanese Hospital in Sao Paolo, Brazil. In-hospital and after 30 days, the incidence of acute closure was 0% compared to over 9%2 for conventional Balloon angioplasty. At 6 months, the late lumen loss was only 0.01mm with a rate of target lesion re-treatment of only 5%.
07-14-2016, 08:31 PM
Chocolate Heart, a New Drug Coated PTCA Balloon Cleared in Europe
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