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 stenoses 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 CECANOT Hospital in Santo Domingo, Dominican Republic in 19 patients with de novo coronary lesions. The results of this novel 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%.
Via: QT Vascular…