Chocolate Heart™ is the drug-coated version of the Company’s Chocolate® PTCA balloon that has been commercially available in the United States (“US”) since late 2014. Chocolate® PTCA features a unique nitinol constraining structure that causes the balloon to open in a controlled uniform fashion, thus is designed to reduce acute trauma, dissections, and unplanned stenting compared to conventional balloons. Initial evidence of this has previously been demonstrated in a trial of the peripheral version of Chocolate® known as Chocolate® PTA (“Chocolate BAR”)1. The Company has added a proprietary coating containing the proven drug, paclitaxel, to the Chocolate® PTCA platform in order to reduce the incidence of repeat procedures. This combination of an atraumatic balloon platform and a proven therapeutic agent is intended to allow certain patients to be treated with Chocolate Heart™ while avoiding the need for a permanent implant such as a metallic stent.
Drug-coated balloons represent a rapidly growing new category of device that combines the mechanical dilatation of a balloon catheter with the biological effect of a drug to treat occluded arteries in the leg. These devices have been available for several years in Europe and were recently approved in the United States. Since their approval in the U.S., adoption has been increasing and CMS (Centers for Medicare and Medicaid Services) has granted additional reimbursement for these devices. According to some analyst estimates3, revenues for drug-coated peripheral balloons are expected to reach $1 billion by 2020. The Company believes that drugcoated balloons may also play an important role in the future in the treatment of patients with disease in their coronary arteries.
More information can be found from QT Vascular Ltd website.
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