QT Vascular's Chocolate PTA Catheter to Be Distributed Globally by Medtronic
February 2, 2017—QT Vascular Ltd. announced a definitive agreement with Medtronic for the worldwide distribution of its Chocolate percutaneous transluminal angioplasty (PTA) catheter for a period of 5 years and automatically renewable for two additional 1-year periods. The companies continue to negotiate other aspects of their commercial relationship.
QT Vascular, which is based in Singapore, advised that the Chocolate PTA is approved for use as a stand-alone treatment or adjunctive treatment for stenosis in vessels above and below the knee in Europe, Australia, Turkey, Singapore, Hong Kong, and the United States.
Previously, sales of the Chocolate PTA device outside the United States have been conducted via country-specific distribution partners. In the United States, sales have been conducted through the direct sales force of the company's wholly owned California-based subsidiary, TriReme Medical LLC, and a distribution partner.
Under the new distribution agreement with Medtronic, transition of the Chocolate PTA business will occur on a country-by-country basis over the coming months, starting with the United States.
According to QT Vascular, the device's nitinol constraining structure is designed to provide atraumatic dilatation in the treatment of blocked arteries. The postmarket Chocolate Balloon Angioplasty Registry (BAR) postmarket registry of 490 patients showed that use of the Chocolate PTA resulted in low rates of dissections and bailout stenting. Principal Investigator Jihad Mustapha, MD, presented the final Chocolate BAR results of the below-the-knee cohort of patients at the 5th Annual Amputation Prevention Symposium in August 2015.