QT Vascular exceeds patient enrollment goal in 4Q14
Its drug-coated balloon has proven successful.
Catalist-listed QT Vascular Ltd., a developer and manufacturer of minimally invasive medical devices for the treatment of vascular diseases, announced that it has substantially exceeded its patient enrollment goal for the fourth quarter of 2014.
According to a media release by QT Vascular, ENDURE is a single-arm, core-lab adjudicated, multi-center clinical trial conducted at top centers in Europe and New Zealand. The trial is designed to evaluate the safety and efficacy of Chocolate® Touch at 30 days, 3 months, 6 months, and 12 months. Clinical assessments include amputation-free survival and Rutherford Grade change while core lab measurements will include late lumen loss, vessel patency and target lesion revascularization.
Chocolate® Touch is a novel drug-coated peripheral balloon that combines the acute benefits of the Chocolate® PTA Balloon Catheter with the potential long-term benefits of a paclitaxel-based coating. The Chocolate® platform represents a breakthrough in PTA balloon catheters. Used for the treatment of patients with peripheral arterial disease, it was designed to provide predictable, uniform, less traumatic dilatation and has demonstrated a very low rate of dissection and bail-out stenting.