TriReme Medical announced in a company release that the first three patients were enrolled in a clinical study of its unique drug-coated Chocolate percutaneous transluminal angioplasty balloon. Andrew Holden, co-principal investigator of the study, performed these procedures at Auckland City Hospital, in Auckland, New Zealand.
The drug-coated Chocolate clinical study is a single arm trial that will enrol a minimum of 30 patients at up to four centres in New Zealand and Germany. The trial will evaluate the rate of procedural success immediately after treatment as well as persistence of positive outcomes at six and 12 months post procedure. All key outcomes of the trial will be evaluated by independent core laboratories.
According to TriReme Medical, the drug-coated Chocolate percutaneous transluminal angioplasty balloon is designed for the treatment of patients with vascular disease in their legs, known as peripheral arterial disease. The drug-coated Chocolate percutaneous transluminal angioplasty balloon is unique in that it combines the acute benefits of the US Food and Drug Administration (FDA) and CE approved Chocolate percutaneous transluminal angioplasty balloon with paclitaxel-based coating, an anti-proliferative drug proven to reduce the build-up of tissue in the vessel that can occur months after the original procedure. The underlying Chocolate percutaneous transluminal angioplasty balloon platform has demonstrated a very low rate of dissections and bail out stenting in clinical studies.
“The first three complex cases in this study highlight the advantages of the underlying Chocolate platform in creating a larger and more uniform lumen while minimising vessel trauma,” states Andrew Holden, director of Interventional Services at Auckland City Hospital and associate professor of Radiology at Auckland University School of Medicine, New Zealand.