Clinical Study Begins for TriReme's Drug-Coated Chocolate PTA Balloon

March 24, 2014—TriReme Medical LLC (Pleasanton, CA), a subsidiary of QT Vascular Ltd. (Singapore), announced the commencement of enrollment in a clinical study of its drug-coated Chocolate percutaneous transluminal angioplasty (PTA) balloon for the treatment of peripheral arterial disease. The study’s coprincipal investigator, Andrew Holden, MD, enrolled the first three patients, performing the procedures at Auckland City Hospital in Auckland, New Zealand.

In the company’s press release, Dr. Holden commented, “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 minimizing vessel trauma.” Dr. Holden is Director of Interventional Services at Auckland City Hospital and Associate Professor of Radiology at Auckland University School of Medicine.

The single-arm trial will enroll a minimum of 30 patients at up to four centers in New Zealand and Germany. The trial will evaluate the rate of procedural success immediately after treatment, as well as the persistence of positive outcomes at 6 and 12 months after the procedure. All key outcomes of the trial will be evaluated by independent core laboratories.

According to TriReme Medical, the drug-coated Chocolate PTA balloon combines paclitaxel, an antiproliferative drug, with the acute benefits of the company’s Chocolate PTA balloon, which has received both US Food and Drug Administration and European CE Mark approval.

The underlying Chocolate PTA balloon platform has demonstrated a very low rate of dissections and bailout stenting in data from the Chocolate BAR Registry that were presented by Tony Das, MD, at the LINC 2014: Leipzig Interventional Course in Germany in February. Also in February, Cordis Corporation (Bridgewater, NJ) announced that it has entered into an agreement with TriReme Medical for exclusive distribution rights for the Chocolate PTA balloon catheter.