Drug Coated Chocolate® Balloon Study Kicks Off

TriReme Medical LLC, tells us that the first three patients were enrolled in a clinical study of its funkily named Chocolate® PTA drug-coated balloon. Dr. Andrew Holden, co-Principal Investigator of the study, performed these procedures at Auckland City Hospital, in Auckland, New Zealand.

Background

The drug-coated Chocolate® PTA balloon for treatment of peripheral artery disease, is a frequent visitor to our pages. Its uniqueness lies in its external constraining mesh that prevents local over-inflation and with it dissections of the vessel it’s attempting to open. Furthermore it combines that feature with a 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® PTA balloon platform has demonstrated a very low rate of dissections and bail out stenting in clinical studies as we reported last month.

The drug-coated Chocolate® clinical study is a single arm trial that 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 persistence of positive outcomes at 6 and 12 months post procedure. All key outcomes of the trial will be evaluated by independent core laboratories.

Physician comments

“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,” stated Dr. Andrew Holden, Director of Interventional Services at Auckland City Hospital and Associate Professor of Radiology at Auckland University School of Medicine.

Company comments

“First Generation drug-coated balloons are based on Plain Old Balloon Angioplasty (POBA) technology that goes back more than 30 years. POBA is well known to induce significant vessel trauma and often requires adjunctive stenting to complete the procedure,” added Dr. Eitan Konstantino, President and CEO, TriReme Medical. “The mere addition of a drug does not solve this issue. The drug coated Chocolate® PTA balloon is the only product that is designed to address both the acute trauma and long term results.”

TriReme, a subsidiary of Singapore based QT Vascular Ltd., is an emerging leader in the development and commercialization of next generation minimally invasive devices for the treatment of complex arterial disease. The company is focused on the US and the emerging Asian markets.

Source: TriReme Medical LLC, PR Newswire

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