Noticias

Noticias

  • Título: TriReme Begins Enrollment In Study Of Drug Coated Chocolate Balloon
  • Fecha: 25-03-2014

  • TriReme Medical LLC announced that is has begun enrollment of patients in the clinical study of its one of a kind drug coated Chocolate PTA balloon for treatment of patients with peripheral arterial disease (PAD). TriReme Medical LLC is a subsidiary of Singapore based QT Vascular Ltd.

    The drug-coated Chocolate PTA balloon is unique in its combination of acute benefits of the FDA and CE approved Chocolate PTA balloon with paclitaxel-based coating. This is an anti-proliferative drug shown to reduce the build-up of fatty tissue in vessels that can occur months after the original clinical procedure. The underlying platform of the Chocolate PTA balloon has established a very low rate of dissections and bail out stenting in clinical studies.

    Peripheral arterial disease results from the build-up of fatty substances that collect and bind to artery linings, a process known as atherosclerosis. The build-up narrows the artery by thickening its internal linings and limits blood flow to vital tissues and organs. Commonly affected areas include arteries in the legs, arms, kidneys, and in the neck. The disease affects approximately 202 million people around the world.

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

    Dr. Eitan Konstantino, President and CEO of the TriReme Medical, said, “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. 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.”

    The clinical study for drug-coated Chocolate is a single arm trial that will test in a minimum of 30 patients with vascular disease in legs also known as PAD. The study will assess the procedural success rate immediately following treatment. The persistence of positive outcomes at six and twelve months post procedure will be also observed. Dr. Andrew Holden, co-principal investigator of the clinical study, performed the procedures at Auckland City Hospital in Auckland, New Zealand. All key outcomes of the study will be investigated by independent core laboratories.



  • Fuente: endovascular.es