Opto Circuits India’s German arm Eurocor is ready to conduct three clinical trials with ‘Freeway’, the latest second-generation percutaneous transluminal angioplasty (PTA) balloon technology designed to treat critical limb ischaemia associated with peripheral arterial disease (PAD).

The patient studies will be carried out under the supervision of  Prof. Karl-Ludwig Schulte, consultant,  Königin Elisabeth Hospital, Berlin.

The first trial is being conducted across  20 clinics worldwide and involves 280 participants. The aim of the trial is to chart the relative degrees of treatment-based success achieved using the Paclitaxel-coated Freeway balloon in comparison to an uncoated balloon.

Paclitaxel is capable of preventing the proliferation of certain cells that are responsible for arterial restenosis. The Freeway balloon which is coated with Paclitaxel is expected to facilitate a more positive long-term result. This trial is currently in its final preparatory Phase and is soon to go live.

The second trial led by Prof. Josef Tacke, consultant,  at Passau’s Klinikum medical facility will  monitor treatment with Freeway and its effects on the restenosis following stent implantation. The stented area will be treated either using Freeway or an uncoated balloon, with relative efficacy compared after six months.

The third trial conducted by Prof. Johannes Lammer is designed to evaluate the effectiveness of medication-coated balloons compared to uncoated balloon in the treatment of in-stent restenosis.  The trial enrolled 75 patients at the General Hospital, Vienna.

“The success of Eurocor rests on intensive scientific research involving our products. For that reason, international trials of this kind are important as they enable us to continue providing our customers with the superior technical standard devices,” said Dr. Rembert Pogge von Strandmann, director clinical research & communication, Eurocor.

Eurocor GmbH is providing interventional cardiologists with innovative, coronary stent technologies and special cardiovascular devices.