Biotronik study demonstrates efficacy of Passeo-18 Lux drug-coated balloon

Biotronik has announced the publication of results from its BIOLUX P-I clinical study in the Journal of Endovascular Therapy.

The study enrolled 60 patients at five centres in Germany and Austria to assess the safety and efficacy of its Passeo-18 Lux drug-coated balloon (DCB) in treating de novo and restenotic femoropopliteal lesions.

Data collected at six and 12-month intervals demonstrated that patients treated with Passeo-18 Lux DCB were less likely to require treatment again, with significantly lower late lumen loss and binary restenosis rates compared to those treated with percutaneous transluminal angioplasty.

Positive results from this study were instrumental in helping Biotronik gain European CE Mark approval for this device in December 2013.

Dr Alexander Uhl, Biotronik's vice-president of marketing within its vascular intervention business, said: "Keeping in line with Biotronik's culture of heavy investment in clinical studies, we will continue to investigate and prove its effectiveness so that patients and physicians can choose this product with the fullest confidence."

Last month, the company announced data from a study showing the self-expanding Astron stent's safety, efficacy and beneficial clinical outcomes in the treatment of iliac artery disease.