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BIOTRONIK BIOLUX P-I clinical study results published

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Results demonstrate advantage of BIOTRONIK’s Passeo-18 lux drug-coated balloon catheter for the treatment of superficial femoral and popliteal artery disease

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The results of BIOTRONIK BIOLUX P-I clinical study have been published in Journal of Endovascular Therapy. This was announced by BIOTRONIK, manufacturer of cardio- and endovascular medical technology

BIOLUX P-I was a prospective, international, multi-centre, first-in-human, randomised, controlled trial that enrolled 60 patients at five centres in Germany and Austria. The study assessed the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) in treating de novo and restenotic femoropopliteal lesions, and the positive results were instrumental in gaining CE mark in December 2013.

Data collected at six and 12-month intervals demonstrated that patients treated with Passeo-18 Lux DCB were less likely to require treatment again.

At six months, patients treated with the Passeo-18 Lux DCB had a significantly lower late lumen loss (LLL) (0.51±0.72 vs. 1.04±1.00; p=0.033) and binary restenosis rate (11.5 per cent vs. 34.6 per cent; p=0.048) compared to the control percutaneous transluminal angioplasty (PTA) treated patients. Correspondingly, clinically-driven target lesion revascularization (TLR) was lower in the Passeo-18 Lux DCB group at 12 months (16 per cent vs. 52.9 per cent; p=0.020) for the as-treated population. In addition, patients receiving treatment with Passeo-18 Lux showed greater improvement in Rutherford class compared to baseline (72.0 per cent) versus those receiving treatment with PTA (65.2 per cent).

The results of the study are being used by BIOTRONIK as a foundation to further investigate Passeo-18 Lux in real world populations, such as the BIOLUX P-III All-Comers Registry, which is currently enrolling patients in Europe and Asia Pacific. Results from BIOLUX P-I are in line with other scientific data, suggesting that treatment with DCB is a viable option and has the potential to become the standard for treating femoropopliteal arteries.

EP News BureauMumbai

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