Biotronik receives CE Mark approval for Passeo-18 Lux balloon

Biotronik has announced the European launch of the new Passeo-18 Lux drug-releasing balloon, for use in the treatment of femoropopliteal lesions.

The device has been granted CE Mark approval based on its strong performance in the BIOLUX P-I study, which confirmed its clinical efficacy in treating de novo and restenotic femoropopliteal lesions.

Data collected at six and 12-month intervals demonstrated that patients treated with Passeo-18 Lux were less likely to require treatment again. It has also been shown to be extremely deliverable and easy to use, compared with other technologies and treatment options for these demanding vessels.

Alain Aimonetti, vice-president of sales and business development for vascular intervention at Biotronik, said: "Our significant investment in developing outstanding peripheral vascular devices, supported by clinical evidence, is translating into real clinical benefits."

Earlier this month, the company reported data from a new study called ECOST, which demonstrated the extensive cost-effectiveness benefits provided by its Home Monitoring system.