Biotronik receives EU approval for smaller Passeo-18 Lux balloons

Medical Company Product News

Biotronik has been granted European regulatory approval for new variants within its Passeo-18 Lux drug-coated balloon (DCB) portfolio.

The company has been granted CE Mark approval for the new 2 mm and 2.5 mm sizes, which facilitate DCB treatment of below-the-knee arteries with the same minimally invasive 0.018 inch platform.

“Biotronik has received CE mark approval for smaller diameters of its Passeo-18 Lux drug-coated balloon.“

Biotronik's Passeo-18 Lux paclitaxel-coated balloon catheter has demonstrated its safety and efficacy in the treatment of peripheral arterial disease in the randomised, controlled BIOLUX P-II clinical trial, which was published in the Journal of American College of Cardiovascular Intervention.

This new launch completes the Passeo-18 Lux portfolio and provides physicians with another option for treating this complex patient population.

Dr Alexander Uhl, Biotronik's vice-president for marketing for vascular intervention, said: "Along with our rigorous clinical programme, the addition of smaller diameters to the Passeo-18 Lux DCB portfolio further establishes our brand as a leader in lower limb therapies."

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