Biotronik Lands CE Mark for Smaller Diameters of Drug-Coated Balloon
Biotronik has received the CE Mark for smaller diameters of its Passeo-18 Lux drug-coated balloon, the company has announced.
The newly available 2- and 2.5-mm sizes facilitate DCB treatment of below-the-knee arteries with the same minimally invasive .018'' platform, giving physicians enhanced options for treating this complex patient population.
The safety and efficacy of the Passeo-18 Lux paclitaxel-coated balloon catheter for the treatment of peripheral arterial disease was established by the randomized, controlled BIOLUX P-I clinical trial, according to the company.
The results are comparable to other scientific data suggesting that DCB is a viable treatment option and has the potential to become standard of care in the superficial femoral artery, Biotronik says. — Jonathon Shacat