BIOTRONIK Announces Expansion of Passeo-18 Lux Drug-Coated Balloon Portfolio

BUELACH, Switzerland, January 26, 2016 – BIOTRONIK, a leader in cardio- and endovascular medical technology, announced today that it has received CE mark approval for smaller diameters of its Passeo-18 Lux drug-coated balloon (DCB). The newly available 2 mm and 2.5 mm sizes facilitate DCB treatment of below-the-knee arteries with the same minimally invasive .018'' platform, thus completing the Passeo-18 Lux portfolio and granting physicians enhanced options for treating this complex patient population.

The safety and efficacy of the Passeo-18 Lux paclitaxel-coated balloon catheter in treatment of peripheral arterial disease (PAD) was established by the randomized, controlled BIOLUX P-I clinical trial¹. The encouraging results, published in the Journal of Endovascular Therapy, 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 (SFA).

1. ^{Scheinert D, et al. J Endovasc Ther. 2015, 22(1)}
   
2. ^{Zeller et al. J Am Coll Cardiol Intv. 2015, 8(15)}