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

Smaller Diameters Gain CE Approval for Enhanced Treatment of Below-the-Knee Arterial Disease

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)


BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.