LEIPZIG, Germany and BUELACH, Switzerland ,

24-Month Data from the BIOLUX P-III Registry Show Safety and Efficacy of Passeo-18 Lux DCB, Even in Challenging Patient Subgroups

Results From the World’s Second Largest All-Comers Drug-Coated Balloon Registry Show Continuing Benefit of Passeo-18 Lux in Patients with Critical Limb Ischemia and Diabetes with Positive Outcomes in Terms of Patient Safety

Data from the BIOLUX P-III All-Comers Registry presented at LINC 2019 highlighted the safety and efficacy of BIOTRONIK’s Passeo-18 Lux* drug-coated balloon (DCB), even in challenging patient subgroups. A number of presentations during LINC congress focused on the 24-month results of the all-comers DCB registry, covering aspects such as mortality rates and subgroup analyses of patients with critical limb ischemia (CLI) and diabetes.

During a session dedicated to new data on peripheral DCBs and stents, Prof. Gunnar Tepe, Institute of Radiology, Rosenheim, Germany, presented the 24-month full-cohort data from the BIOLUX P-III registry. The full cohort comprises of 882 enrolled patients. The data reports 88.8% of freedom from clinically-driven target lesion revascularization (fcd-TLR)1. The full cohort of the registry included patients with highly advanced disease states, of which 42.1% were diagnosed as CLI and almost 20% with below-the-knee (BTK) lesions1. Despite the high amount of BTK and complex lesions (32.6% TASC C and D), the major target limb amputation rate remained very low at 7.3% at two years1.



1. Tepe G. BIOLUX P-III Passeo-18 Lux all-comers registry: 24-month results for the full cohort. Presented at: LINC, Jan 22, 2019; Leipzig, Germany.

2. Journal of the American Heart Association. https://doi.org/10.1161/JAHA.118.011245

3. Brodmann M. Twenty-four months outcomes of patients presenting with critical limb ischemia within the BIOLUX P-III registry – a real-world clinical trial treating atherosclerotic arteries with a paclitaxel covered balloon. Presented at: LINC, Jan 22, 2019; Leipzig, Germany.

4. Dahm J.B. Diabetic patients in a real-world clinical trial treated for peripheral arterial disease with a paclitaxel covered balloon. Presented at: LINC, Jan 22, 2019; Leipzig, Germany.


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.