LISBON, Portugal,

CIRSE 2018: 24-Month Data Shows Continuing Benefit of Passeo-18 Lux DCB in a Challenging Population

One of the World’s Largest Drug-Coated Balloon Registries, BIOLUX P-III Shows Excellent Results at 24 Months and 12 Months in Superficial Femoral Artery and In-Stent Restenosis Subgroups, Respectively

During this year’s CIRSE congress, Prof. Christoph Binkert, Kantonsspital Winterthur, Switzerland, presented 24-month outcomes of the world’s second largest Real-World DCB registry, BIOLUX P-III. Data presented included the 24-month outcomes of the SFA subgroup and 12-month results for the in-stent restenosis (ISR) subgroup.

For the superficial femoral artery (SFA) group, at 24 months patients treated with BIOTRONIK’s Passeo-18 Lux DCB (n=441) demonstrated 91.7% freedom from clinically-driven target lesion revascularization (FCD-TLR) and 78.0% primary patency (PP). This is particularly noteworthy given the complex patient cohort, with 42% of included lesions classified as moderately or heavily calcified.1

“Drug-coated balloons are now established as an effective treatment for the SFA with low rates of re-intervention and good patency at 12 months seen in previously presented data,” commented Prof. Binkert. “The goal of any intervention is to maintain good vessel function as long as possible. In BIOLUX P-III, less than 9% of subjects required revascularization at two years in a complex patient population, representing a very promising outcome.”

Prof. Marianne Brodmann, Medical University of Graz, Austria, presented 12-month results of the ISR subgroup in infra-inguinal arteries (n=103), including SFA, popliteal and ‘Below the Knee’ (BTK) lesions. Reported results showed 90.1% FCD-TLR and 77.3% PP, with 88.8% of patients without any major adverse events (MAE).2

“You can’t treat in-stent restenosis like a ‘de novo’ lesion – naturally the presence of a stent from a previous intervention complicates the procedure,” commented Prof. Brodmann. “In these cases a drug-coated balloon is an important treatment option to minimize the burden on the vessel. These results show that we can treat ISR effectively while leaving nothing behind.”

BIOLUX P-III is a large ‘real world’ registry with 882 subjects enrolled across 47 study sites. Further analyses of a range of subgroups at 12 and 24 months are available or under preparation.

“The data presented at CIRSE provide an important insight into the role of DCBs,” said Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. “The study shows that Passeo-18 Lux can achieve outcomes which result in fewer patients needing re-intervention even two years after the procedure.”


1 Binkert C, SFA: Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries. 24-month results of the BIOLUX P-III All Comers Registry in Superficial Femoral Arteries, Presented at CIRSE, Lisbon, September 2018.

2 Brodmann M, ISR: Real-world experience with a paclitaxel-coated balloon for the treatment of atherosclerotic infrainguinal arteries: Twelve-month results of the BIOLUX P-III full cohort in in-stent restenosis, Presented at CIRSE, Lisbon, September 2018.



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.