LEIPZIG, Germany and BUELACH, Switzerland,

LINC 2017: Physicians Discuss Lesion Response-Adapted Therapies for Lower Limb Interventions

Interim Data on Efficacy of BIOTRONIK Passeo-18 Lux Drug-Coated Balloon and Pulsar-18 Bare Metal Stent Presented at BIOTRONIK Scientific Symposium

Physicians presented encouraging interim data on the efficacy of BIOTRONIK’s dedicated lower limb intervention portfolio during a scientific symposium at LINC 2017. Advantages of combining the Passeo-18 Lux drug-coated balloon (DCB) with the Pulsar-18 bare metal stent (BMS) were discussed as part of BIOTRONIK REACT REsponse Adapted Combination Therapy to treat superficial femoral artery (SFA) disease.

“Currently available clinical evidence shows that the Passeo-18 Lux drug-coated balloon has similar efficacy to drug-eluting stents when used standalone or in combination with Pulsar self-expanding BMS,” commented Dr. Jos van den Berg, Regional Hospital of Lugano, Switzerland, the symposium’s moderator. “One crucial advantage of using drug-coated balloon with Pulsar bare metal stent in the superficial femoral artery, however, is that it may reduce the metallic implant load due to its thin strut design. The REACT approach offers physicians versatility when deciding exactly how much metallic support is necessary, based on each vessel’s unique anatomy and lesion characteristics.”

BIOTRONIK’s REACT approach allows physicians to effectively treat SFA with full-lesion paclitaxel coverage offered by a DCB and either spot stent or full-lesion stenting, depending on the lesion response to an initial angioplasty. The latest interim data (203 patients) from the SFA cohort of the BIOLUX P-III registry, presented by Dr. Koen Keirse, Regional Hospital “Heilig Hart”, Leuven, Belgium, investigating Passeo-18 Lux in an all-comers population, demonstrated 12-month primary patency of 82.1% and freedom from clinically-driven target lesion revascularization of 94.0%.

The bailout stenting rate within BIOLUX P-III was 14.5%. Further data and subgroup analysis, including TASC D and heavily calcified lesions, are ongoing. In addition to the data from BIOLUX P-III, the BIOFLEX PEACE all-comers registry, presented by Dr. Michael K. W. Lichtenberg, Clinic Arnsberg, Germany, shows that the Pulsar-18 self-expanding BMS alone and also in combination with DCB continues to be an effective treatment option in the SFA. The primary patency rate of 74.3%1 and freedom from target lesion revascularization of 92.6% confirm the results shown in previous Pulsar studies.2, 3

Interim data (90 of 120 patients) on the intentional combination approach using Passeo-18 plus Pulsar-18, from the multi-center investigator-initiated BIOLUX 4EVER study, presented by Dr. Koen Deloose, A. Z. Sint-Blasius Hospital, Dendermonde, Belgium, demonstrated primary patency at 12 months of 88.9%, and a freedom from target lesion revascularization of 92.5%. Previously, the prospective, investigator-initiated DEBAS4 study showed a similar rate of primary patency at 12 months of 94.1%.

“BIOTRONIK’s REACT approach offers physicians the necessary tools to manage the challenges of treating SFA using our dedicated lower limb portfolio. It enables the lesions to be treated with versatility and confidence,” stated Dr. Alexander Uhl, BIOTRONIK Vice President Marketing, Vascular Intervention. “We are particularly excited by the promising results of current studies, including BIOFLEX PEACE, BIOLUX 4EVER and BIOLUX P-III. Furthermore we are keen to discover full primary endpoint data from these trials later this year.”



1 Imaging cohort.

2 Bosiers M et al. J Endovasc Ther. 2013, 20.

3 Lichtenberg M et al. J Endovasc Ther. 2014, 21.

4 Mwipatayi P. Self-Expanding Thin Strut Nitinol Stents (Pulsar) Plus DEBs: 2-Year Results from The DEBAS Trial Are Promising. Presented at LINC 2016. ClinicalTrials.gov: NCT0187935.


At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular and endovascular solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.