LINC 2018: BIOFLEX PEACE and BIOLUX 4EVER Support Concept of Low Metal Burden Therapies in the Superficial Femoral Artery

Data from multiple clinical studies including BIOLUX P-III, the world’s second largest all-comers DCB registry, shows excellent outcomes even in challenging patient groups. BIOFLEX PEACE and BIOLUX 4EVER support the Concept of Low Metal Burden Therapies in the Superficial Femoral Artery.

LEIPZIG, Germany and BUELACH, Switzerland, January 31, 2018 – During a BIOTRONIK-sponsored symposium chaired by Dr. Jos van den Berg, Professor of Interventional Radiology, Ospedale Regionale di Lugano, Switzerland, panelists demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce restenosis rates.

In the world’s second largest drug-coated balloon (DCB) registry—BIOLUX P-III—700 out of 882 patients within the all-comers cohort were treated with Passeo-18 Lux. A Primary Patency (PP) rate of 85.2 percent and freedom from clinically driven Target Lesion Revascularizarion (fcd-TLR) rate of 94.0 percent at 12 months1 was presented by Dr. Gunnar Tepe, Professor of Radiology, Institute of Radiology, Rosenheim, Germany.

For the all-comers registry BIOFLEX PEACE 2, which investigated the Pulsar-18 stent in femoropopliteal lesions in 154 patients, Dr. Michael Lichtenberg, Klinikum Arnsberg, Germany, presented the 24-month study outcomes for the first time. The registry demonstrated that physicians are becoming aware of the importance of low chronic outward force (COF) and its potential to reduce restenosis. The Pulsar stent with thin struts, low COF and reduced stent oversizing reports a primary patency rate of 86.2 percent and a fTLR rate of 97.1 percent at 12 months; 78.0 percent at 24 months and a fTLR rate of 92.4 percent.

BIOLUX 4EVER3 with 120 patients and evaluating the use of full-lesion coverage with a DCB followed by a bare metal stent (BMS), was presented by Dr. Koen Deloose, AZ Sint-Blasius Hospital, Dendermonde, Belgium. The systematic combination of Passeo-18 Lux and Pulsar-18 study devices generated a primary patency rate of 89.9 percent at 12 months in average lesion lengths of 8.3 cm. Dr. Deloose highlighted that Primary patency of 83.3 percent reported for 105 out of 120 patients at 24 months compares favorably to DES results of 83.5 percent4 and 74.8 percent reported in previous DES studies5.

Dr. Patrice Mwipatayi, Professor of Vascular Surgery, Royal Perth Hospital, Perth, Australia, introduced the REACT (REsponse Adapted Combination Therapy) pilot study to evaluate different imaging modalities in assessing the need for stenting following DCB treatment in SFA lesions. This will be a new genre of study designed to collect scientific data in order to support physician decision-making based on vessel response.

Dr. van den Berg concluded: “The emergence of drug-coated balloons has revolutionized SFA intervention by eliminating or reducing the need for permanent metallic implants. However, adjunctive stents are still required to scaffold the vessel wall. Adopting a reactive approach gives us the opportunity to reduce metal burden by only implanting the stent length that’s needed, while benefiting from the anti-proliferative effect of DCBs. This versatility is, for example, not possible with DES.”

“These exciting data supports our belief that the REsponse Adapted Combination Therapy (REACT) approach allows physicians to adopt a flexible, evidence-based approach for treating the SFA with minimal vessel burden,” commented Dr. Alexander Uhl, Vice President of Marketing, BIOTRONIK Vascular Intervention.



A global leader in cardio- and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring®; Pulsar, the world’s first 4 F compatible stent for treating long lesions; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.