CIRSE 2016: Biotronik showcases positive results for lower limb intervention

Data establishes viability of BIOTRONIK combination therapy with Passeo-18 Lux drug-coated balloon and Pulsar-18 bare metal self-expanding stent presented at scientific symposium

BARCELONA, Spain and BUELACH, Switzerland – BIOTRONIK showcased the efficacy of its lower limb intervention portfolio yesterday at a scientific symposium at CIRSE 2016. Encouraging data were presented for the Pulsar-18 bare metal self-expanding (BMS SE) stent as well as for the Passeo-18 Lux drug-coated balloon (DCB), both stand-alone and together in combination treatment of superficial femoral artery (SFA) disease.

12-month interim results of BIOFLEX PEACE all-comers registry show that the Pulsar-18 BMS SE alone continues to be an effective treatment option in the SFA. The primary patency rate of 75.0 percent and freedom from target lesion revascularization (TLR) of 93.1 percent confirm the results of previous Pulsar studies.1,2 Meanwhile, 12-month data on the first 200 patients (of over 850 enrolled) in the BIOLUX P-III all-comers registry supports earlier findings3 in establishing Passeo-18 Lux DCB’s efficacy. The interim data showed a freedom from clinically-driven TLR of 94.0 percent.

Furthermore, “BIOTRONIK Combination Therapy” continues to show promise; this approach offers physicians the versatility to treat target lesions with a DCB in combination with a Pulsar BMS SE stent in segments where scaffolding support is required. Interim data from the BIOLUX 4EVER study for 90 patients demonstrated primary patency at 12 months of 88.9 percent, and a freedom from TLR of 92.5 percent. This is in line with data previously reported for BIOTRONIK Combination Therapy at the same analysis timepoint.4

“It is notable that the treatment of lesions with both Passeo-18 Lux DCB and Pulsar BMS SE during the same intervention leads to numerically similar patency rates for those obtained with drug-eluting stents” commented a lead investigator for the BIOLUX 4EVER trial, Dr. Koen Deloose, AZ Sint-Blasius in Dendermonde, Belgium. “It remains to be seen how this looks in the mid- to long-term, and also whether using DCB first or BMS first makes any difference with regard to clinical outcomes.”

“It is great to see BIOTRONIK devices continuously proving safety and efficacy when used either as a stand-alone treatment or combined,” stated Dr. Alexander Uhl, BIOTRONIK Vice President Marketing, Vascular Intervention. “We are particularly excited by the results of current BIOTRONIK combination therapy studies. We believe this approach allows physicians the flexibility to decide how much metal is necessary to leave behind: either full lesion coverage or only where support is needed. We very much look forward to presenting further data due in 2017 and beyond, from these and other running studies.”

About Passeo-18 Lux

Passeo-18 Lux is a novel combination device for treating de novo and restenotic lesions in the infrainguinal arteries. Its design is based on that of the proven Passeo-18 uncoated balloon catheter, combined with a balloon coating containing a matrix of anti-proliferative paclitaxel and butyryl-tri-hexyl citrate, a biocompatible excipient to enable optimal drug transfer to the target lesion tissue. This coating is also applied to Pantera Lux, a clinically proven coronary drug-coated balloon. Passeo-18 Lux also features the unique SafeGuard insertion aid, which improves ease of handling and protects the user and balloon coating from contact and damage. After use, SafeGuard can simply be peeled away.

About Pulsar-18

Pulsar stents feature an innovative, highly flexible design coated with proBIO, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility, which is believed to contribute to its excellent clinical results. Pulsar-18 is available in diameters of 4 to 7 mm, all deliverable through a 4 F sheath.

About Biotronik

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.


  1. Bosiers M et al. J Endovasc Ther. 2013, 20.
  2. Lichtenberg M et al. J Endovasc Ther. 2014, 21.
  3. Scheinert D, et al. J Endovasc Ther . 2015, 22 (1).
  4. Mwipatayi P. Self-Expanding Thin Strut Nitinol Stents (Pulsar) Plus DEBs: 2-Year Results from The DEBAS Trial Are Promising. Presented at: LINC 2017. NCT0187935

Source: Biotronik