Data Presented for Biotronik's BIOFLEX PEACE and BIOLUX 4EVER Studies

April 27, 2017—Biotronik announced that data from the BIOFLEX PEACE all-comers registry and the BIOLUX 4EVER study were presented at the 2017 Charing Cross Symposium in London, United Kingdom.

In BIOFLEX PEACE, the company's Pulsar-18 bare-metal stent (BMS) yielded high primary patency at 12 months in a real-world setting. The BIOLUX 4EVER study of the Passeo-18 Lux drug-coated balloon (DCB) used in combination with the Pulsar 18 BMS showed numerically comparable results to drug-eluting stents (DES).

According to Biotronik, the 12-month results from BIOFLEX PEACE revealed findings for the entire patient cohort for the Pulsar-18 in the treatment of femoral popliteal lesions in a real-world setting. During the presentation at the Charing Cross Symposium, lead investigator Michael Lichtenberg, MD, highlighted the 73.6% primary patency and 96.2% freedom from clinically driven target lesion revascularization (TLR) in 164 patients at 395 days. “These results are in line with already published data for the Pulsar stent from controlled trials, thus confirming the stent’s efficacy for a broader range of patients and lesions,” commented Dr. Lichtenberg, who is from the Vascular Center Clinic in Arnsberg, Germany.

Koen Deloose, MD, of AZ Sint-Blasius in Dendermonde, Belgium presented the findings from the BIOLUX 4EVER trial. In BIOLUX 4EVER, physicians used the combination of the Passeo-18 Lux DCB and the Pulsar-18 BMS to treat superficial femoral artery lesions. The full 12-month (395 days) outcomes showed 86.9% primary patency and 91.6% freedom from TLR in a cohort of 120 patients.

In Biotronik's press release, Dr. Deloose commented, “The 12-month outcomes of the BIOLUX 4EVER trial indicate the value of a combined approach that provides physicians with more options and versatility when treating SFA lesions while achieving DES-like results. While DES is limited by the need to fully cover the lesion with a stent and fully treat the lesion with paclitaxel, the new combination approach of a DCB and BMS means that there is now the freedom to determine how much support is necessary based on each vessel’s unique anatomy and lesion characteristics for a more tailored approach. Following full lesion coverage with the DCB, if full lesion stenting is deemed necessary, we have the results of BIOLUX 4EVER to give physicians the confidence of a good outcome; should the physician decide to minimize the metal burden, partial (focal) stenting can be used, which is not an option with DES.”