Data Presented on Biotronik's Passeo-18 Lux DCB and Pulsar-18 BMS

January 25, 2017—Biotronik announced that interim data on the efficacy of the company's dedicated lower limb intervention portfolio were presented during a scientific symposium at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany.

Investigators analyzed the combination of the Passeo-18 Lux drug-coated balloon (DCB) with the Pulsar-18 bare-metal stent (BMS) as part of the Biotronik REACT (Response Adapted Combination Therapy) treatment for superficial femoral artery (SFA) disease. The company stated that its REACT approach allows physicians to effectively treat the SFA with full-lesion paclitaxel coverage offered by a DCB and either spot or full-lesion stenting, depending on the lesion response to an initial angioplasty.

Jos van den Berg, MD, the symposium’s moderator, commented in the Biotronik's press release, “Currently available clinical evidence shows that the Passeo-18 Lux DCB has similar efficacy to drug-eluting stents when used standalone or in combination with the Pulsar self-expanding BMS. One crucial advantage of using a DCB with the Pulsar BMS in the SFA, 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.”

At LINC 2017, Biotronik reported that:

• Koen Keirse, MD, presented the latest interim data on 203 patients from the SFA cohort of the BIOLUX P-III registry, which is investigating the Passeo-18 Lux in an all-comers population. The data demonstrated 12-month primary patency of 82.1% and freedom from clinically driven target lesion revascularization of 94%. The bailout stenting rate within BIOLUX P-III was 14.5%. Additional data and subgroup analysis, including TASC D and heavily calcified lesions, are ongoing.
• Michael K. W. Lichtenberg, MD, presented data from the BIOFLEX PEACE all-comers registry that showed that the Pulsar-18 self-expanding BMS alone and in combination with a DCB continues to be an effective treatment option in the SFA. The primary patency rate of 74.3% and freedom from target lesion revascularization of 92.6% confirm the results shown in previous Pulsar studies.
• Koen Deloose, MD, presented interim data (90 of 120 patients) on the intentional combination approach using Passeo-18 plus Pulsar-18 from the multicenter, investigator-initiated BIOLUX 4EVER study. The findings demonstrated a primary patency of 88.9% at 12 months and a freedom from target lesion revascularization of 92.5%. Previously, the prospective, investigator-initiated DEBAS study showed a similar primary patency rate of 94.1% at 12 months.