Two-Year Data Presented From BIOLUX P-III Registry of Biotronik's Passeo-18 Lux DCB


April 18, 2019—Biotronik announced that 2-year data from the BIOLUX P-III all-comers registry of the company's Passeo-18 Lux drug-coated balloon (DCB) were presented at the Charing Cross Symposium, held April 15–18 in London, United Kingdom.

According to the company, the 24-month BIOLUX P-III registry data support the safe and effective clinical performance of the Passeo-18 Lux DCB for patients with infrapopliteal artery lesions and in-stent restenosis (ISR). The full BIOLUX P-III study cohort is composed of 882 enrolled patients.

At Charing Cross, Professor Gunnar Tepe, MD, presented the following 24-month data from a subgroup analysis of 151 patients with a total of 185 below-the-knee lesions treated with the Passeo-18 Lux DCB:

  • 20.3% rate of major adverse events
  • 91.4% freedom from clinically driven target lesion revascularization
  • 90.4% freedom from major target limb amputation

In the company's announcement, Prof. Tepe commented, “The outcomes support Passeo-18 Lux as a valuable treatment option for the infrapopliteal arteries. With ongoing discussions regarding paclitaxel use, we are looking forward to the long-term outcomes up to 5 years.”

Professor Marianne Brodmann, MD, presented the following 24-month results of 103 patients in BIOLUX P-III treated for ISR:

  • 27.3% rate of major adverse events
  • 78.6% of lesions were free from clinically driven target lesion revascularization

In a separate presentation, Prof. Brodmann revealed findings from a subgroup analysis focused on patients with lesions that required implantation of a bare-metal stent (BMS) after DCB (bailout stent group) compared to patients treated only with a DCB. The bailout stent group included more complex lesions: 31.3% TASC C and D lesions compared to 14.6% in the DCB-only group. With similar outcomes achieved for both primary endpoints in patients with more complex lesions, Prof. Brodmann concluded that a combination of Passeo-18 Lux and BMS is an effective way to treat long, heavily calcified or occluded lesions.

Finally, Mark Burket, MD, presented a detailed analysis of the Pulsar-18 and Astron Pulsar self-expanding stent chronic outward force (COF) in the femoropopliteal patient cohort of the BIOFLEX-I investigational device exemption trial. This first-in-human clinical data in the United States showed a trend that a high COF is linked to an increased restenosis rate in the superficial femoral artery at 12 months. The analysis suggests that a lower COF results in less restenosis and potentially fewer reinterventions, noted Dr. Burket.


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