Positive results for Passeo-18 drug-coated balloon and Pulsar-18 bare metal stent in lower limb intervention

Final Press Releases
Passeo-18 Lux

Biotronik has showcased the efficacy of its lower limb intervention portfolio at a scientific symposium at CIRSE 2016 (10–14 September, Barcelona, Spain). Encouraging data were presented for the Pulsar-18 bare metal self-expanding stent as well as for the Passeo-18 Lux drug-coated balloon, both standalone and together in combination treatment of superficial femoral artery disease.

Twelve-month interim results of BIOFLEX PEACE all-comers registry show that the Pulsar-18 bare metal self-expanding stent alone continues to be an effective treatment option in the superficial femoral artery. The primary patency rate of 75% and freedom from target lesion revascularisation of 93.1% confirm the results of previous Pulsar studies. Meanwhile, 12-month data on the first 200 patients (of over 850 enrolled) in the BIOLUX P-III all-comers registry supports earlier findings in establishing Passeo-18 Lux’s efficacy, with interim data showing a freedom from clinically-driven target lesion revascularisation of 94%.

Final Press Releases
Pulsar-18 bare metal stent

A company press release also says that the “Biotronik Combination Therapy” continues to show promise. According to Biotronik, this approach offers physicians the versatility to treat target lesions with a drug-coated balloon in combination with a Pulsar bare metal self-expanding 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%, and a freedom from target lesion revascularisation of 92.5%. This is in line with data previously reported for Biotronik Combination Therapy at the same analysis timepoint.

“It is notable that the treatment of lesions with both Passeo-18 Lux and Pulsar 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, 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 drug-coated balloon or bare metal stent first makes any difference with regards to clinical outcomes.”