Biotronik's Technology Evaluated for Reduction of Metal Burden in SFA Treatment
January 31, 2018—Biotronik announced that data demonstrating that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce restenosis rates were presented during a company-sponsored symposium chaired by Jos van den Berg, MD, at LINC 2018: the Leipzig Interventional Course, held January 30 to February 2 in Leipzig, Germany.
Gunnar Tepe, MD, presented data from the BIOLUX P-III drug-coated balloon (DCB) registry. In the all-comers cohort, 700 of 882 patients were treated with Biotronik's Passeo-18 Lux and showed a primary patency rate of 85.2% and freedom from clinically driven target lesion revascularization (CD-TLR) rate of 94% at 12 months.
Michael Lichtenberg, MD, presented the 24-month study outcomes from the BIOFLEX PEACE registry, which investigated the Pulsar-18 stent in femoropopliteal lesions in 154 patients. The registry demonstrated that the device's low chronic outward force has the potential to reduce restenosis. The primary patency rate was 86.2% at 12 months and 78% at 24 months. The freedom from CD-TLR rate was 97.1% at 12 months and 92.4% at 24 months.
Koen Deloose, MD, presented the BIOLUX 4EVER data that evaluated the use of full-lesion coverage with a DCB followed by a bare-metal stent in 120 patients. The systematic combination of Passeo-18 Lux and Pulsar-18 study devices in average lesion lengths of 8.3 cm resulted in a primary patency rate of 89.9% at 12 months. Dr. Deloose noted that primary patency of 83.3% reported for 105 of 120 patients at 24 months compares favorably to results of 83.5% and 74.8% reported in previous drug-eluting stent studies.
Finally, Patrice Mwipatayi, MD, introduced the REACT (Response Adapted Combination Therapy) pilot study that will evaluate different imaging modalities in assessing the need for stenting following DCB treatment in SFA lesions. This will be a new genre of study that is designed to collect scientific data in order to support physician decision-making based on vessel response, noted the company.
In Biotronik's announcement, Prof. van den Berg concluded, "The emergence of DCBs has revolutionized SFA intervention by eliminating or reducing the need for permanent metallic implants. However, adjunctive stents are still required to scaffold the vessel wall. Adopting a reactive approach gives us the opportunity to reduce metal burden by only implanting the stent length that's needed while benefiting from the antiproliferative effect of DCBs. This versatility is, for example, not possible with drug-eluting stents."