BIOLUX P-I Study of Biotronik's Passeo-18 Lux DCB Published

March 3, 2014—Biotronik announced that Dierk Scheinert, MD, et al published 12-month results from the BIOLUX P-I clinical study in the Journal of Endovascular Therapy (2015;22:14–21). 

BIOLUX P-I was a first-in-human evaluation of the safety and efficacy of the company’s Passeo-18 Lux drug-coated balloon (DCB) in treating de novo and restenotic femoropopliteal lesions. The prospective, international, multicenter, randomized controlled trial enrolled 60 patients at five centers in Germany and Austria. The positive results of the trial supported CE Mark approval of the device, which was achieved in December 2013. In January 2014, Biotronik announced the launch of the Passeo-18 Lux DCB in Europe.

According to Biotronik, data collected at 6- and 12-month intervals demonstrated that patients who were treated with the Passeo-18 Lux DCB were less likely to require additional procedures. At 6 months, these patients had significantly lower rates of late lumen loss (0.51 ± 0.72 vs 1.04 ± 1; P = .033) and binary restenosis (11.5% vs 34.6%; P = .048) compared to the control percutaneous transluminal angioplasty (PTA) group of patients. 

At 12 months, the rate of clinically driven target lesion revascularization was lower in the Passeo-18 Lux DCB group (16% vs 52.9%; P = .02) for the as-treated population. In addition, patients who underwent treatment with Passeo-18 Lux showed greater improvement in Rutherford class compared to baseline than those in the control group (72% vs 65.2%).

In the company’s press release, Dr. Scheinert commented, “The study has generated the positive clinical data required to prove the validity of Passeo-18 Lux as an efficacious therapy in the treatment of femoropopliteal vessels. With restenosis following treatment with standard PTA balloons as a significant issue, Passeo-18 Lux is proven to be an effective and durable treatment option in treating disease in the more challenging peripheral vascular anatomy.” Dr. Scheinert, who is with the University Hospital Leipzig in Leipzig, Germany, served as the Primary Investigator of the BIOLUX P-I trial.

Results from BIOLUX P-I are in line with other scientific data suggesting that DCB treatment is a viable option and has the potential to become the standard for treating femoropopliteal arteries, stated the company.

Biotronik advised that the results of the study are being used by the company as a foundation to further investigate Passeo-18 Lux in real-world populations, such as the BIOLUX P-III all-comers registry, which is currently enrolling patients in Europe and Asia Pacific. 

Biotronik stated that the design of Passeo-18 Lux is based on that of the company’s Passeo-18 uncoated balloon catheter, combined with a balloon coating containing a matrix of antiproliferative paclitaxel and butyryl-tri-hexyl-citrate, a biocompatible excipient to enable optimal drug transfer to the target lesion tissue. The device’s SafeGuard insertion aid improves ease of handling and protects the user and balloon coating from contact and damage.