Biotronik’s Pantera Lux balloon shows non-inferiority to stent treatment

Biotronik has announced new clinical data that demonstrates the clinical non-inferiority of its Pantera Lux drug-coated balloon.

Results from its BIOLUX RCT study compared the performance of the Pantera Lux balloon to current-generation sirolimus-eluting stents in the treatment of in-stent restenosis – the main indication for drug-coated balloons.

Study investigators found that Pantera Lux was angiographically non-inferior to stenting with the latest devices at six months, thus underlining the status of drug-coated balloons such as Pantera Lux as a viable alternative.

Dr Alexander Uhl, vice-president of marketing for Biotronik's vascular intervention division, said: "These encouraging results show that the Pantera Lux drug-coated balloon continues to be an excellent option for treating in-stent restenosis."

The balloon can also be used in the treatment of de novo lesions, small vessels and acute occlusions, and is coated with a matrix of the proven antiproliferative drug paclitaxel and the biocompatible excipient BTHC, enabling optimal drug transfer to the target lesion.

These new study findings build on previous single-arm clinical trials that established Pantera Lux as a safe and effective treatment for in-stent restenosis.