Biotronik has reported positive six-month results of Pantera Lux Paclitaxel Releasing Balloon from Delux study.
The multicenter, prospective study, which enrolled 1064 patients with in-stent restenosis (ISR) or diabetes, was designed to study the safety and effectiveness of Pantera Lux Balloon.
The in-stent restenotic patients (87.7%) had a low major adverse cardiac event rate of 8.7% and a revascularization rate of 3.2%, while diabetic subgroup of 363 patients showed similarly low revascularization rates of 4.4%.
Segeberger Heart Center Clinic MD Ralph Toelg said seeing the low event rates in such a high-risk patient group in the Delux study suggests that the Pantera Lux can be a viable alternative for ISR and diabetes patients.
"The data suggests that treatment with the Pantera Lux Paclitaxel Releasing Balloon is highly promising for DES restenosis and especially encouraging in patients with a previous bare metal stent, where we see a very low revascularization rate of 1.7%," Toelg added.
The Pantera Lux Paclitaxel Releasing Balloon is coated with a matrix of proven antiproliferative paclitaxel and the biocompatible butyryl-tri-hexyl citrate (BTHC) excipient, which enables an optimal drug transfer to the target lesion tissue.