Biotronik's Pantera Lux paclitaxel-releasing balloon has demonstrated safety and efficacy in treating restenotic coronary artery lesions after drug-eluting or bare metal stenting in the six-month study.
The highly deliverable Pantera semi-compliant balloon is coated with a matrix of proven antiproliferative paclitaxel and the biocompatible butyryl-tri-hexyl citrate (BTHC) excipient, which enables optimal drug transfer to the target lesion tissue.
The Pantera Lux coating technology allows the folded balloon to have a homogeneous coating of paclitaxel and excipient for increased bioavailability.
DELUX is a prospective multicentre international registry designed to assess the Pantera Lux paclitaxel releasing balloon in more than 1000 patients in a real-world setting.
The primary endpoint was the six-month cumulative major adverse cardiac event (MACE) rate, defined as a composite of all death, nonfatal myocardial infarction and clinically driven target vessel revascularisation, while the secondary outcomes included cumulative MACE rates at one and 12 months.
In the study, the in-stent restenotic patients showed a MACE rate of 8.7% and a revascularisation rate of 3.2%, while a diabetic subgroup of 363 patients showed revascularisation rates of 4.4%.
Ralph Toelg, Segeberger Heart Center Clinic, Germany, spokesperson, said the observed low event rates in a high-risk patient group in the DELUX study suggest that the Pantera Lux can be a viable alternative in these types of cases.
"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 (BMS), where we see a very low revascularisation rate of 1.7%," Toelg added.
Biotronik Vascular Intervention sales and marketing vice president Alain Aimonetti said: "The excellent results across different indications strengthen our firm belief that the Pantera Lux can be a valuable tool outside of in-stent restenosis (ISR) and allow us to continue our exploration into other therapy areas."
Image: The Pantera Lux paclitaxel releasing balloon is highly promising for drug-eluting stent restenosis and also benefits patients with a previous bare metal stent (BMS). Photo courtesy of: Biotronik.