Positive Results for Paclitaxel-Eluting Balloon Seen in Both Diabetic, Non-Diabetic Groups


October 31, 2012
Pantera Lux Paclitaxel Releasing Balloon Biotronik

October 31, 2012 — Twelve-month results from the Delux registry demonstrated excellent safety and efficacy of the Pantera Lux paclitaxel-eluting balloon in treating coronary artery disease in 1,064 patients. The data were presented by Gert Richardt, M.D., Segeberger Heart Center Clinic, Germany, and Christoph K. Naber, M.D., Elisabeth Hospital, Germany, at the Transcatheter Cardiovascular Therapeutics (TCT) 2012 congress in Miami.

The registry enrolled a population of mostly in-stent restenotic patients (86.3 percent) who had a very low major adverse cardiac event (MACE) rate of 13.7 percent and a revascularization rate of 5 percent. A further analysis of the diabetic subgroup of 363 patients showed similarly low revascularization rates of 6.2 percent.

“The use of drug-eluting balloons in difficult to treat lesions — as documented in the Delux registry — can result in a substantial benefit for patients with limited further treatment options. This 12-month clinical endpoint provides us useful insight into their mid-term outcomes and more confidence selecting the right patient and lesion for this exciting new therapy option,” remarked Richardt.

The Pantera Lux Paclitaxel Releasing Balloon is a novel treatment for restenotic coronary artery lesions after drug-eluting or bare metal stenting. The device is based on the highly deliverable Pantera semi compliant balloon, which is then coated with a matrix of proven antiproliferative paclitaxel and the biocompatible butyryl-tri-hexyl citrate (BTHC) excipient and enables an optimal drug transfer to the target lesion tissue.

Delux is a prospective, multicenter, international registry evaluating the Pantera Lux Paclitaxel Releasing Balloon in 1064 patients in a real-world setting. The primary endpoint was the six-month cumulative MACE rate defined as a composite of all death, nonfatal myocardial infarction and clinically driven target vessel revascularization. Major secondary outcomes are cumulative MACE rates at one and 12 months.

Alain Aimonetti, vice president of Sales and Marketing, Biotronik Vascular Intervention, commented, “The positive results reinforce our commitment at Biotronik to expand investments into the drug eluting balloon therapy. We are currently exploring further indications such as coronary bifurcations and below the knee lesions with our broad Lux clinical program.”

For more information: www.biotronik.com