PEPPER Demonstrates Safety and Efficacy of Biotronik's Pantera Lux Balloon

April 4, 2011—Biotronik AG (Bülach, Switzerland) announced that 6-month results from the PEPPER study were presented by Prof. Christoph Hehrlein, MD, at the American College of Cardiology's (ACC) 60th annual scientific session in New Orleans.

The PEPPER study is a prospective, multicenter, nonrandomized, European, first-in-man clinical trial evaluating the safety and efficacy of the Pantera Lux paclitaxel-releasing balloon in 81 patients. Prof. Hehrlein is the study's clinical coordinating investigator.

The Pantera Lux paclitaxel-releasing balloon is used to treat restenotic coronary artery lesions after drug-eluting or bare-metal stenting. The device is based on the company's Pantera semicompliant balloon, coated with a matrix of antiproliferative paclitaxel and the biocompatible butyryl-tri-hexyl citrate excipient to enable optimal drug transfer to the target lesion tissue.

The primary endpoint of the PEPPER trial was 6-month in-stent late lumen loss. Major secondary outcomes are cumulative major adverse coronary event rates at 1, 6, and 12 months; in-segment late luminal loss; and percent diameter restenosis and binary restenosis at 6-month follow-up.

According to Biotronik, the 6-month results demonstrated a very low number of revascularizations and no cardiac deaths. The company noted that the outcomes in this challenging in-stent restenosis patient population are promising. Clinically driven revascularizations were necessary in 5.2% of the target lesions. The in-stent late lumen loss angiographic outcome of 0.07 mm proves successful inhibition of neointima formation, even for the 47% of patients whose lesions had previously been treated with a drug-eluting stent.

“These excellent outcomes challenge the less favorable results seen with other devices used for the treatment of in-stent restenosis, paving the way for this drug-eluting balloon to become the treatment of choice for this indication,” commented Prof. Hehrlein. “What makes the Pantera Lux unique is its great delivery performance; furthermore, the innovative lipophilic drug release matrix may be pivotal in the yet unmatched efficacy of the therapy.”

Supported by the PEPPER results, the company stated that it will expand the Pantera Lux study portfolio into multiple clinical trials, including the international, multicenter DELUX trial, which is evaluating the safety and efficacy of the device for in-stent restenotic lesions in more than 1,000 patients in a real-world setting. Biontronik has also announced plans to introduce this novel technology in a peripheral vascular indication later in 2011.