New Orleans, LA, USA, April 4, 2011 – Six-month results from the PEPPER (Paclitaxel REleasing Balloon in Patients PresEnting with In-Stent Restenosis) study demonstrating a very low number of revascularizations and no cardiac deaths were presented on Sunday at the American College of Cardiology (ACC) conference by Professor Christoph Hehrlein, MD, University Medical Center, Freiburg, Germany and clinical coordinating investigator of the study.
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. The primary endpoint was 6-month in-stent late lumen loss. Major secondary outcomes are cumulative major adverse coronary event rates at 1 month, 6 months and 12 months; in-segment late luminal loss; and percent diameter restenosis and binary restenosis at the 6-month follow-up.
The 6-month outcomes in this challenging in-stent restenosis patient population are promising, with clinically driven revascularizations necessary in only 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 Professor 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.”
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—enabling an optimal drug transfer to the target lesion tissue.
“With the overwhelmingly positive results achieved we will further expand our Pantera® Lux Paclitaxel Releasing Balloon study portfolio into multiple clinical trials,” remarked Alain Aimonetti, Vice President of Sales and Marketing, BIOTRONIK Vascular Intervention. “This includes a significant highlight – the international, multicenter DELUX trial evaluating the safety and efficacy of the device for in-stent restenotic lesions in more than 1,000 patients in a real-world setting.”
Additionally, BIOTRONIK has announced plans to introduce this novel technology in a peripheral vascular indication later in 2011.
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As one of the world’s leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 5,600 employees. Known for having its fingers on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis and treatment to patient management. Quality, innovation and clinical excellence define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide.