San Francisco, California, USA, November 10, 2011 – Six-month results from the DELUX registry and 12-month results from the PEPPER study, both demonstrating excellent safety and efficacy results for the Pantera Lux Paclitaxel Releasing Balloon, were presented on Tuesday and Wednesday at the Transcatheter Cardiovascular Therapeutics (TCT 2011) conference by Dr. Ralph Toelg, MD, Segeberger Heart Center Clinic, Bad Segeberg, Germany, and Prof. Christoph Hehrlein, MD, University Medical Center, Freiburg, Germany, respectively.
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 semicompliant 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.
DELUX is a prospective, multicenter, nonrandomized, international registry evaluating the Pantera Lux Paclitaxel Releasing Balloon, originally in 601 patients in a real-world setting, a scope which was then amended to include 1,000 patients. The primary endpoint was the 6-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 1 and 12 months.
The DELUX 6-month outcomes confirm outstanding safety and efficacy with low revascularization and myocardial infarction (MI) rates with cumulative major adverse coronary events (MACE) rates were low for both the total cohort as well as the 10% of de novo lesions treated with 10.5% and 10.7% respectively.
“The Pantera Lux has proven an invaluable tool for the difficult-to-treat ISR lesions where conventional therapy options reach their limits,” commented Dr. Ralph Toelg. “This device is very deliverable and easy to use compared with other technologies and therapy options on the market addressing such types of challenging lesion subsets.”
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 MACE rates at 1, 6 and 12 months; in-segment late luminal loss; and percent diameter restenosis and binary restenosis at the 6-month follow-up.
The PEPPER 12-month outcomes are very favorable in a challenging in-stent restenosis (ISR) patient population, with clinically driven revascularizations necessary in only 9.2% of the target lesions. This confirms the positive results seen at six months where the study’s primary endpoint of in-stent late lumen loss of 0.07 mm showed effective inhibition of neointimal proliferation in all patients including the 47% who suffered restenosis from drug-eluting stents.
“These extremely favorable outcomes demonstrate success in both ISR and de novo lesions with the emerging drug-eluting balloon technology,” remarked Alain Aimonetti, Vice President of Sales and Marketing, BIOTRONIK Vascular Intervention. “This confirms that we are on the right path expanding our Lux clinical study program with a randomized controlled trial in ISR lesions and multiple trials in other indications including lower limb treatment.”
About BIOTRONIK SE & Co. KG
As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of over 5,600 employees. Known for having its finger 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 to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.