SAN FRANCISCO–(BUSINESS
WIRE)–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 studys 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 worlds 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. More information: www.biotronik.com
