BUELACH, Switzerland, May 21, 2012 – Six-month results from the DELUX registry demonstrating excellent safety and efficacy results for the Pantera Lux Paclitaxel Releasing Balloon in more than 1000 patients were presented by Ralph Toelg, MD, Segeberger Heart Center Clinic, Germany, and Thomas Schmitz, MD, Elisabeth Hospital, Germany, at the EuroPCR 2012 congress in Paris last week.
The registry enrolled a population of mostly in-stent restenotic patients (87.7%), yet still had a very low major adverse cardiac event (MACE) rate of 8.7% and a revascularization rate of 3.2%. A further analysis of the diabetic subgroup of 363 patients showed similarly low revascularization rates of 4.4%.
“Patients with a complex disease such as in-stent restenosis (ISR) or diabetes represent a cohort that continues to return to the catheter laboratory with repeat restenosis. Seeing these low event rates in such a high-risk patient group in the DELUX study suggests that the Pantera Lux can be a viable alternative in these types of cases,” remarked Dr. Toelg. “The data suggests that treatment with the Pantera Lux Paclitaxel Releasing Balloon is highly promising for DES restenosis and especially encouraging in patients with a previous bare metal stent (BMS), where we see a very low revascularization rate of 1.7%.”
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, which 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 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.
Alain Aimonetti, Vice President of Sales and Marketing, BIOTRONIK Vascular Intervention, commented, “BIOTRONIK is continuing to build clinical evidence for the Lux drug-eluting balloon program. The excellent results across different indications strengthen our firm belief that the Pantera Lux can be a valuable tool outside of in-stent restenosis (ISR) and allow us to continue our exploration into other therapy areas.”
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