Biotronik Begins the Global BIOLUX P-III All-Comers Registry

October 30, 2014—Biotronik announced the initiation of the BIOLUX P-III All-Comers Registry with the first patient implantation in the study, which will collect and assess safety and efficacy data on the company’s Passeo-18 Lux drug-releasing balloon (DRB) for the treatment of obstructive disease of the infrainguinal arteries. The prospective multicenter “all-comers” study is designed to provide evidence on the role of the Passeo-18 Lux in treating peripheral artery disease in all its complexity. The study will enroll real-world patients, allowing inclusion of a diverse patient population with lesion characteristics not typically enrolled in clinical studies.

According to the company, the BIOLUX P-III All-Comers Registry aims to make the results truly representative of real-world, standard clinical practice by enrolling at least 700 patients at 55 sites in 19 countries in Europe, Asia, Australia, and the Pacific. The primary endpoints of the study are freedom from clinically driven target lesion revascularization (TLR) within 12 months and freedom from major adverse events (MAE). MAE is measured as a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and clinically driven TLR within 6 months after the index procedure.

In Biotronik’s press release, Gunnar Tepe, MD, commented, “In the past, we relied on more specific studies with stringent sets of criteria to examine the effects of Passeo-18 Lux on patients suffering from peripheral artery disease. We are now looking forward to studying the way this DRB works in the real world.” Dr. Tepe, who is from the Klinikum Rosenheim in Germany, is the registry’s coordinating clinical investigator.

The company stated that the Passeo-18 Lux is a combination device for treating de novo and restenotic lesions in the infrainguinal arteries. The device’s design is based on Biotronik’s Passeo-18 uncoated balloon catheter. The balloon coating contains a matrix of antiproliferative paclitaxel and butyryl-tri-hexyl-citrate, a biocompatible excipient to enable optimal drug transfer to the target lesion tissue. This coating is also applied to the company’s Pantera Lux coronary drug-releasing balloon. Passeo-18 Lux also features an insertion aid, which improves ease of handling and protects the user and balloon coating from contact and damage. The insertion aid can be peeled away after use. The Passeo-18 Lux is not available for sale in the United States, advised Biotronik.