BIOTRONIK, a leading manufacturer of cardio- and endovascular devices, announced the first implantation in the BIOLUX P-III All-Comers Registry today. The purpose of this prospective, multi-center study is to collect and assess safety and efficacy data on the Passeo-18 Lux Drug-Releasing Balloon (DRB) for the treatment of obstructive disease of the infrainguinal arteries. The study calls for enrollment of real-world patients, allowing inclusion of a diverse patient population with lesion characteristics not typically enrolled in clinical studies - in short, "all-comers" - providing evidence on the role of the Passeo-18 Lux in treating peripheral artery disease in all its complexity.
The registry aims to enroll at least 700 patients at 55 sites from 19 countries in Europe, Asia, Australia and the Pacific, making the results truly representative of real-world, standard clinical practice. The primary endpoints of the study are freedom from clinically-driven target lesion revascularization (TLR) within 12 months as well as freedom from major adverse events (MAE). This is measured as a composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically-driven TLR within six months after the index procedure. "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," commented Dr. Gunnar Tepe, coordinating clinical investigator, Klinikum Rosenheim, Germany.
Almost five percent of men and women between the ages of 44 and 74 suffer from occlusions of the peripheral arteries. Left unchecked, the disease can lead to limb amputation. In fact, it is estimated that peripheral occlusive vascular disease causes an estimated 60,000 amputations per year in Germany alone. This study aims to show that Passeo-18 Lux is an effective real-world solution to a pressing health problem. The emergence of the DRB as a safe and durable therapy for lower limb arterial disease will improve patients' quality of life.
"Based on positive results from the BIOLUX P-I and BIOLUX P-II randomized controlled trials, we can already confirm that the Passeo-18 Lux DRB is a safe and effective therapy option for above- the-knee arterial disease, and has also demonstrated positive results below-the-knee," commented Dr. Alexander Uhl, Vice President of Marketing, BIOTRONIK Vascular Intervention. "We are confident that these positive results will hold for this all-comers registry, which significantly expands the investigation into our balloon's capabilities."
About Passeo-18 Lux*
Passeo-18 Lux is a novel combination device for treating de novo and restenotic lesions in the infrainguinal arteries. Its design is based on that of the proven Passeo-18 uncoated balloon catheter, combined with a balloon coating containing a matrix of anti-proliferative 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 Pantera Lux, a clinically proven coronary drug-releasing balloon. Passeo-18 Lux also features a unique insertion aid, which improves ease of handling and protects the user and balloon coating from contact and damage. After use, the insertion aid can simply be peeled away.
*Not for sale in the USA.
The registry aims to enroll at least 700 patients at 55 sites from 19 countries in Europe, Asia, Australia and the Pacific, making the results truly representative of real-world, standard clinical practice. The primary endpoints of the study are freedom from clinically-driven target lesion revascularization (TLR) within 12 months as well as freedom from major adverse events (MAE). This is measured as a composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically-driven TLR within six months after the index procedure. "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," commented Dr. Gunnar Tepe, coordinating clinical investigator, Klinikum Rosenheim, Germany.
Almost five percent of men and women between the ages of 44 and 74 suffer from occlusions of the peripheral arteries. Left unchecked, the disease can lead to limb amputation. In fact, it is estimated that peripheral occlusive vascular disease causes an estimated 60,000 amputations per year in Germany alone. This study aims to show that Passeo-18 Lux is an effective real-world solution to a pressing health problem. The emergence of the DRB as a safe and durable therapy for lower limb arterial disease will improve patients' quality of life.
"Based on positive results from the BIOLUX P-I and BIOLUX P-II randomized controlled trials, we can already confirm that the Passeo-18 Lux DRB is a safe and effective therapy option for above- the-knee arterial disease, and has also demonstrated positive results below-the-knee," commented Dr. Alexander Uhl, Vice President of Marketing, BIOTRONIK Vascular Intervention. "We are confident that these positive results will hold for this all-comers registry, which significantly expands the investigation into our balloon's capabilities."
About Passeo-18 Lux*
Passeo-18 Lux is a novel combination device for treating de novo and restenotic lesions in the infrainguinal arteries. Its design is based on that of the proven Passeo-18 uncoated balloon catheter, combined with a balloon coating containing a matrix of anti-proliferative 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 Pantera Lux, a clinically proven coronary drug-releasing balloon. Passeo-18 Lux also features a unique insertion aid, which improves ease of handling and protects the user and balloon coating from contact and damage. After use, the insertion aid can simply be peeled away.
*Not for sale in the USA.
