BIOTRONIK Announces First Implant in Global BIOLUX P-III All-Comers Registry, Expanding Safety and Efficacy Data on Passeo-18 Lux
Vascular Intervention / Success of the Passeo-18 Lux Drug-Releasing Balloon in Treating Peripheral Artery Disease to Be Assessed in Real-World Population
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.
One of the world's leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; the world's first 4 F-compatible 200 mm peripheral stent; Orsiro, the industry's first hybrid drug-eluting stent; and the world's first implantable cardioverter-defibrillators and heart failure therapy devices with ProMRI® technology.
For more information, visit: www.biotronik.com
Press releases you might also be interested in
Weitere Informationen zum Thema "Medizintechnik":
Mehrheit befürwortet KI-Systeme in der Polizeiarbeit
Laut einer Umfrage des Digitalverbands Bitkom befürworten rund sechs von zehn Bundesbürgern (61 Prozent) den Einsatz von Künstlicher Intelligenz (KI) zur Prognose von Straftaten. Die Polizei könnte so früher ihre Präsenz an potenziellen Tatorten verstärken.Weiterlesen