BUELACH, Switzerland, May 25, 2010 – BIOTRONIK AG today announced the international launch for its new Pantera Lux Paclitaxel Releasing Balloon for the treatment of coronary in-stent restenosis.
The Pantera Lux is a balloon catheter coated with a matrix of proven paclitaxel and biocompatible carrier for treating coronary lesions that have occluded after the implantation of a stent. This treatment option allows for the application of an anti-proliferative drug to achieve a sustained reopening of the re-narrowed artery without leaving another stent or permanent device behind.
“Drug eluting stents are the standard treatment for in-stent restenosis, but carry with them limitations such as late stent thrombosis, prolonged dual antiplatelet therapy and the problem of re-intervention if restenosis occurs again,” said Ron Waksman, MD, Associate Director from the Washington Heart Center, USA. “In the future, drug eluting balloons can be used in a subset of lesions where drug eluting stents do not perform well, such as in bifurcated lesions and torturous or small vessels where scaffolding can be an obstruction.”
The BIOTRONIK drug eluting balloon (DEB) makes use of paclitaxel as an antiproliferative treatment due to its rapid uptake and prolonged retention. The absorption properties of the drug are further enhanced with the addition of an excipient, called butyryl-tri-hexyl citrate (BTHC), which acts as an agent to keep the paclitaxel micro-crystalline, a form that shows even faster uptake by the vessel wall. BTHC is a safe and well characterized compound used in other blood-related medical devices.
“The methodology in which the drug is maintained on the balloon surface will become a key factor in how effective the device is,” commented Prof. Christoph Hehrlein, MD, Director of Cardiac Catheterization at University of Freiburg, Germany and Principal Investigator of the PEPPER Study, a 80-patient single-armed, international study to assess the safety and efficacy of the Pantera Lux. “It’s a delicate balance of an adequate adherence of the drug to the balloon while still achieving the proper drug release at the lesion site. With the Lux device, the flexible balloon materials give it good trackability while sheltering the drug within the folds of the balloon.”
The Pantera Lux balloon was designed with the underlying Pantera balloon technology as the delivery device. BIOTRONIK’s Pantera balloon was released in 2008 and has developed in the market as one of the top performing balloon devices for treating coronary disease.
“We’ve done extensive studies in animal models to determine the most optimal combination of drug, excipient and dosage. From these studies we know that with a short application of 30 seconds, the drug can be measured in the tissue for up to 7 days,” said Vice President of Sales & Marketing, Alain Aimonetti. “We are confident that the Pantera Lux is a solid alternative for in-stent restenosis and possibly for other indications that physicians struggle with where the placement of a permanent device is not optimal.”
BIOTRONIK plans to release a drug eluting balloon on a 0.018’’ OTW platform for the treatment of superficial femoral artery disease later this year.
As one of the world’s leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 5100 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.