Biotronik won European regulatory approval for its Passeo-18 Lux drug releasing balloon and the company is beginning commercial efforts in all CE Mark countries.
The Passeo-18 Lux is designed to treat de novo and restenotic femoropopliteal lesions with the drug paclitaxel. It is based off of the Passeo-18 percutaneous transluminal angioplasty catheter. The device allows for optimal drug transfer to the target lesion tissue.
Biotronik landed the approval in the European Union after the device showed successful results in a 2012 clinical trial. Trial patients treated with Passeo-18 Lux were less likely to require treatment again, according to a press release.
“The release of Passeo-18 Lux is a significant advancement for both physicians and patients, as DRBs are emerging as a safe and durable therapy option for lower limb arterial disease," Vascular Intervention sales and business development VP Alain Aimonetti said in prepared remarks. "Our significant investment in developing outstanding peripheral vascular devices, supported by clinical evidence, is translating into real clinical benefits."
The win is more good news for Berlin-based Biotronik, which recently inked a deal with the Veterans Affairs Administration to provide cardiac rhythm management devices to the organization, which serves 8 million veterans.