BIOTRONIK received European CE Mark approval to begin selling the Passeo-18 Lux Drug Releasing Balloon in the EU to treat new and reoccurring femoropopliteal lesions. Based on the Passeo-18 PTA (percutaneous transluminal angioplasty) catheter, it’s coated with paclitaxel to prevent tissue growth around the balloon.
Unlke the Passeo-18 PTA, the Lux device features a new protective insertion aid to help with manipulation and placement of the balloon.
From BIOTRONIK’s announcement:
Data collected at 6-month and 12-month intervals demonstrated that patients treated with Passeo-18 Lux were less likely to require treatment again.
BIOLUX P-I is a randomized, controlled study investigating the safety and performance of Passeo-18 Lux (n=30) versus an uncoated Passeo-18 PTA catheter (n=30) in the treatment of lesions in the femoropopliteal segment of up to 200 mm in length. The primary endpoint is late lumen loss in the Passeo-18 Lux arm versus the uncoated PTA (percutaneous transluminal angioplasty) catheter arm. Secondary endpoints include the Target Lesion Revascularization (TLR) rate and the Rutherford classification. The study enrolled patients at six centers in Germany and Austria.
Six-month primary endpoint data, evaluated by an independent core lab, previously documented significantly reduced angiographic late lumen loss (LLL) (p=0.038*) in the Passeo-18 Lux arm (LLL= 0.55 ± 0.73 mm) versus the uncoated PTA catheter (LLL= 1.07 ± 1.01 mm). Binary restenosis was also reduced (p=0.048*) in the Passeo-18 Lux arm versus the uncoated PTA catheter (11.5 percent vs. 34.6 percent respectively).
At 12 months, Kaplan-Meier estimates demonstrated a freedom from TLR rate of 84.6 percent for patients treated with Passeo-18 Lux versus 58.3 percent of patients treated with an uncoated PTA catheter (p=0.064). Furthermore, patients receiving treatment with Passeo-18 Lux demonstrated greater improvement in Rutherford classification compared to baseline (72 percent) versus those receiving treatment with PTA (65.2 percent).