Designed for below the knee interventions
BioPath 014 is a drug-eluting balloon dilatation catheter designed for percutaneous transluminal angioplasty (PTA) and has been optimized for the treatment of patients with peripheral arterial disease.
BioPath 014 is intended for infrapopliteal interventions below the knee. This paclitaxel-eluting balloon feature a proprietary shellac coating technology which consistently delivers paclitaxel, an anti-restenotic drug during very brief inflation times, while also minimizing washout of the drug during delivery and placement of the drug-eluting balloon.
BioPath 014 balloon catheter offer excellent pushability, trackability and crossability due to a low balloon profile, low tip entry profile and hydrophilic coating on the distal shaft of the catheter.
The right choice
The treatment process
With balloon dilatation, the injuries to the arterial wall initiate an inflammatory reaction with an excretion of growth factors which trigger the onset of cell division and smooth muscle cell migration.
Paclitaxel prevents restenosis by stabilizing microtubal formation and thus prevents the cells going through the phases of replication, resulting in the inhibition of cell division.
Paclitaxel reduces the excretion of the platelet derived growth factor (PDGF) that mediates vascular smooth muscle cell migration to the intima.
The BioPath™ 014 balloon coating
The BioPath 014 balloon coating consists of a 1:1 mixture of paclitaxel (3 μg/mm2) and shellac, a natural resin approved by the FDA (GRAS), and by Europe (E904) as a food additive.
BioPath 014 delivers the designated concentration of paclitaxel locally to the arterial tissue.