FREEWAY Shunt Balloon Catheter High pressure DEB for the treatment of shunt stenosis
High pressure DEB
FREEWAY™ – Shunt DEB protects AV fistulas and shunt grafts from early restenosis
FREEWAY™ – Shunt DEB bioshell coating matrix
The FREEWAY™ shunt DEB is a clinically proven therapeutical option for AV shunt patients. The feasibility study presented at LINC 2015, showed a low re-intervention rate of 11% at follow up.
• For the treatment of AV fistulas
• Reduces re-intervention
• Preserves future treatment option
The excellent film forming properties of shellac are used to coat gastric resistant tablets.
The FREEWAY™ – Shunt DEB bioshell coating matrix consists of a natural resin, which is EMEA and FDA approved (GRAS) as food additive under E 904.
Neither direct contact to shellac-coated materials nor exposure to shellac extraction products impaired HDMEC and hSMC viability and function in vitro.
Shellac is a natural resin composed of shellolic and alleuritic acid.
The coating consists of a 1:1 mixture of Paclitaxel with shellac applied to the balloon by a micro-pipetting procedure in a clean room under sterile conditions.
• 33 lesions
• DEB dilatation with mandatory predilatation
• Planned follow-up by ultrasound: 3 months
• St. Joseph Hospital Berlin