PTA catheter FREEWAY™ AV
peripheralballoondrug eluting

PTA catheter
PTA catheter
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Area of the body
balloon, drug eluting
Total length (mm)

40 cm (16 in)

Balloon diameter (mm)

4 mm, 5 mm, 6 mm, 7 mm (0.2 in)


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 Shellac 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. Prospective Registry-Design • 33 lesions • DEB dilatation with mandatory predilatation • Planned follow-up by ultrasound: 3 months • St. Joseph Hospital Berlin


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