FREEWAY™ 014

Product catalog summary

Overview: The FREEWAY™ 014 is a drug-eluting PTA balloon technology specifically designed for infrapopliteal interventions. It features a unique coating of paclitaxel and shellac, proven for safety and efficacy in preventing restenosis and promoting smooth re-endothelialization.

Coating Characteristics: The balloon is coated with 3µg/mm² of paclitaxel in a 1:1 ratio with shellac. This amorphous bioshell coating ensures the drug is protected from mechanical abrasion and early wash-off, maintaining low paclitaxel blood plasma concentrations.

Mechanism of Action: Upon inflation, the balloon releases paclitaxel into the arterial wall, inhibiting smooth muscle cell proliferation and preventing restenosis. The hydrophilic shellac matrix swells in contact with body fluids, facilitating rapid drug release.

Product Features: The FREEWAY™ 014 offers several benefits, including local drug delivery, a non-crystalline coating for safety, and a low-profile design for smooth lesion crossing. It is suitable for lesions where stents are not viable and allows for re-intervention.

Balloon Characteristics: The device features an over-the-wire (OTW) PTA balloon catheter with a low crossing profile, short deflation time, and a wide range of balloon lengths (up to 150mm) for treating long, diffuse lesions. It has a coaxial catheter shaft design with kinking-resistant material.

Technical Data: The balloon is available in diameters from 2.0 to 4.0 mm and lengths from 40 to 150 mm. It has a semi-compliant characteristic with a nominal pressure of 6 atm and rated burst pressures of 14 to 16 atm, depending on the size.

Ordering Information: The product is available in various sizes with specific order numbers for different balloon diameters and lengths, suitable for introducer sheaths of 4 F.

Manufacturer Information: Eurocor Tech GmbH, a subsidiary of Opto Eurocor Healthcare Ltd, manufactures the device, which meets CE marking requirements.

Catalog excerpts

DRUG-ELUTING PTA BALLOON TECHNOLOGY SPECIFICALLY DESIGNED FOR INFRAPOPLITEAL INTERVENTIONS PROVEN SAFETY & EFFICACY 1, 2

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FREEWAY ™ 014 – DRUG-ELUTING PTA BALLOON TECHNOLOGY THE COATING MAKES THE DIFFERENCE FREEWAY ™ 014 – COATING CHARACTERISTICS ng/mL • 3µg/mm2 paclitaxel • Coating composition of shellac and paclitaxel (1:1 ratio) • Proven safety of coating 1, 2 level of no toxicity reaction Amorphous coating The durable non-crystalline bioshell coating homogenously covers the balloon surface and protects the drug from mechanical abrasion and early wash off, resulting in a low paclitaxel blood plasma concentration. Shellac is a natural resin composed of shellolic and alleuritic acid. The excellent film forming...

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FREEWAY ™ 014 – DRUG-ELUTING PTA BALLOON TECHNOLOGY SPECIFICALLY DESIGNED FOR INFRAPOPLITEAL INTERVENTIONS FREEWAY ™ 014 – ADVANCED PRODUCT FEATURES Concept benefits: Balloon characteristics: • Delivers drug locally over a short period of time • Over the wire (OTW) PTA balloon catheter for successful infrapopliteal interventions • Safety due to non-crystalline coating • Low balloon crossing profile • Low tip entry profile • Crosses lesions smoothly due to the low profile • Short deflation time • Treats lesions where stents are not a viable solution • Wide spectrum of balloon catheters for treating...

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FREEWAY™ 014 - DRUG-ELUTING PTA BALLOON TECHNOLOGY SPECIFICALLY DESIGNED FOR INFRAPOPLITEAL INTERVENTIONS Eurocor Tech GmbH Eurocor Tech GmbH is a wholly owned subsidiary of Opto Eurocor Healthcare Ltd and is part of the Opto Circuits Group. The device fulfils the requirements for CE marking - Notified Body 1434.

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FREEWAY™ 014

FREEWAY™ 014

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