FREEWAY™

Product catalog summary

Overview: The FREEWAY™ Shunt Balloon Catheter is a high-pressure drug-eluting balloon (DEB) designed for the treatment of shunt stenosis, particularly in arteriovenous (AV) fistulas and shunt grafts. It utilizes a paclitaxel-eluting mechanism to prevent restenosis and promote smooth re-endothelialization after balloon dilatation.

Specifications:

Balloon Diameter: 4.0 to 8.0 mm
Balloon Length: 20, 40, and 60 mm
Usable Catheter Length: 40 cm
Guide Wire Diameter: 0.035" (0.89 mm)
Balloon Coating: Paclitaxel (3 µg/mm²) within a shellac matrix (1:1 ratio)
Balloon Material: Polyamide/Nylon
Nominal Pressure: 12 atm
Rated Burst Pressure: Up to 20 atm

Mechanism of Action: The catheter delivers paclitaxel to the arterial wall, inhibiting smooth muscle cell proliferation and preventing restenosis. The hydrophilic shellac matrix swells upon contact with body fluids, facilitating the release of paclitaxel.

Clinical Program:

German AV Registry: Low re-intervention rate of 11% among 22 patients.
Italian AV Registry: Longer time to re-intervention (7.6 months vs. 4.8 months with standard balloon).
Turkish AV Registry: Higher primary patency rate (65.4% vs. 34.6%) and longer fistula survival (9.81 months vs. 7.58 months).
Turkish AV Registry II: Higher primary patency rate at 6 months (96.9% vs. 20.3%) and longer median fistula survival (220 days vs. 152.5 days).

Ordering Information: The catheter is available in various sizes with specific order numbers for each configuration. It is designed with a bilumen design and is semi-compliant, suitable for use with introducer sheaths of 6F or 7F depending on the balloon diameter.

Technical Data: Manufactured by Eurocor Tech GmbH, the device meets CE marking requirements and is part of the Opto Circuits Group.

Catalog excerpts

SHUNT BALLOON CATHETER HIGH PRESSURE DEB FOR THE TREATMENT OF SHUNT STENOSIS FREEWAY ™ – Shunt DEB protects AV fistulas and shunt grafts from early resteno

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FREEWAY ™ – SHUNT BALLOON CATHETER THE COATING MAKES THE DIFFERENCE FREEWAY ™ 035 AV SHUNT – BALLOON CHARACTERISTICS ng/mL • High pressure balloon (rated burst pressure up to 20 atm) • 3μg/mm paclitaxel 2 level of no toxicity reaction • Coating composition of shellac and paclitaxel (1:1 ratio) • Proven safety of coating 1, 2 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. Paclitaxel is an active ingredient that inhibits...

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HIGH PRESSURE DEB FOR THE TREATMENT OF SHUNT STENOSIS The FREEWAY™ 035 DEB is a clinically proven therapeutical option for AV shunt patients • 4 AV registries show solid results • Reduces re-intervention • Preserves future treatment option 4 Duda S et al. “First experience with DCB in AV-fistulas." Presentation at LINC 2015 5 Troisi N et al. “Freeway paclitaxel-releasing balloons to treat recurrent stenosis of arteriovenous fistula in hemodialysis patients." Minerva cardioangiologica 2018 66(3): 233-237. 6 Cildag MB et al. “The primary patency of drug-eluting balloon versus conventional balloon...

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HIGH PRESSURE DEB FOR THE TREATMENT OF SHUNT STENOSIS Eurocor Tech GmbH is a wholly owned subsidiary of Opto Eurocor Healthcare Ltd and is part of the Opto Circuits Group. Eurocor Tech GmbH In den Dauen 6a, 53117 Bonn Germany The device fulfils the requirements for CE marking - Notified Body 1434.

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FREEWAY™

FREEWAY™

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