BioPath 035

BioPath 035

BioPath 035

Product catalog summary
Product Overview: The BioPath™ 035 is a paclitaxel-eluting balloon catheter designed for peripheral interventions, specifically above the knee. It offers excellent pushability, trackability, and crossability due to its low balloon profile and hydrophilic coating.
Indications: The device is indicated for de-novo lesions, restenosis after balloon and/or stent PTA, and pre- and post-dilatation in peripheral stent implantation.
Design and Features: The catheter features a unique shellac coating that delivers paclitaxel directly to the target lesion. It is available in various balloon diameters (4.0 to 8.0 mm) and lengths (20 to 150 mm), with catheter lengths of 80 cm or 135 cm. The recommended guide wire is 0.035”.
Mechanism of Action: The paclitaxel prevents restenosis by stabilizing microtubule formation, inhibiting cell division, and reducing the excretion of growth factors that mediate vascular smooth muscle cell migration.
Procedure: The balloon is inflated at 6 bar for at least 60 seconds to deliver paclitaxel through cracked plaque onto the vessel wall. The shellac and paclitaxel coating swells upon contact with blood, facilitating drug transfer.
Regulatory Information: The BioPath™ 035 is CE Mark approved but not available for sale in the United States and certain other countries. It is restricted to sale by or on the order of a physician.
Contact Information: Biosensors Europe SA, Switzerland, and Biosensors Interventional Technologies PTE LTD, Singapore, are the manufacturers.
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Catalog excerpts

BioPath 035-1

PACLITAXEL ELUTING PTA BALLOON CATHETER (OTW) Latest generation paclitaxel-eluting balloon for peripheral interventions Designed for above the knee interventions Latest generation paclitaxel-eluting balloon for peripheral interventions Ordering Information Balloon diameter (mm) BioPath 035 oers excellent pushability, trackability and crossability due to a low balloon prole, low tip entry prole and a hydrophilic coating on the distal shaft of the catheter. ™ BioPath 035, with its unique shellac coating, delivers a designated paclitaxel dosage where it matters most – across the target lesion. PACLITAXEL ELUTING PTA BALLOON CATHETER (OTW) S: 80 cm usable catheter length L: 135 cm usable catheter length BioPath 035 is indicated for: > De-novo lesions > Pre- and post-dilatation in case of peripheral stent implantation 1. Axel D.L. et al. Circulation 1997; 96:636-45 2. A. Posa et al. Catheterization and Cardiovascular Interventions 76:395–403 (2010) 3. Data on le BioPath™ 035 paclitaxel-eluting balloon catheter is CE Mark approved. CAUTION: e law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. BioPath is a trademark or registered trademark of Biosensors International Group, Ltd. All cited trademarks are the property of their respective owners. Les informations relatives à ce produit ne sont pas destinées aux professionnels de santé exerçant en France – Any information related to this product is not intended for health care professionals who practice in France. Not available for sale in the United States and certain other countries. © 2014 Biosensors International Group, Ltd. All rights reserved. BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD 36 Jalan Tukang Singapore 619 266 Tel: +65 6213 5777 Fax: +65 6213 5737 > Restenosis after realisation of balloon and /or stent PTA

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BioPath 035-2

e right reach Delivering the paclitaxel drug Immediately after the controlled PTA, injury to the vessel wall key pathways contribute to the formation of neointimal hyperplasia. Injury from cracking plaque can lead to narrowing of the lumen. e paclitaxel dose will act over the short term to inhibit cell re-growth. e BioPath™ 035 balloon coating With balloon dilatation, the injuries to the arterial wall initiate an inammatory reaction with an excretion of growth factors which trigger the onset of cell division and smooth muscle cell migration. e BioPath 035 balloon coating consists of a 1:1 mixture...

 Open the catalog to page 2

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