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BioPath™ 014

Product catalog summary

Introduction
The document provides detailed information about the BioPath™ 014 paclitaxel-eluting balloon catheter, designed for peripheral interventions, specifically below the knee. It highlights the catheter's features, specifications, and the mechanism of action of paclitaxel in preventing restenosis.

Specifications
The BioPath™ 014 catheter is available in two usable lengths: 120 cm (L) and 150 cm (XL). It offers balloon diameters of 2.0, 2.5, 3.0, 3.5, and 4.0 mm, with lengths of 40, 80, 120, and 150 mm. The recommended guide wire size is 0.014”.

Design and Features
The catheter features a low balloon profile, low tip entry profile, and a hydrophilic coating on the distal shaft, enhancing pushability, trackability, and crossability. The unique shellac coating ensures effective delivery of paclitaxel to the target lesion.

Mechanism of Action
Paclitaxel prevents restenosis by stabilizing microtubule formation, inhibiting cell division, and reducing the excretion of platelet-derived growth factor (PDGF), which mediates vascular smooth muscle cell migration. The shellac and paclitaxel coating swells upon contact with blood, facilitating drug transfer.

Indications
The BioPath™ 014 is indicated for de-novo lesions, restenosis after balloon or stent PTA, and pre- and post-dilatation in peripheral stent implantation.

Usage Instructions
For effective drug delivery, the balloon should be inflated at 6 bar for at least 60 seconds. The shellac carrier remains on the balloon surface, ensuring paclitaxel is delivered through the cracked plaque onto the vessel wall.

Regulatory and Availability
The BioPath™ 014 is CE Mark approved but not available for sale in the United States and certain other countries. It is not intended for healthcare professionals practicing in France.

Catalog excerpts

PACLITAXEL ELUTING PTA BALLOON CATHETER (OTW) Latest generation paclitaxel-eluting balloon for peripheral interventions Designed for below the knee interventions PACLITAXEL ELUTING PTA BALLOON CATHETER (OTW) Latest generation paclitaxel-eluting balloon for peripheral interventions Ordering Information Balloon length (mm) BioPath™ 014 oﬀers excellent pushability, trackability and crossability due to a low balloon proﬁle, low tip entry proﬁle and a hydrophilic coating on the distal shaft of the catheter. BioPath 014, with its unique shellac coating, delivers the designated paclitaxel dosage where it matters most – across the target lesion. L: 120 cm usable catheter length XL: 150 cm usable catheter length BioPath 014 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 ﬁle BioPath™ 014 paclitaxel-eluting balloon catheter is CE Mark approved. CAUTION: ﬔe 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. © 2013 Biosensors International Group, Ltd. All rights reserved. BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE LTD > Restenosis after realisation of b

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ﬔe right choice Delivering the paclitaxel drug ﬔe treatment process 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. ﬔe paclitaxel dose will act over the short term to inhibit cell re-growth. ﬔe BioPath 014 balloon coating ™ With balloon dilatation, the injuries to the arterial wall initiate an inﬂammatory reaction with an excretion of growth factors which trigger the onset of cell division and smooth muscle cell migration. ﬔe BioPath 014 balloon coating...

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BioPath™ 014

BioPath™ 014

Catalog excerpts

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