Limits uncertainty with its special dumb-bell balloon shape that assures controlled positioning for dilatation of prepunctured cerebral membrane.
The NeuroBalloon™ Catheter is designed for dilatation of prepunctured cerebral membrane fenestrations such as Endoscopic Third Ventriculostomies (ETVs).
- The dilatation of the membrane fenestration can be observed through the transparent silicone of the NeuroBalloon™ catheter allowing maximum control.
- This accurate positioning is especially important during ETVs to avoid damage to critical structures such as the basilar artery.
NeuroBalloon™ Kit includes:
- A 4 Fr (1.35 mm) catheter with integral female luer lock connector and attached transparent silicone double balloon.
- A 1 ml (1cc) syringe.
The NeuroBalloon™ Catheter is intended for dilatation of cerebral membrane fenestrations under direct or endoscopic visualization during intracranial procedures.
Do not use the NeuroBalloon™ Catheter for other indications than the ones specified in the instructions for use.
Warning: Not for intravascular use. Do not use in rigid neuro-tissues, such as dilatation of aqueducts stenosis or thick membranes of arachnoid cysts, since the balloon is not designed to withstand high pressure. If the dilatation of the target site is not successful with 1 ml of air, the tissue may be too rigid for this instrument. Over-inflation should not be attempted as it may damage the balloon; another technique should be used.
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Regulatory and Legal Information
Class III Medical Devices.
Integra NeuroSciences Implants (France) S.A.S.
2905 route des dolines
06921 Sophia Antipolis Cedex • FRANCE
Availability of these products might vary from a given country or region to another, as a result of speciﬁc local regulatory approval or clearance requirements for sale in such country or region.
• Consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.
• Non contractual document. Integra reserves the right, without prior notice, to modify the products in order to improve their quality.
• Warning: Applicable laws restrict these products to sale by or on the order of a physician.
Product mentioned in this document is CE class III.
Please contact Integra customer service should you need any additional information on devices classification. All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on Medical Devices, and its relatives, unless specifically identified as “NOT CE MARKED.”
NeuroBalloon is a trademark of Integra LifeSciences Corporation or its subsidiaries. Integra and the Integra logo are registered trademarks of Integra Lifesciences Corporation in the United States and/or other countries.
© 2016 Integra LifeSciences Corporation. All rights reserved. Last revision date: 09/2016. 0526445-1-EN
Document for use in Europe, Middle-East & Africa only
For complete product information, please see the Instructions for Use accompanying each product.