Microdelivery Stent System

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Stryker Neurovascular Neuroform EZ® Stent System

    https://www.strykerneurovascular.com/products/hemorrhagic/neuroform-ez-stent-system
    Flexible design. Enhanced delivery. The Neuroform EZ Stent System is comprised of a self-expanding Nitinol stent, pre-loaded on an enhanced Stent Delivery Wire. The Neuroform Stent is engineered for consistent conformability, flexibility, and accessibility.

Neuroform Microdelivery Stent System

    https://www.doctordoctor.biz/pdf/BostonScientific/Neuroform.pdf
    • The Neuroform Microdelivery Stent System has been shown to be MRI compatible in MRI systems operating at field strength of 1.5 Tesla or less. MRI laboratory evaluation demonstrated that no significant image distortion or heating was created by the presence of the stents at

Neuroform(TM) Microdelivery Stent System - H020002

    https://www.accessdata.fda.gov/cdrh_docs/pdf2/H020002c.pdf
    Title: Neuroform(TM) Microdelivery Stent System - H020002 Author: Author: ODE Subject: Issued: 09-11-2002 Keywords: Posted: 09-25-2002 Created Date

Neuroform EZ Stryker

    https://www.stryker.com/us/en/neurovascular/products/neuroform-ez-stent-system.html
    The Neuroform EZ Stent System is comprised of a self-expanding Nitinol stent, pre-loaded on an enhanced Stent Delivery Wire. The Neuroform EZ Stent System is authorized under a Humanitarian Device Exemption (HDE). IRB approval is required …

Humanitarian Device Exemption (HDE)

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/hde.cfm?start_search=1&productcode=NJE&applicant=STRYKER%20NEUROVASCULAR
    NEUROFORM ATLAS STENT SYSTEM: stryker neurovascular: H020002 S046: 11/02/2017: NEUROFORM MICRODELIVERY STENT: stryker neurovascular: H020002 S050: 02/07/2017: NEUROFORM MICRODELIVERY STENT SYSTEM: stryker neurovascular: H020002 S049: 10/05/2016: NEUROFORM EZ STENT SYSTEM: stryker neurovascular: H020002 S044: 09/11/2016: …

Boston Scientific Launches Neuroform EZ™ Stent System in U ...

    https://news.bostonscientific.com/news-releases?item=59255
    Boston Scientific will demonstrate its Neuroform EZ Stent System at the 7th Annual Society of NeuroInterventional Surgery (SNIS) Meeting, July 26 – 30 in Carlsbad, California. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.

Stryker Neurovascular MRI

    https://www.strykerneurovascular.com/hcp/mri
    Magnetic Resonance Imaging (MRI) ... Neuroform ® Microdelivery Stent System, Neuroform EZ ® Stent System. MRI Safety. Non-clinical testing and analysis have demonstrated that Neuroform Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neurovascular coil mass. A patient with Neuroform Stent can be ...

Magnetic Resonance Imaging (MRI) Stryker

    https://www.stryker.com/us/en/portfolios/neurotechnology-spine/neurovascular/embolization/test.html
    Neuroform® Microdelivery Stent System, Neuroform EZ® Stent System - MRI Safety Non-clinical testing and analysis have demonstrated that Neuroform Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neurovascular coil mass.

The Neuroform EZ Stent System, HUD - Orlando Health

    https://www.orlandohealth.com/clinical-trials-and-research/find-a-clinical-trial/0706909-the-neuroform-ez-stent-system
    The Neuroform Microdelivery Stent System consists of a Stent and a delivery system. The Stent is a permanent implant that is placed across the aneurysm neck. It is a tiny mesh tube that is made from a material called nitinol. The delivery system consists of catheters that are used to thread the Stent through your artery to the aneurysm neck.

Listing of CDRH Humanitarian Device Exemptions FDA

    https://www.fda.gov/medical-devices/hde-approvals/listing-cdrh-humanitarian-device-exemptions
    The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ...

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