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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
https://www.strykerneurovascular.com/products/hemorrhagic/neuroform-ez-stent-system
* The Neuroform® Microdelivery Stent System is authorized by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ≥ 2mm and ≤ 4.5mm that are not amenable to treatment with surgical clipping.
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
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 ...
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=91735
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.
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. ... Magnetic Resonance Imaging (MRI) Safety Information (Neurovascular Use)
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 …
https://news.bostonscientific.com/news-releases?item=59255
It employs Boston Scientific's proprietary Segmental™ Expansion technology, designed to enhance stent anchoring and stability. The product features the proven hybrid cell design of prior-generation Neuroform Stents while incorporating a simplified, single-operator delivery system intended to facilitate preparation, delivery and positioning of the stent.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/hde.cfm?start_search=1&productcode=NJE&applicant=STRYKER%20NEUROVASCULAR
Neuroform Atlas Stent: stryker neurovascular: H020002 S051: 02/09/2018: 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 ...
https://www.corcoranccg.com/products/faqs/istent/
Q What is the iStent ® trabecular micro-bypass system? A iStent ® is a small (1 mm X 0.33 mm) device designed to fit into Schlemm’s canal to facilitate aqueous drainage from the anterior chamber. It is made of non-magnetic, surgical grade titanium; it is coated with heparin and comes preloaded in an inserter.
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