Enterprise Stent Delivery System

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Humanitarian Device Exemption (HDE)

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?ID=H060001
    Approval for the cordis enterprise vascular reconstruction device and delivery system. This device is intended for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of> 3 mm and : 4 mm. Wide-neck is defined as having a neck width > 4mm or a dome-to ...

Summary of Safety and Probable Benefit - Food and Drug ...

    https://www.accessdata.fda.gov/cdrh_docs/pdf6/H060001b.pdf
    The CORDIS ENTERPRJSE T M Vascular Reconstruction Device and Delivery System is a self-expanding, neurovascular stent and delivery system. It consists of the following components: * Vascular Reconstruction Device (VRD/Stent) * Delivery System A detailed description of each of the two components of the CORDIS ENTERPRISE T MFile Size: 604KB

Cordis Enterprise Vascular Reconstruction Device and ...

    https://weillcornellbrainandspine.org/clinical-trial/cordis-enterprise-vascular-reconstruction-device-and-delivery-system
    The Cordis ENTERPRISE Vascular Reconstruction Device and Delivery System is authorized by federal law as a Humanitarian Use Device (a designation for devices that will be used to treat fewer than 4,000 people a year) for use with embolic coils for the treatment of wide-necked, intracranial aneurysms.

Understanding Your Cerebral Aneurysm, - UCSF Radiology

    https://radiology.ucsf.edu/sites/radiology.ucsf.edu/files/import/filemanager/patientcare/neuro_interventional/ENT-05-001_Enterprise_Patient_Brochure.pdf
    Understanding Your Cerebral Aneurysm, Diagnosis and Treatment Options A Patient Information Guide for CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System

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.

A Self-expanding Nitinol Stent (Enterprise) for the ...

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3983530/
    Dec 31, 2013 · 12) Furthermore, the Enterprise stent's delivery system facilitates its navigation and placement. Reported rates for the inability to navigate or deploy the Neuroform stent are as high as 19.8%, compared with only 0-5% for the Enterprise. Despite recent improvements in the delivery system, the failure rate of the Neuroform has remained high.Author: Sung Tae Kim, Hae Woong Jeong, Young Gyun Jeong, Young Jin Heo, Jeong Hwa Seo, Sung Hwa Paeng

Enterprise Stent Implantation in the Treatment of Carotid ...

    https://clinicaltrials.gov/ct2/show/NCT02802072
    Jun 16, 2016 · Enterprise Stent Implantation in the Treatment of Carotid Artery Stenosis With Ischemic Stroke. ... Enterprise stent system (Johnson & Johnson (Shanghai) Medical Equipment Co.,Ltd., China) is a closed loop self-expanding stent system that is made of Ni-Ti alloy. It consists of a self-expanding stent and a delivery system.

Delivery system - Boston Scientific

    http://www.bostonscientific.com/en-EU/products/stents-vascular/innova-self-expanding-stent-system/delivery-system.html
    Stent delivery system. A tri-axial catheter shaft was designed to provide added support and placement accuracy; Deployment technique Proper deployment technique is critical to ensure predictable, controlled stent deployment - especially for 150, 180 and 200 mm stents.

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