Surgical Product Guide » CE Mark http://blog.surgicalproductguide.com A comprehensive guide to surgical products for medical professionals Wed, 05 Jan 2011 20:37:46 +0000 en hourly 1 http://wordpress.org/?v=3.1.3 GI Dynamics’ EndoBarrier non-surgical type 2 diabetes therapy receives CE mark approval http://blog.surgicalproductguide.com/2009/12/24/gi-dynamics-endobarrier-non-surgical-type-2-diabetes-therapy-receives-ce-mark-approval/ http://blog.surgicalproductguide.com/2009/12/24/gi-dynamics-endobarrier-non-surgical-type-2-diabetes-therapy-receives-ce-mark-approval/#comments Thu, 24 Dec 2009 06:46:42 +0000 admin http://www.surgicalproductguide.com/blog/?p=186 GI DynamicsGI Dynamics has announced that it has received European CE mark approval for the EndoBarrier(TM) a non-surgical therapy to treat type 2 diabetes and obesity. The CE marking certifies that a product has met EU requirements for marketing in Europe. Clinical trials involving more than 270 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.

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]]> http://blog.surgicalproductguide.com/2009/12/24/gi-dynamics-endobarrier-non-surgical-type-2-diabetes-therapy-receives-ce-mark-approval/feed/ 1 AtriCure AtriClip System gets CE Mark approval http://blog.surgicalproductguide.com/2009/10/09/atricure-atriclip-system-gets-ce-mark-approval/ http://blog.surgicalproductguide.com/2009/10/09/atricure-atriclip-system-gets-ce-mark-approval/#comments Fri, 09 Oct 2009 05:17:04 +0000 admin http://www.surgicalproductguide.com/blog/?p=140 AtricureAtriCure Inc, a medical device company and a leader in cardiac surgical ablation systems, gas received CE Mark approval for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion System. The AtriClip System is designed to safely and effectively exclude the left atrial appendage and is being launched in Europe through a phased approach during the fourth quarter. The system was successfully utilized this week in multiple European centers during both open-heart and minimally invasive cardiac procedures.

]]> http://blog.surgicalproductguide.com/2009/10/09/atricure-atriclip-system-gets-ce-mark-approval/feed/ 0 Virtual Ports EndoGrab device receives CE Mark http://blog.surgicalproductguide.com/2009/08/20/virtual-ports-endograb-device-receives-ce-mark/ http://blog.surgicalproductguide.com/2009/08/20/virtual-ports-endograb-device-receives-ce-mark/#comments Fri, 21 Aug 2009 04:27:01 +0000 admin http://www.surgicalproductguide.com/blog/?p=114 VirtualPortsVirtual Ports Ltd has obtained EU CE Mark for its EndoGrab device that reduces the number of incisions (or ports) needed to perform laparoscopic surgical procedures. EndoGrab is an internally anchored, hands-free retracting device that eliminates the need for the hand-held retractor that is traditionally used during laparoscopic procedures. This would reduce scarring and some of post-surgical complications associated with abdominal incisions.

]]> http://blog.surgicalproductguide.com/2009/08/20/virtual-ports-endograb-device-receives-ce-mark/feed/ 0 HyperBranch recieves CE Mark for NuSeal 100 http://blog.surgicalproductguide.com/2009/07/24/hyperbranch-recieves-ce-mark-for-nuseal-100/ http://blog.surgicalproductguide.com/2009/07/24/hyperbranch-recieves-ce-mark-for-nuseal-100/#comments Fri, 24 Jul 2009 05:08:53 +0000 admin http://www.surgicalproductguide.com/blog/2009/07/24/hyperbranch-recieves-ce-mark-for-nuseal-100/ HyperBranch Medical Technology Inc has received a CE Mark for its NuSeal 100 dural sealant product. NuSeal 100 is used in cranial neurosurgical procedures where a water tight seal is required on the dura. NuSeal 100 is intended for direct application on the dural surfaces to provide a positive seal after suturing thereby minimizing risks associated with post-surgical CSF leaks.

]]> http://blog.surgicalproductguide.com/2009/07/24/hyperbranch-recieves-ce-mark-for-nuseal-100/feed/ 0 St Jude Medical receives FDA and CE Mark approval for Strada Carotid Guiding Sheath http://blog.surgicalproductguide.com/2008/06/26/st-jude-medical-receives-fda-and-ce-mark-approval-for-strada-carotid-guiding-sheath/ http://blog.surgicalproductguide.com/2008/06/26/st-jude-medical-receives-fda-and-ce-mark-approval-for-strada-carotid-guiding-sheath/#comments Thu, 26 Jun 2008 20:48:37 +0000 admin http://www.surgicalproductguide.com/blog/2008/06/26/st-jude-medical-receives-fda-and-ce-mark-approval-for-strada-carotid-guiding-sheath/ StradaSt. Jude Medical Inc.has received approval from U.S. Food and Drug Administration (FDA) and European CE Mark for its Strada Carotid Guiding Sheath. The equipment is a flexible tube available in 80 and 90 cm working lengths through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries.

]]> http://blog.surgicalproductguide.com/2008/06/26/st-jude-medical-receives-fda-and-ce-mark-approval-for-strada-carotid-guiding-sheath/feed/ 0 DiscAssist gets CE Mark certification http://blog.surgicalproductguide.com/2008/03/12/discassist-gets-ce-mark-certification/ http://blog.surgicalproductguide.com/2008/03/12/discassist-gets-ce-mark-certification/#comments Wed, 12 Mar 2008 18:10:14 +0000 admin http://www.surgicalproductguide.com/blog/2008/03/12/discassist-gets-ce-mark-certification/ DiscAssistMazor Surgical Technologies has received CE Mark Certification for its DiscAssist guidance and positioning system for disc replacement surgery. DiscAssist helps doctors to plan the appropriate size and placement of artificial discs in interverteberal disc replacement surgery. The company aims at filing for FDA approval in the US and expected to receive the same by the end of 2008.

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