GI Dynamics’ EndoBarrier non-surgical type 2 diabetes therapy receives CE mark approval

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.

For the full story, Click Here

AtriCure AtriClip System gets CE Mark approval

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.

Virtual Ports EndoGrab device receives CE Mark

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.

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.

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.

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.