Archive for the 'CE Mark' Category

Cryolife’s BioGlue receives CE Mark approval

CryoLife Inc.’s BioGlue Surgical Adhesive has received a CE Mark approval for its use in periosteal fixation that follows endoscopic browplasty (brow lift), a reconstructive procedure of cosmetic surgery. The product can now be marketed in the European Community (EU) by CryoLife’s partner BioForm Medical under the name “BioGlue Aesthetic(TM) Medical Adhesive. Commercial launch of BioGlue in the EU will follow after further clinical development is completed. However, the product will be available in Europe on a limited basis that will help in the evaluation and development program.

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.