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December 23, 2013
08:30 EDTIARTIntegra LifeSciences complete enrollment in study of Integra template
Integra LifeSciences announced that it has completed patient enrollment in a multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Integra Dermal Regeneration Template to the standard of care for the treatment of diabetic foot ulcers. Integra Dermal Regeneration Template is an advanced bilayer skin replacement system designed to provide immediate wound closure and permanent regeneration of the dermis. The pivotal trial enrolled 307 patients at 32 sites, and all patients are followed for up to 28 weeks. Once patient follow-up is complete, which is expected to occur in mid-2014, this data will form the foundation for submission for Premarket Approval from the United States Food and Drug Administration (FDA). The PMA, if approved, along with publication of the data in a peer-reviewed journal, will support reimbursement for the product.
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April 15, 2014
09:23 EDTIARTBarclays medical supplies/devices analysts hold analyst/industry conference call
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April 4, 2014
08:36 EDTIARTIntegra LifeSciences receives FDA clearance for use of Camino catheter with MRI
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