FDAnews Device Daily Bulletin
Medical Devices / Commercial Operations

Essential Medicine Obtains CE Mark

July 29, 2016
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Essential Medicine’s Manta gained CE Mark clearance in the European Union.

The large bore vascular closure device improves access site management for large-bore interventions. It is designed to close punctures after cardiac catheterization procedures.

Closure of large bore femoral access sites has been associated with significant morbidity including long times to achieve hemostasis, extended procedure time, need for a vascular surgeon in the catheterization lab, delayed ambulation, higher rate of complications and higher total cost of care. — Tamra Sami

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