FDA, EU approve St. Jude introducers

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St. Jude Medical has received FDA clearance and European CE Mark approval for the Engage and Engage TR sheath introducers.

St. Paul, Minn.-based company said that these introducers are designed to provide physicians with vascular access. The Engage introducer, designed for femoral access, includes 22 model configurations of varying sizes. The Engage TR, designed for transradial access, includes 18 model configurations.

The Engage family of introducers incorporates new features that were designed to minimize risks including bleeding, vessel trauma, vasospasm  or formation of blood clots within the introducer, St. Jude said.