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March 10, 2010
St. Jude Medical's Engage Introducer Devices Approved
March 11, 2010—St. Jude Medical, Inc. (St. Paul, MN) announced US Food and Drug Administration clearance and European CE Mark approval for the Engage and Engage TR introducers for use in diagnostic and interventional cardiac catheterization procedures. The Engage family of introducers incorporates features that offer more control and minimize risks during access and throughout the procedure, the company stated.
According to St. Jude Medical, the Engage introducers are designed to provide femoral access to the vasculature, minimize trauma to the artery, and set the stage for the use of closure devices. The company's portfolio of Engage transfemoral introducers includes 22 model configurations of varying sizes to accommodate a wide variety of procedures. The Engage TR introducer portfolio includes 18 model configurations that facilitate transradial procedures.
“The new Engage family of introducers helps to set the stage for a successful procedure by reducing the number of potential variables that can affect patient outcome,” commented Javier Goicolea, MD. “Whereas some introducers were designed to just perform the basic access function, the Engage introducers were designed with the entire procedure in mind, including a successful closure.”
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