St. Jude scores FDA, CE Mark approval for carotid guiding sheath

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St. Jude Medical has received FDA clearance and European CE Mark approval for its Strada carotid guiding sheath, a flexible tube through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries.

The Strada carotid guiding sheath, available in 80 cm and 90 cm working lengths, is engineered with five transition zones to provide flexibility on the distal end of the sheath, and support on the proximal end of the sheath, according St. Paul, Minn.-based St. Jude. The company also said its construction provides kink resistance for added confidence in navigating challenging anatomy.

“The Strada carotid Guiding Sheath is a versatile sheath that is particularly adaptable to the tortuous carotid anatomy,” said Theodore Schreiber, MD, specialist-in-chief, vice president of cardiovascular development and division chief of clinical cardiology at the Detroit Medical Center.

An estimated 350,000 people in the U.S. undergo either surgery or a procedure in which a stent is inserted to restore blood flow through the carotid arteries annually.