Cardiosolutions Receives FDA 510(k) Clearance for Dexterity Steerable Introducer


June 15, 2012

Cardiosolutions Inc.'s Dexterity Steerable Introducer, a next-generation structural heart access introducer and delivery conduit, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in June 2012. The Dexterity Steerable Introducer is designed to provide physicians straightforward and uncomplicated access to the heart anatomy by simplifying the cardiac transseptal procedure and facilitating passage of therapies into the entire left atrium, left ventricle and associated heart structures. It is intended to be used for the advancement and delivery of various cardiovascular catheters into the heart, including the left side of the cardiac anatomy through the interatrial septum.

Transcatheter therapy of structural heart disease is advancing rapidly. Due to the less invasive approach, transcatheter techniques have replaced surgery as standard procedure for a number of complicated interventional procedures. Evolving interventional techniques allow treatment of rhythm disorders, paravalvular leaks, ventricular septal defects and valve replacement. Until recently, therapy for these diseases was limited to patients in whom severe comorbidities lead to contraindications to surgery.

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