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


June 15, 2012

June 15, 2012 — Cardiosolutions Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Dexterity Steerable Introducer, a next-generation structural heart access introducer and delivery conduit. 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.

"The Dexterity Steerable Introducer is an exciting, versatile product that permits unparalleled access to the heart chambers. We believe it is an ideal and essential tool for the interventional or electrophysiology (EP) physician who needs precise catheter placement with combined ease of use," said Thomas Piemonte, chief medical officer for Cardiosolutions and director of Interventional Cardiovascular Medicine and Cardiac Catheterization Laboratory at the Lahey Clinic in Burlington, Mass.

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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