Cardiosolutions, Inc. Receives FDA 510(k) Clearance for Dexterity™ Steerable Introducer
Co-Planar Steerable Introducer for Unrivaled Access to Cardiac Anatomy
WEST BRIDGEWATER, Mass., June 13, 2012 -- Cardiosolutions Inc., offering structural heart solutions for valvular heart disease, today announced that 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 trans-septal procedure and facilitating passage of therapies into the entire left atrium, left ventricle and associated heart structures. The Dexterity Steerable Introducer 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 inter-atrial septum.
Dr. Thomas Piemonte, Chief Medical Officer for Cardiosolutions and Director, Interventional Cardiovascular Medicine and Cardiac Catheterization Laboratory at the Lahey Clinic in Burlington Massachusetts stated, "The Dexterity Steerable Introducer permits unparalleled access to the heart chambers. We believe it is an ideal and essential tool for the interventional or electrophysiology physician who needs precise catheter placement with combined ease of use."
More info is available at www.cardiosolutionsinc.com.