FDA Clears Cardiosolutions' Dexterity Steerable Introducer

June 13, 2012—Cardiosolutions Inc. (West Bridgewater, MA) announced that it has received 510(k) clearance from the US Food and Drug Administration to market the Dexterity steerable introducer.

The Dexterity is the company's next-generation structural heart access introducer and delivery conduit. The device is intended for the advancement and delivery of various cardiovascular catheters into the heart, including the left side of the cardiac anatomy through the interatrial septum. 

According to the company, the coplanar steerable introducer is designed to provide 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.