The US Food and Drug Administration (FDA) has granted 510(k) approval to Cardiosolutions' Dexterity Steerable Introducer.
The Dexterity Steerable Introducer is designed to simplify the cardiac trans-septal procedure and facilitates passage of therapies and catheters into the entire left atrium, left ventricle and associated heart structures through the inter-atrial septum..
Cardiosolutions chief medical officer Thomas Piemonte said, "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."
Cardiosolutions president and CEO Steven Tallarida said, "We now have a specialty introducer product that complements the development of the Mitra-Spacer, a potential blockbuster device that is intended to mitigate mitral regurgitation."
US based Cardiosolutions develops less invasive, percutaneous alternative to open heart surgical repair of the mitral valve.