FDA 510(k) Clearance For Cardiosolutions’ Dexterity™ Steerable Introducer

In short

Cardiosolutions Inc., calls itself “an emerging leader in structural heart solutions for valvular heart disease” and why not, because its mitral valve technology in development looks pretty smart. The company has announced that it has received FDA 510(k) clearance to market its Dexterity Steerable Introducer, a next generation structural heart access introducer and delivery conduit.


Cardiosolutions, Inc. is developing a less invasive, percutaneous alternative to open heart surgical repair of the mitral valve, which looks rather clever, albeit doesn’t yet have approval for sale. What it’s showcasing now, however is a device called the Dexterity Steerable Introducer System which simplifies cardiac trans-septal procedure and facilitates passage of therapies into the entire left atrium, left ventricle and associated heart structures.

When eventually paired with its Mitra-Spacer the system could provide a long-term therapeutic substitute to this complicated open heart valve repair procedure, representing a minimally-invasive solution to the nearly 200,000 patients diagnosed annually with moderate to severe mitral regurgitation who currently forgo treatment because they cannot tolerate a highly invasive procedure.

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.

Company comments

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 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 physician who needs precise catheter placement with combined ease of use.” Steven Tallarida, President and CEO of Cardiosolutions further offered, “The ability to generate revenue from our Dexterity Steerable Introducer, while simultaneously advancing the development of our Mitra-Spacer technology shows our ability to create value early in the startup cycle. 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.”

SOURCE Cardiosolutions, Inc., PRNewswire