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Cardiosolutions, Inc. Receives FDA 510(k) Clearance for Dexterity™ Steerable Introducer
Date:6/13/2012

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. Cardiosolutions Dexterity™ Steerable Introducer simplifies many of these procedures and could provide lower cost, less invasive procedures leading to superior patient results.

About Cardiosolutions, Inc.
Cardiosolutions, Inc. ("Cardiosolutions" or the "Company") www.cardiosolutionsinc.com  is developing a less invasive, percutaneous alternative to open heart surgical repair of the mitral valve. The Dexterity™ Steerable Introducer System and Mitra-Spacer™ could provide a long-term therapeutic substitute to this complicated open heart valve repair procedure. In this connection, it would address the unmet clinical need for 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 Company is another novel medical device technology incubated within and spun out of STD Med, Inc. (Stoughton MA.) partnering with BioVentures Investors, a leading Medtech venture firm.  


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