By Mark Watson, Berlin, Germany

Cardiosolutions, Inc. today unveiled its first in-human experience with the Mitra-Spacer™ System. The presentation was made at the PCR London Valves conference in Berlin, Germany (September 20–22).

The Mitra-Spacer system is an atraumatic, volume-adjustable, mitral valve therapeutic device intended to treat or bridge heart failure patients whose operative mortality risk for undergoing conventional open heart surgery is too high.

Cardiosolutions' pioneering technology involves the use of a tethered atraumatic inflatable and volume adjustable balloon placed between the anterior and posterior mitral valve leaflets via a trans-apical approach on the beating heart. 

The Mitra-Spacer System does not focus on the repair of various anatomical changes of the mitral valve but acts to fill the gap between the native leaflets, thus reducing the mitral regurgitation.

The implant procedures were performed by Olaf Wendler MD, PhD, FRCS, Professor of Cardiac Surgery, King's College Hospital London, who commented:"A unique design feature of this promising technology is the ability to modify the fill volume of the Mitra-Spacer System post-procedure. This allows adjusting the mitral regurgitation therapy to the capacity of the left heart function and to eliminate residual mitral regurgitation in the long term course after implant."