First-in-Human Experience Presented for Cardiosolutions' Mitra-Spacer System

September 22, 2015—Cardiosolutions, Inc. announced the presentation of the first-in-human experience with the Mitra-Spacer system, an atraumatic, volume-adjustable, mitral valve therapeutic device. The presentation was made at the PCR London Valves conference, held September 20–22 in Berlin, Germany.

According to Cardiosolutions, the Mitra-Spacer system is intended to treat or bridge heart failure patients whose operative mortality risk for undergoing conventional open heart surgery is too high.

The company’s technology involves the use of a tethered, atraumatic, inflatable, volume-adjustable balloon placed between the anterior and posterior mitral valve leaflets via a transapical approach on the beating heart. The Mitra-Spacer system does not focus on the repair of various anatomic changes of the mitral valve but acts to fill the gap between the native leaflets, thus reducing mitral regurgitation, noted the company.

The implantation procedures were performed in selected compassionate-use patients by Olaf Wendler, MD, who is Professor of Cardiac Surgery at King's College Hospital in London, United Kingdom.

In the company’s press release, Prof. Wendler commented, “A unique design feature of this promising technology is the ability to modify the fill volume of the Mitra-Spacer system postprocedure. 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.”