MiCardia, a provider of mitral valve medical devices, has received the CE mark to begin marketing of the enCor Mitral Valve Repair System in the European Union.
The enCor device offers benefits to patients and physicians during mitral valve repair surgery, a procedure to address mitral regurgitation.
The enCor device provides physician a device that can adjust the mitral value annulus to correct any residual mitral valve regurgitation intra-operatively, in real-time on a beating heart (off-bypass-pump).
MiCardia CEO Don Rohrbaugh said that obtaining the CE mark approval for MiCardia’s first product is a milestone towards developing the company’s marketing infrastructure, which will be initially focused in the European Union.
“The enCor Mitral Valve Repair System has been presented and widely accepted in several EU medical meetings this past fall,” Rohrbaugh said.
MiCardia co-founder and chief technology officer Samuel Shaolian said that their enCorSQ will enable clinicians to dynamically adjust the device in a minimally invasive manner, to correct recurrent mitral valve regurgitation due to the progression of the underlying cardiovascular disease, weeks or months post implantation.