Nov 3 2010
MiCardia Corporation announced today that it has received the CE Mark to begin marketing the Company's enCor™ Mitral Valve Repair System in the European Union.
“Obtaining the CE Mark approval for MiCardia's first product is a significant 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”
The enCor device offers unique benefits to patients and physicians during mitral valve repair surgery, a procedure to address mitral regurgitation, performed annually on thousands of patients worldwide. The enCor device provides a physician a device that can dynamically adjust the mitral value annulus to correct any residual mitral valve regurgitation intra-operatively, in real-time on a beating heart (off-bypass-pump). In the European Union approximately 20,000 mitral valve repair procedures are performed annually.
"Obtaining the CE Mark approval for MiCardia's first product is a significant 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," said Don Rohrbaugh, the company's Chief Executive Officer.
Samuel Shaolian, the Company's co-founder and Chief Technology Officer, said, "We thank the clinical investigators who participated in the Company's DYANA study that provided the clinical data that validate enCor's ability to reduce mitral valve regurgitation." He added, "Our next generation, enCorSQTM, 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. Many experts believe the enCor will be a breakthrough in the treatment of mitral valve disease."