Francis L. Shannon, M.D., who is a partner in SEMCVS and Director of CV Surgical Research and Quality Outcomes at Beaumont, commented, The MiCardia device implanted easily and conformed well to the patient’s mitral annulus. The complete D-shaped ring was used to reinforce a complex repair of a flail leaflet segment using minimally invasive techniques. We are excited to be participating in the DYANA Study and believe Dynaplasty technology will address a major weakness of current devices, namely their inability to deal with changes in valve shape and function after the initial repair procedure.
MiCardia Chief Executive Officer Paul Molloy commenting on the first US site to enter the study said, “This is a major milestone for MiCardia and we are grateful for Dr. Shannon’s expertise in helping develop this technology. The Dynamic Annuloplasty Activation study involves patients from Europe who receive a device capable of activation post-implant and patients from the US who receive a shape memory device that is not capable of activation. MiCardia received a 510(k) clearance on the non-active version of its Dynaplasty System in September 2008. Patient data from both the US and Europe will be submitted toward CE Mark of the company’s Dynaplasty devices this year. We expect to complete enrollment and submit six month follow up data from the DYANA Study in Q4 of 2009 as a prelude to European commercialization of the world’s first minimally invasive, beating heart valve repair system.”
MiCardia is developing Dynaplasty technology to address the treatment of structural heart disease. It is initially focused on mitral and tricuspid valve disorders and as a method of interrupting a major element in the onset and progression of heart failure.
