Affluent Medical announces initial success of first clinical implantation of its Epygon mitral heart valve via minimally invasive route
This first implantation of the Epygon valve as part of the Mirvana pilot study was successfully performed by Prof. Stefano Salizzoni, MD, PhD.
Affluent Medical, a French MedTech specializing in the international development and industrialization of innovative medical prostheses, at a clinical stage, to treat mitral heart valve pathology and urinary incontinence, announced today the initial success of the first minimally invasive transcatheter implantation of its biomimetic Epygon heart valve in a patient in Italy as part of the Minerva pilot clinical study.
This first implantation of the Epygon valve as part of the Mirvana pilot study was successfully performed by Prof. Stefano Salizzoni, MD, PhD who is a co-investigator of the study along with his team at the Molinette Hospital of Health and Sciences of Turin in Italy. Importantly, Professor Marco Vola, cardiac surgeon at the HCL of Lyon was present as a surgical "Proctor" for Affluent Medical during the procedure.
The patient's health condition evolved favorably very rapidly. She is now in post-surgery rehabilitation care. The discharge visit showed a very good ultrasound result relating to the Epygon mitral valve function: no obstruction of the flushing chamber of the left ventricle, no regurgitation, no pressure gradient or paravalvular leakage. A follow-up visit is scheduled at one month post-operatively.
Professor Stefano Salizzoni, MD, PhD, Cardiac Surgeon at Molinette Hospital, Città della Salute e della Scienza in Turin - Italy stated: "We successfully implanted the Epygon valve in a patient with severe mitral regurgitation who could not be treated by open heart surgery due to numerous comorbidities. The team and I were very impressed with the ease and smoothness of the transcatheter implantation procedure, which avoids open heart surgery. From initial hands-on the Epygon transcatheter device to deploying the valve inside the patient’s heart, it took me only 15 minutes. The patient recovered quickly and was discharged from the hospital on day 5. She is now in cardiac functional rehabilitation."