Epygon is the first “physiological” transcatheter mitral prosthesis; it can restore the natural blood flow vortex in the left ventricle, thereby fostering recovery of ventricular function, especially in fragile patients with a seriously impaired cardiac condition.
The device is in clinical development
The new Epygon bio-prosthesis for transapical mitral valve replacement has been designed to ensure superior clinical outcomes in patients with severe mitral regurgitation.
The unique features of the device include a pericardial tissue monoleaflet combined with a D-shaped annular ring. The asymmetric Nitinol frame, with its anatomic anchoring systems, ensures stable coupling below the mitral annulus, captures the native leaflets, and achieves optimal fitting with low risk of LVOT obstruction.
The Epygon design allows restoration of physiologic blood flow in the ventricle and through the aortic valve.
The natural asymmetry of the native valve generates a rotary flow or vortex in the ventricle that minimizes energy loss and helps propel blood directly into the aortic outflow tract.
Following insertion of a guide-wire through the apex, the Epygon Delivery System is advanced to ensure optimal central positioning inside the native mitral valve, using fluoroscopic and echo guidance.
In the first stage of delivery, the atrial portion of the device is gradually released immediately above the annular plane. Under 3D echo view, the atrial petals of the valve stent are deployed to obtain the desired D-shaped rotational position.
Under rapid pacing, the valve is now gently pulled towards the mitral annulus.
The ventricular anchoring systems of the stent are then released below the annulus while two engagement arms capture the posterior and anterior leaflets to prevent LVOT obstruction.
The Epygon transcatheter mitral valve prosthesis is able to restore physiologic blood flow within the ventricle while maintaining the native leaflets/tendinous chordae under traction to better preserve left ventricle function.
Affluent Medical is for the moment developing investigational medical devices not yet commercially available in any region.