Edwards Gets CE Mark for Sapien – Analyst Blog

Edwards Lifesciences (EW) recently received CE Mark for the Edwards SAPIEN pulmonic transcatheter heart valve. The company has designed the valve as an alternative to surgical valve replacement for patients suffering from congenital heart disease of the pulmonic valve. This device utilizes Edwards Lifesciences’ transcatheter valve technology, which has already been used in more than 5,000 cases worldwide.

According to medical practitioners, the Edwards SAPIEN pulmonic transcatheter heart valve, which is inserted through a minimally invasive procedure, offers clinicians the chance to eliminate multiple open-chest procedures that many congenital heart patients face during their lifetime.

The Edwards SAPIEN pulmonic transcatheter heart valve is designed like a leaflet, and is modeled after the company’s clinically proven aortic tissue heart valves, with its stainless steel frame providing superior radial strength. Prior to delivery, the bovine pericardial tissue valve is compressed onto a balloon to the diameter of a pencil. It is then threaded into position, using the RetroFlex 3 transfemoral delivery system, which enables accurate deployment of the valve across the patient’s pulmonary system.

The valve is an investigational device in the US. It is currently being evaluated in the COMPASSION (COngenital Multicenter trial of Pulmonic vAlve regurgitation Studying the SAPIEN InterventIONal THV) clinical trial, which is assessing the safety of the device. Edwards Lifesciences completed a feasibility study of the valve and is moving to the pivotal stage of the clinical trial, required to receive Humanitarian Device Exemption from the US Food and Drug Administration (FDA).