Edwards Lifesciences, a provider in the science of heart valves and hemodynamic monitoring, has received CE mark for the Edwards SAPIEN pulmonic transcatheter heart valve.
Edwards Lifesciences said that the valve is designed to be an alternative to surgical valve replacement for patients suffering from congenital heart disease of the pulmonic valve.
Edwards SAPIEN pulmonic transcatheter valve’s leaflet design is modeled after Edwards’ aortic tissue valves and its stainless steel frame provides high radial strength. Prior to delivery, the bovine pericardial tissue valve is compressed onto a balloon to the approximate diameter of a pencil.
It is then threaded through the patient’s circulatory system using the RetroFlex 3 transfemoral delivery system, which enables accurate deployment of the valve across the patient’s pulmonary valve.
The valve is an investigational device currently being studied in the COngenital Multicenter trial of Pulmonic vAlve regurgitation Studying the SAPIEN InterventIONal THV (COMPASSION) clinical trial in the US, to assess the safety of the valve.
Edwards Lifesciences has completed the feasibility study of the valve and is progressing into the pivotal portion of the clinical trial with the goal of receiving a Humanitarian Device Exemption from the FDA.
Ziyad Hijazi, principal investigator of the study, said: “The Edwards SAPIEN pulmonic transcatheter heart valve gives clinicians the potential to eliminate one of the multitude of open-chest procedures that their young congenital heart patients will face in their lifetimes. As every re-operation increases a patient’s risk of infection, illness and death, it is a gift to have a minimally invasive way to treat these fragile patients.”
Larry Wood, corporate vice president, transcatheter valve replacement of Edwards, said: “We are proud to apply our extensive experience in heart valve innovation and leadership in transcatheter technology to provide a high-quality solution for patients with so many unmet needs.”