The US Food and Drug Administration said that while it has found the new heart valve developed by Edwards Lifesciences to be effective, there are concerns over its safety relating to other health issues.
FDA reviewers found that the Sapien heart valve reduced the one year mortality rate of patients, who underwent transcatheter aortic valve replacement (TAVR), by more than 20 percent. However they expressed concern that the valve increased the risk of neurological events, including stroke.
AdvertisementThe FDA's Circulatory System Devices panel will now decide on Wednesday whether to grant an approval to the valve which will be one of the first artificial heart valve that does not require any major surgery.
Stating that the device managed to meet its endpoint by displaying a superior survival rate, the reviewers nevertheless expressed concern over other safety issues. "Neurological adverse events remain an important safety consideration for this device and should be weighed by the Panel in their overall determination of safety and effectiveness for the SAPIEN device", they wrote in their report.