Edwards Lifesciences Lands Sapien 3 IDE

Edwards Lifesciences (Irvine, CA) received Investigational Device Exemption (IDE) status from FDA regulators for its Sapien 3 transcatheter valve. Armed with the IDE, the company can launch a clinical trial of the device to determine its safety and efficacy.

In the past, efforts to land approval for cardiac implant trials has been a time-consuming task. In response to the fast conditional approval, the company thanked FDA regulators.

The upcoming trial will study the Sapien 3 valve for the treatment of severe symptomatic aortic stenosis in inoperable and high-risk patients. Up to 500 patients will be enrolled in the trial and will receive the device through one of several delivery techniques. Approved delivery techniques include a transapical route through a patient's ribs, a transfemoral approach through the legs and a transaortic approach through the chest. The company forecasts that its clinical study will have a 12-month composite endpoint compared to its previous valves under the same brand.

"We're very excited to have the opportunity to initiate a U.S. study of the Sapien 3 valve. This valve builds on the Sapien platform and provides new features designed to benefit patients and enhance ease of use, such as a lower profile, a fabric cuff intended to reduce paravalvular leak and new delivery systems," stated Larry Wood, vice president of transcatheter heart valves at Edwards.

The company recently announced that its second-quarter results were up but acknowledged that the sales of its first-generation Sapien product in the United States were slower than anticipated.