FDA Publishes Further Information Following Approval Of Edwards Sapien Valve

As reported by medlatest, Edwards Lifesciences gained FDA approval to market its Sapien Transcatheter Aortic Heart Valve in early November.  FDA has now published follow-up information, in its words to provide; “a brief overview of information related to FDA’s approval to market this product.”

The FDA document can be found here and includes a Summary of Safety and Effectiveness Data (SSED) and product labeling, its indications for use, and the basis for FDA’s approval.

In a section entitled “How does it work?”, FDA explains its mode of action as follows;

“The device is inserted into the body by cutting a small opening in the artery carrying blood to the leg. The valve is placed on the end of a tube-like device called a balloon catheter, and is inserted into the opening in the leg. The catheter is pushed through the blood vessels until it reaches the damaged and/or diseased valve. The balloon on the end of the catheter is then blown up to expand the valve so it stays in place. Once the new valve is in place, it helps the blood flow properly by opening and closing like a door at the correct time to force the blood to flow in the correct direction.”

The Sapien Transcatheter Valve was CE marked in 2009.

Source: FDA