FDA approves expanded indication for Sapien XT and Sapien 3 transcatheter heart valves to cover aortic valve stenosis patients at intermediate risk.-Edwards LifeSciences

The FDA has approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves, from Edwards LifeSciences ,for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery. �This is the first time in the U.S. that a transcatheter aortic valve has been approved for use in intermediate risk patients,� said Bram Zuckerman, M.D., director of the division of cardiovascular devices at the FDA�s Center for Devices and Radiological Health. �This new approval significantly expands the number of patients indicated for this less invasive procedure for aortic valve replacement.�

Aortic valve stenosis increases with age as the aortic valve becomes narrow, causing the heart to work harder to pump enough blood through a smaller opening. It occurs in about three percent of Americans over age 75 and can cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), cardiac arrest or death. Patients with severe aortic valve stenosis generally need to have a heart valve replacement to improve blood flow through their aortic valve.

Traditionally, open-heart surgery has been the gold standard for aortic valve replacement in intermediate risk patients, but it involves a larger incision and longer recovery time than the minimally invasive procedure used to insert the transcatheter heart valve. About one-third of patients referred for open-heart surgery for aortic valve replacement fall into the �intermediate risk� category, which is defined as having a greater than three percent risk of dying within 30 days following surgery.