The FDA’s approval of revised labeling for the Sapien Transcatheter Heart Valve will now provide greater access to of it to patients who have inoperable aortic valve stenosis.
Aortic valve stenosis is a narrowing of the valve between the left ventricle and the aorta that prevents normal blood flow. While the majority of people with mild to moderate aortic stenosis don’t generally have symptoms, an indication that a problem exists may be found in progressive shortness of breath during exertion.More severe indications symptoms include loss of consciousness (syncope), chest pain and sudden death.
While patients who are physically able to tolerate surgery usually undergo aortic valve replacement during open-heart surgery using a heart-lung machine to take over the function of the heart and lungs during the surgical procedure, the Sapien THV designed to be implanted in high risk patients without opening the chest or heart. Instead a thin flexible delivery catheter is inserted through the femoral artery in the leg up through the heart’s lower tip.
The new labeling now makes the device available for inoperable patients who need an alternate access point.