The U.S. Food and Drug Administration today expanded the approved indication for the Sapien Transcatheter Heart Valve (THV) to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.
The FDA first approved the Sapien THV in 2011 for patients with inoperable aortic valve stenosis, a progressive, age-related disease. Calcium deposits on the aortic valve that cause it to narrow are a common cause of aortic valve stenosis. As the heart works harder to pump enough blood through the smaller opening, it eventually weakens. Aortic valve stenosis can lead to fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest.
Those with severe aortic valve stenosis must have a heart valve replacement to restore normal blood flow. Patients who are in good enough health to tolerate surgery usually undergo open-chest, open-heart surgery or a minimally invasive surgery, in which surgeons gain access to the heart through an incision between the ribs.
The Sapien THV is implanted without opening the chest or heart. The device is compressed into a thin, flexible tube called a delivery catheter. The delivery catheter and the THV are inserted into the femoral artery through a small incision in the leg and threaded to the site of the diseased valve. The THV is then released from the delivery catheter and expanded with a balloon and is immediately functional.
“Any procedure to replace the aortic valve carries the risk for serious complications but for some patients with coexisting conditions or diseases that risk may be especially high,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health. “The THV serves as an alternative for some very high-risk patients.”
The Sapien THV is approved for those who have a calcium build-up in the fibrous ring of the aortic heart valve and are either not eligible for open-heart surgery or who are considered to be a very high-risk surgery patient by a cardiologist or thoracic surgeon. The approved product labeling advises that a heart surgeon should be involved in determining if the Sapien THV is an appropriate treatment for the patient.
The device is contraindicated (should not be used) for patients who cannot tolerate anticoagulation/ antiplatelet therapy.
Clinical studies to support the expanded approval included a clinical study of 348 surgical patients who received the Sapien THV and 351 similar patients who received aortic valve replacement (AVR) through open-heart surgery. Both groups had similar death rates at one month, one year, and two years after the procedures.
Those who received the THV showed an increased risk for major vascular complications, such as artery dissection or perforation, and for stroke during the first month following the procedure. Patients who received the AVR were more likely than the THV recipients to experience major vascular bleeding during the procedure
The manufacturer of the Sapien THV, Edwards Lifesciences Corp., of Irvine, Calif., will continue to evaluate the device through a national Transcatheter Valve Therapy registry, which facilitates the continued evaluation of transcatheter devices and procedures.
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