The Sapien Artificial Heart Valve of Edwards get Extra Indications by FDA
Before Oct. 19, 2012, patients with aortic valve stenosis who are eligible for surgery but at high risk for serious surgical complications or death were not allowed to use artificial heart valve. While after the day, they could use Sapien Transcatheter Heart Valve (THV) since the U.S. Food and Drug Administration (FDA) expanded the approved indication for the THV. This gives cardiovascular patients more options.
Aortic valve stenosis is a progressive and age-related disease. It might be caused by the calcium deposit on the aortic valve and lead to narrow in corresponding part which later weaken heart and might cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest. In 2011, FDA first approved the Sapien THV for inoperable patients. Patients with severe stenosis must need to replace their heart valve to restore normal blood flow. Patients who can 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.
With the Sapien THV, which is implanted without opening the chest or heart, patients are unnecessarily to undergo surgery. The device is compressed into a delivery catheter. And then 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 intervention might cause risk or complication. But if there are rare choices or equal risk, THV could serve as an alternative for some. 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.
In order to extend and full use of this technology, a series of clinical studies were conducted, including a comparison study between 348 surgical patients who received the Sapien THV and 351 similar patients who received aortic valve replacement (AVR) through open-heart surgery. In result, both groups had similar death rates at one month, one year, and two years after the procedures. Both methods have risks, such as the THV might cause artery dissection or perforation, and for stroke during the first month following the procedure, while AVR might has major vascular bleeding during the procedure.
The manufacturer of the Sapien THV is Edwards Lifesciences Corp., of Irvine, Calif.