The U.S. Food and Drug Administration (FDA) this Wednesday approved the sale of Edwards Life Sciences Corp's Sapien heart valve for patients deemed too sick to have open-heart surgery.
The approval came after a 365 –patient clinical trial that found that patients receiving the Sapien valve experienced two and a half times more strokes and eight times as many vascular and bleeding complications than those who did not receive the implant, but they were more likely to survive one year after surgery. After a year, 69 percent of the Sapien patients were alive compared with 50 percent of those who received an alternative treatment.
About 300,000 U.S. patients suffer from deterioration of the valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. More than half of patients diagnosed with the condition, called aortic stenosis, die within two years, according to the FDA. Here the aortic valve that allows blood to leave the heart does not fully open, decreasing blood flow and potentially preventing it from reaching the brain and the rest of the body.
A bad aortic valve commonly requires open-heart surgery, during which the ribs are sawed open, the heart is stopped and a new valve is sewn in place. With an Edwards' Sapien transcatheter heart valve, a catheter guides the new valve to the heart through the femoral artery in the groin or a small incision between the ribs.
Cardiologists say the highly anticipated new approach will help old, sickly patients who cannot undergo the more invasive open heart surgery, which has been used to replace valves for decades.
The Mayo Clinic’s Dr. David Holmes said the Sapien valve is a “game changer” for those inoperable patients, many of whom are in their 80s with medical conditions like diabetes, emphysema and liver disease. “We don’t have very good therapy for them at this time — some of them receive palliative care and some receive medication,” said Holmes, who is president of the American College of Cardiology. “But this is really a mechanical problem, and for mechanical problems medications don’t work very well.”
The valve has already been approved for four years in 40 countries around the world, including most of Europe. Edwards has sold such a valve in Europe since 2007. The company estimated last month that its U.S. sales of the Sapien valve would total between $150 million and $250 million in the first full year after the product is launched. In most of those countries Edwards already sells a next-generation version of the device.
The device is expected to cost about $30,000, and will compete with a system developed by Medtronic Inc's CoreValve unit in Europe. The Sapien valve is made of cow tissue and polyester supported with a stainless steel mesh frame.
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