One problem with people is that parts wear out. Whether due to disease, trauma, or other causes, they can start to fail. Some parts can be repaired, but more and more, physicians are now able to insert replacements to take the place of the original equipment. Edwards Lifesciences Corporation is a leader in replacement heart valves, which have saved countless lives. There’s one major problem with most replacement heart valves, however; they require open heart surgery to be placed in the patient. And many patients are too frail or weak to survive such an invasive surgical procedure.
In response to this problem, Edwards has developed the SAPIEN XT replacement heart valve. The crown-shaped device in the photo can collapse into a tight cylinder. The valve itself is made of bovine tissue (from cows): the same tissue that Edwards uses for its surgical replacement valves. The collapsing feature means that the device gets small enough that it can be inserted into the body using a catheter, using a procedure similar to that used to insert expandable stents to open clogged blood vessels. The SAPIEN valve can be inserted into the patient’s heart and expanded by inflating a tiny balloon. This causes the valve to spring open, and it presses against the opening in the heart to remain in position.
The device has been approved for use in Europe for years, but in 2011, the FDA only approved the device for patients too old or too sick to tolerate traditional open heart surgery. Additional years of clinical testing will be required before the FDA will approve this less invasive approach for use with the general population.