The Food and Drug Administration in March approved the stent, which is a flexible tube that comes in a range of lengths and diameters. It can be used for a specific kind of aneurysm that pops out from the aorta -- the body's main artery.
The device has fewer deaths than surgical treatments, less blood loss, a shorter hospital stay and quicker recovery. Unlike open surgery, the stent can be implanted under local anesthesia.
It's also an option for elderly patients and others who would be unable to withstand the traditional surgery, which involves making a 12- to 14-inch-long opening in the chest and removing the diseased part of the aorta while the patient is kept alive on a heart-lung machine.
The device, manufactured by W.L. Gore and Associates Inc., of Flagstaff, Ariz., is made of Teflon-like material with an outer metallic support structure. It is the first
FDA-approved grafting system for treating aneurysms of the descending thoracic aorta.
Thoracic aortic aneurysms are diagnosed in approximately 15,000 people annually. Because they often cause no symptoms, they are typically spotted when a patient is being treated for another condition. If the aneurysm bursts, the person can quickly die of internal bleeding.
"The treatment options have been either open surgical repair or no repair at all," says Dr. Joseph Bavaria, a Penn cardiac surgeon and one of the lead investigators during trials of the device.
"We'd operate when the risk of rupture was greater that the risk of surgery ... or we put patients on blood pressure medication and hoped for the best," he adds
Penn is one of seven facilities nationwide training doctors about the device.
