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The U.S. Food and Drug Administration has approved a stent graftsystem that provides patients with small arteries the option ofless invasive surgery to repair their potentially life-threateningabdominal aortic aneurysm . An abdominal aortic aneurysm is a bulge in the part of the aortathat runs through the abdomen and divides into the arteries thatsupply blood to each leg. Over time, this bulge can become weak,and the force of normal blood pressure can cause it to rupture,which can be life-threatening. Aneurysms can be repaired through open surgery or less invasivelywith endograft repair using a stent graft otherwise known as anendograft. Endografts feature a tube typically made of plastic material thatis supported by a metal frame or stent. They are compressed into adelivery catheter, inserted into the femoral artery of the leg andthen threaded into position in the weakened portion of the arterywhere they are released. Once released, the endograft expandsagainst the wall of the aorta to redirect blood flow away from theaneurysm. Treatment with a stent graft depends on the patient's anatomy. Asmall number of people have blood vessels that are too small indiameter to accommodate typical endograft systems on the market. The Ovation Abdominal Stent Graft System (20 millimeter diameter),manufactured by TriVascular Inc., is not only small in diameter butit uses a narrower delivery system than any other marketedendograft -- 4.7 mm in diameter compared to 7 mm in diameter fortypical delivery catheters. "The unique construction of the 20-mm Ovation system allows it tofit into a narrower delivery catheter than other endograftscurrently on the market. FDA's approval of this product will enablesome patients with small blood vessels to be treated viaminimally-invasive surgery who did not previously have thisoption," said Christy Foreman, director of the Office of DeviceEvaluation in the FDA's Center for Devices and Radiological Health. The 20-mm Ovation system, approved by the FDA on Nov. 1, differsfrom traditional endografts in that a portion of the metal stent isreplaced with ring-shaped channels. After the device is in place inthe aorta, the channels are injected with a polymer, expanding theendograft against the aorta to create a seal. The 20-mm Ovation was approved as a Humanitarian Use Device (HUD),an approval pathway limited to those devices that treat or diagnosefewer than 4,000 people in the United States each year. To obtainapproval for humanitarian use, a company must demonstrate areasonable assurance that the device is safe and that its probablebenefit outweighs the risk of illness or injury. The company alsomust show that there is no comparable device available to treat ordiagnose the disease or condition. The FDA reviewed clinical data from a study of the Ovation stentgraft system, in which four participants were treated with the20-mm device. The data were considered relevant in evaluatingsafety and probable benefit for the HUD. Investigators monitored participants and conducted imaging studiesat one, six, and 12 months looking for complications such asmovement or kinking of the endograft, leaks in the seal between theendograft and the aorta, and aortic ruptures. The FDA also considered data from a study of an earlier version ofthe Ovation that supported the stent graft's long-term ability toseal off an abdominal aortic aneurysm. Serious adverse events were consistent with other endovasculargrafts and included blood and lymphatic problems, cardiac events,gastrointestinal problems, genitourinary problems, and pulmonaryproblems. Investigators will continue to track participants for complicationsand adverse events for five years. The FDA approved the 20-mm Ovation system for use in patients withiliac or femoral artery access of fewer than 7 mm and an aorta withan inner diameter between 15.5 mm and 17.4 mm. The 20-mm Ovationsystem is contraindicated for use in patients with an infectionthat threatens to infect the graft and in patients who haveallergies to the device materials. The Ovation stent graft shouldnot be used in patients who are unable to undergo the necessarypreoperative and postoperative imaging studies. Additional References Citations. The e-commerce company in China offers quality products such as Wire Bunching Machine , Wire Stranding Machine Manufacturer, and more. For more , please visit Wire Drawing Machine today!
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