FDA Approves Device to Treat Aortic AneurysmsFDA Approves Device to Treat Aortic Aneurysms
Originally Published MDDI December 2004NEWSTRENDSFDA Approves Device to Treat Aortic Aneurysms
December 1, 2004
Originally Published MDDI December 2004
FDA Approves Device to Treat Aortic Aneurysms
The Zenith Flex is minimally invasive and allows more flexibility to follow the aortic vessel contours.
The only handmade device to treat a potentially fatal type of aneurysm has received FDA approval. The Zenith Flex AAA endovascular graft and H&L-B One-Shot introduction system, manufactured by Cook Inc. (Bloomington, IN), is a minimally invasive approach for treating abdominal aortic aneurysms. This condition affects more than 4 million people.
According to Cook, 90% of aortic aneurysms occur in the abdominal aorta. They are caused by a weakening of an area in the aorta, which upon blood flow, expands outward. A ruptured aneurysm can result in death from internal bleeding.
In endovascular grafting, a delivery catheter is inserted through the groin and into the abdominal aorta. The catheter tip has a deflated balloon and a polyester graft with metal hooks. The balloon is inflated, and the graft is opened to stop blood flow into the aneurysm.
Cook's Zenith Flex features a new endograft design with a modified stent configuration. “The graft was opened between the stents to allow more flexibility and to allow the graft to sit better in the aorta,” says Barry Thomas, global director of endovascular therapies division at Cook. The flexible qualities allow the device to follow the contours of the vessel, lowering the chance for any kinks.
The delivery system, which contains the Captor hemostatic valve and the Flexor introducer system, allows for more control of the graft. The valve also reduces blood reflux during the procedure. The doctors “partially deploy it and view it through an angiogram. They can move it to position it correctly,” says Thomas.
The new design addresses migration concerns that have plagued predecessor grafts. Migration occurs when an implanted device slides down. It can cause an endoleak, which can lead to an aneurysm. In clinical trials, the Zenith Flex had a 0% migration rate. “The bare-top stent has a suprarenal fixation, which hooks into the aorta to reduce the chance of migration,” says Thomas.
Because the device is handmade, it can be manufactured based on a patient's anatomy. “The doctor looks at a patient's workup and designs a graft based on available modules,” says Thomas. “It can be shipped overnight and used the next day for surgery.”
Thomas says that the company plans to make the endovascular graft available nationwide beginning in mid-November. The company hopes to launch the graft in Japan next year.
Copyright ©2004 Medical Device & Diagnostic Industry
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