BLOOMINGTON, Ind.–(BUSINESS WIRE)–Cook Medical, the established world leader in developing advanced technologies to treat diseases of the aorta, announced the first commercial placement of its Zenith TX2® TAA Endovascular Graft in the United States. The groundbreaking procedure was performed on a 69-year-old male patient by Sean Lyden, M.D., a vascular surgeon and specialist in endovascular aneurysm repair (EVAR) practicing at a major medical institution in Cleveland, Ohio. Cook’s state-of-the-art aortic endograft is designed specifically to treat patients undergoing thoracic endovascular aortic repair (TEVAR) for descending thoracic aneurysms and ulcers.
“The first placement of the TX2 in the United States showcases the advanced medical technologies Cook brings to the marketplace and marks a step forward in treating a broad range of TAA patients, safely and effectively, worldwide,” said Phil Nowell, global leader of Cook Medical’s Aortic Intervention business unit. “Dr. Lyden and others have told us they’ve been eagerly awaiting this device because it deploys with such accurate control and is actively fixed to the aorta, unlike competing devices. We believe this is a dramatic improvement for patients in a section of the aorta that really challenges endovascular devices for durability and that frequently offers only limited surgical repair options.
“With the highly skilled support of vascular surgeons like Dr. Lyden, we are now able to serve U.S. patients affected by TAAs (thoracic aortic aneurysms) or ulcers with the most minimally invasive alternatives available. Cook’s TX2 can be used on an additional subset of patients who may have been ineligible for treatment through open surgery, giving those affected by the disease, the opportunity to be treated with TEVAR,” Nowell added.
“The commercial release of the TX2 really made a huge difference for this patient,” said Dr. Lyden. “Using a small groin incision we were able to accomplish repair of his aneurysm in about 45 minutes. The two-piece device allowed customization to the patient’s anatomy to sit perfectly at the level of the left subclavian artery proximally and distally to near the celiac artery and prior repair. The hydrophilic Flexor delivery system passed through his anatomy to the treatment area with remarkable ease. This device will clearly make a huge impact on treating thoracic aortic disease.”
TAAs occur when a section of the aorta weakens and bulges outward like a balloon. The Cook Zenith TX2, a reinforced fabric tube that is sized to the length of the aorta is used to seal off the aneurysm, where it helps to relieve pressure on the aneurysm or ulcer and reduce the risk of rupture. The Zenith TX2 device is deployed from a catheter inserted through a small incision in the patient’s femoral artery. This procedure is far less invasive than traditional open surgery where physicians open the patient’s chest, clamp off and remove the diseased section of the aorta and replace it with a surgical graft. Post-operative and post-discharge recovery times are typically shorter with TEVAR, which may help patients return to their normal lifestyle routines far faster than for those who undergo open surgery.
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Zenith Flex® AAA Endovascular Graft
The MR safety and compatibility of the Zenith® AAA Endovascular Graft (a previous version of the device) has been evaluated through bench testing in MRI systems with static fields of ≤1.5 Tesla, gradient magnetic fields of ≤20 Tesla/second and whole body averaged specific absorption rate (SAR) of 1.2 W/kg for 30 minutes of imaging. The Zenith® AAA Endovascular Graft was found to exhibit significant deflection and torque of the stainless steel metallic component of the endovascular graft and therefore did not meet standard ‘MR Safe’ bench test criteria.
Adverse events have not been reported clinically in patients who have undergone MRI. However, sufficient data are not available to demonstrate MRI safety and there may be potential risks (e.g., device migration, vessel damage) that could be associated with forces applied to the metallic components of the Zenith® AAA Endovascular Graft. Therefore, a careful assessment of these potential risks and the potential benefits to the patient should be completed prior to use of MR imaging. In addition, the facility for MRI should be appropriately selected to allow for prompt intervention if necessary.
The Zenith AAA Endovascular Graft may affect the image quality (image artifact) depending on the pulse sequence that is used for MR imaging.