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Cook receives IDE approval to start clinical trial of AAA endovascular graft
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Cook
: 27 November, 2008 (New Product) |
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Cook Medical has received Investigational Device Exemption (IDE) conditional approval from the US Food and Drug Administration (FDA) to begin a clinical trial for its Zenith Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft. |
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The trial, which will include 24 sites, is designed to evaluate the safety and effectiveness of the smaller endograft delivery system in 120 patients, enabling the endovascular treatment of AAA patients with smaller vascular access vessels who otherwise may not have been candidates for minimally invasive endovascular treatment.
“We are thrilled to receive the green light from the FDA to move forward with a clinical trial for the Zenith Low Profile AAA Endovascular Graft,” said Phil Nowell, global leader of Cook Medical's Aortic Intervention strategic business unit. “We look forward to initiating this trial that brings greater precision and ease of delivery to endovascular aortic repair (EVAR). This major advance in EVAR technology furthers our commitment to developing innovative devices that bring minimally invasive treatment options to all patients suffering from aortic disease.”
Employing a 16 French delivery sheath, the Zenith Low Profile AAA Endograft System is significantly narrower in diameter than the current system used by Cook and other companies, which is 20 to 24 French.
The advanced delivery system enables physicians to reduce the need for a surgical cut down to access the femoral artery for device insertion, thereby allowing the use of the less-invasive percutaneous entry technique in many cases. With this approach, a needle is inserted into the blood vessel through the skin, allowing the guidewire and delivery sheath to enter the artery with much less blood loss and trauma. With the Zenith Low Profile, physicians have the opportunity to endovascularly serve an additional subset of patients previously 'ineligible' for endovascular treatment due to anatomical restrictions.
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