Healthcare Industry News:  abdominal aortic aneurysm 

Devices Interventional

 News Release - November 20, 2008

Cook Medical Receives Conditional Approval from FDA to Begin Clinical Trial for Zenith® Low Profile AAA Endovascular Graft

New York, NY, November 20, 2008 – (HSMN NewsFeed) - Cook Medical, the world leader in endovascular repair of aortic disease, has received Investigational Device Exemption (IDE) conditional approval from the U.S. Food and Drug Administration (FDA) to begin a clinical trial for its Zenith Low Profile abdominal aortic aneurysm (AAA) Endovascular Graft. 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. The company announced the conditional IDE approval at this year's VEITHsymposium, a five-day, rapid-fire event featuring presentations from world-renowned vascular specialists.

“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. This 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.

About Cook Medical:

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates minimally invasive medical device design, biopharma, gene and cell therapy, and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Founded in 1963 and operated as a family-held private corporation, Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.

About VEITHsymposium:

Now in its fourth decade, VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The 5-day event features 350 rapid-fire presentations from world-renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new technique. VEITHsymposium is sponsored by Cleveland Clinic.


Source: Cook Medical

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