Next Generation, Radically Smaller Aortic Aneurysm Endograft and Delivery System From Cook Medical Submitted For Clinical Trial Approval
November 6, 2008
Bloomington, Ind., November 6, 2008 – Cook Medical, the world leader in endovascular repair of aortic disease, has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration for its new Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft. With IDE approval, Cook will initiate a clinical trial to evaluate the safety and efficacy of the radically smaller endograft delivery system, that will permit treatment of AAA patients with smaller vascular anatomies who otherwise may not have been candidates for minimally invasive endovascular treatment.
The Zenith Low Profile AAA Endograft System employs a 16 French delivery sheath, significantly thinner in diameter than the current system used by Cook and other companies, which is 20 to 22 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 to enable the guidewire and delivery sheath to enter the artery with far less trauma and blood loss. With the Zenith Low Profile, physicians can endovascularly serve an additional subset of AAA patients previously 'ineligible' for endovascular treatment due to anatomical restrictions.
“Seven months ago, we announced the first implant of the Zenith Low Profile device. We're very pleased that an IDE requesting clinical use of the device in the United States has been submitted and is currently undergoing FDA review,” said Phil Nowell, global leader of Cook Medical's Aortic Intervention strategic business unit. “This milestone marks yet another major step forward in Cook's ongoing efforts to bring the most sophisticated technology to a greater subset of patients suffering from aortic disease.”
The Zenith Low Profile continues Cook's ongoing commitment to developing technologies that help physicians perform minimally invasive diagnostic and therapeutic procedures with the least possible trauma to the patient. Currently, endograft delivery systems for abdominal and thoracic aortic aneurysms are inserted through the femoral arteries, as their diameters are typically too large to be inserted percutaneously. The Zenith Low Profile design enables physicians to navigate the device through narrow, tightly curved arteries to reach the aneurysm with potentially less risk of trauma to the patient’s blood vessels. It will also make treatment available for those patients who have a vascular anatomy too small to accept the current generation of larger delivery systems, particularly female patients and individuals of smaller stature.
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.