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EVAR Endograft > Next Generation > Radically Smaller Aortic Aneurysm Endograft > Delivery System > Cook Medical > Submitted For Clinical Trial Approval > cook’s clinical trial > Evaluate Zenith(R) Low Profile AAA Endovascular Graft > Endovascular aortic repair > Available to more patients > Reduce risk of vessel trauma

Has the IDE requesting clinical use of the Zenith Low Profile device in the United States been submitted? Is this a major step forward in Cook’s efforts to bring EVAR technology to a greater subset of patients suffering from aortic disease? Have migration and endoleaks failures of endografts let to moe secondary interventions?

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IIP > read on here > http://biz.yahoo.com…

…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…

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.

This was written by admin. Posted on Friday, November 7, 2008, at . Filed under Aorfix Dacron stent-graft, Surgical revision, Stent graft migration following endovascular aneurysm r, Type I endoleaks, Endovascular techniques prone to similar complications, Aneurysm rupture, GORE EXCLUDER AAA Endoprosthesis, Life Line Screening, Fixation of stent grafts, Stent graft fixation product, Stent grafts have a tendency to migrate, Endoleaks, Benefit from screening, Keep the graft in place, Paraplegia secondary to spinal cord ischaemia, Complication of stent-graft repair, Abdominal aortic aneurysms have no symptoms, Abdominal aortic aneurysm AAA repair, Endovascular abdominal aortic aneurysm repair, Endovascular Aneurysm Repair EVAR Trials, endovascular therapies, Abdominal Aortic Aneurysm, Endovascular and coronary products, Endovascular resection, Endovascular Valve, Men in England are to be offered AAA screening, Endovascular aneurysm repair EVAR, Endovascular Therapy, Endovascular repair of abdominal aortic aneurysms EVAR, Stent Stapler, Stapling may replace stitching, Watchful waiting, Treatment of aneurysms, Open aneurysm repair, Surgical aneurysm repair, Endoaneurysmorrhaphy, Elective surgical treatment of AAA, Albert Einstein, Sudden severe back or abdominal pain, Abdominal aortic aneurysm AAA, Ultrasound screening, Endovascular stent graft, Silent killer, Risk of developing AAA, Totally laparoscopic AAA replacement, Larger aneurysms can leak or rupture, Ascending aortic aneurysm, Simple $50 ultrasound scan, Free screening for AAA, Welcome to Medicare physical, Scanning and visualizing the aorta, Screen the aorta, Stent-graft technology under serious scrutiny, Subsidiary of a major stent-graft company, Need for reintervention, Endovascular stenting, Long-term graft performance, AAA stent-graft device, Warning letter, Rupture of an abdominal aortic aneurysm. Bookmark the permalink. Follow comments here with the RSS feed. Both comments and trackbacks are currently closed.