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First U.S. Registry Reports Initial Success of Zenith® Renu™ System
Device May Be Best For Treating Aortic Endograft Fixation Failure -To Be Presented At 2006 Vascular Annual Meeting, June 1 – 4, Philadelphia, Pa.
PHILADELPHIA (June 03, 2006) —
The Zenith® Renu™ AAA Ancillary Graft System appears to be a versatile and potentially durable solution when used for aortic endograft fixation failure, according to initial post-market surveillance registry results presented at the 60th Annual Meeting of the Society for Vascular Surgery. This is the first known registry of physician experience with the device reported in the United States.
Early versions of the Zenith® Renu™ system have been used successfully in Europe and Australia since 1998. The currently available device was first implanted in the United States in September 2005. An FDA mandated registry to collect experience with the device in the U.S. is currently underway and case registration is ongoing. Samuel R. Money, MD, head of the section of vascular surgery at the Ochsner Clinic Foundation in New Orleans, is the lead physician overseeing the Zenith® Renu™ system registry. Analysis of the multi-institutional registry data collected thus far has revealed good results in terms of successful treatment of proximal endograft fixation failure using the minimally invasive Zenith® Renu™ device.
“At last follow-up, very few cases of persistent proximal fixation failure were reported,” noted Krishna Mannava, MD, lead author and vascular surgical fellow at the Ochsner Clinic Foundation in New Orleans. “Our preliminary evaluation of data suggests that patients with favorable aortic neck anatomy may be less susceptible to persistent proximal failure after treatment with the Renu™ system than patients with a challenging neck anatomy such as a conical neck shape, a short aortic seal length, or severe angulation.”
He added that endovascular aneurysm repair (EVAR) has increased the number of patients treated for abdominal aortic aneurysms; however, complications persist with significant frequency. “One of the most serious long-term complications is device migration caused when a stent ‘slips’ downward within the aorta, which can result in an endoleak (leakage of blood back into the aneurysm sac), and ultimately can lead to a devastating aneurysm rupture,” said Dr. Mannava. “One theory as to why this complication occurs is thought to be weakness in the attachment of the proximal portion of the graft to the inside of the aortic wall.”
Open surgical conversion has been used traditionally for treatment of this complication, however this procedure carries a high morbidity and mortality rate, added Dr. Mannava. In contrast, the Zenith® Renu™ system was developed specifically as a minimally invasive, endovasular treatment option for endograft attachment failure. Dr. Money believes that using the new device can help save numerous patients from potentially dangerous open surge
About the Society for Vascular Surgery
The Society for Vascular Surgery (SVS) is a not-for-profit medical society that seeks to advance excellence and innovation in vascular health through education, advocacy, research and public awareness. SVS is the national advocate for 2,400 vascular surgeons dedicated to the prevention and cure of vascular disease.
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© 2008 VascularWeb. All rights reserved. Use of the VascularWeb site constitutes acceptance of all of the policies, rules and regulations for the site.