News | November 08, 2010

Endovascular Platform Could Help Patients With Renal Aortic Aneurysms

November 8, 2010 – A new aortic extension has been implanted in a clinical setting for the first time. The Ventana fenestrated stent graft, by Endologix, was implanted at Auckland City Hospital in Auckland, New Zealand.

The procedure was performed by Andrew Holden, M.D., associate professor and director of interventional radiology at the hospital, and Andrew Hill, M.D., associate professor of surgery. The patient's juxtarenal aneurysm was successfully excluded while maintaining full perfusion of the renal arteries and visceral vessels.

The device is designed to be used with the anatomically fixed Powerlink bifurcated stent graft. It was developed to provide a treatment option for juxtarenal and certain pararenal aortic aneurysms (JAA/PAA), which extend near to or involve the renal arteries. There are currently no FDA-approved, commercially available endovascular options for these patients.

"We are very excited to have successfully completed the first human Ventana fenestrated stent graft procedure in the world. Given our extensive experience with aortic aneurysmal disease and understanding the limitations of all commercially available endovascular devices, we believe that Ventana has the potential to address a significant unmet clinical need – a minimally invasive alternative for patients presenting with JAA or PAA,” Holden said. “We look forward to participating in the Ventana clinical program and, following the completion of regulatory processes, having this important new technology available to treat our patients who otherwise have few options."

"Unfortunately, many patients with JAA and PAA do not have much time to wait and need to be treated immediately to avoid aneurysm rupture,” said Daniel G. Clair, M.D., chairman, Cleveland Clinic Department of Vascular Surgery. Clair attended the procedure as a medical advisor. “The Ventana off-the-shelf design is unique in that it represents a potential minimally invasive solution for these difficult to treat aneurysms. The device also leverages the good clinical results of the Powerlink design and anatomical fixation. I am pleased with the progress that Endologix has made developing this device and look forward to initiating a U.S. multicenter clinical trial in 2011."

The company will continue enrolling patients in international clinical studies in 2011. It also expects to submit an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) in 2011.

For more information: www.endologix.com

Related Content

FDA Concerned About Increase in stent graft Endovascular Type III Leaks
News | Stent Grafts| October 09, 2017
October 9, 2017 — The U.S.
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Gore Announces First-in-Human Use of Gore TAG Conformable Thoracic Stent Graft
News | Stent Grafts| July 17, 2017
W. L. Gore & Associates Inc. announced the first patient implant of the Gore TAG Conformable Thoracic Stent Graft...
New Paper Highlights Success of Advanced Treatments in Complex Aortic Aneurysm Repair
News | Endovascular Aortic Repair| May 23, 2017
Significant success has been achieved in treating complex proximal aneurysms using a combination of fenestrated and...
News | Stent Grafts| April 06, 2017
Endologix Inc. announced that the first patients were treated in the Expanding Patient Applicability with Polymer...
abdominal aortic aneurysm, AAA, gender differences, women vs. men, endovascular repair, Journal of Vascular Surgery study
News | Endovascular Aortic Repair| April 05, 2017
Following repair of abdominal aortic aneurysms (AAA), women appear to have more unfavorable outcomes than men in terms...
Gore, Viabahn VBX Balloon Expandable Endoprosthesis, stent graft, iliac artery, FDA approval
Technology | Stent Grafts| January 31, 2017
W. L. Gore & Associates (Gore) announced that the Gore Viabahn VBX Balloon Expandable Endoprosthesis (VBX Stent...
Lombard Medical, Aorfix endovascular stent graft, Japanese regulatory approval, IntellFlex LP Delivery System
News | Stent Grafts| January 11, 2017
January 11, 2017 — Lombard Medical Inc.
stent grafts, fluid flow model, clotting risk, Journal of Vascular Surgery

An anterior view is shown of the geometries of each of the graft configurations: (A) fenestrated, (B) antegrade branched, (C) retrograde branched, and (D) manifold stent graft. Image courtesy of Taylor Suess, et al.

News | Stent Grafts| January 05, 2017
January 5, 2017 — Whether patients with mechanical heart valves and stents must take blood thinners depends on how ef
Videos | Artificial Intelligence| December 19, 2016
At RSNA 2016, the key buzzwords were “deep learning,” “machine learning” and “artificial intelligence.” Vendors and m
Overlay Init