Healthcare Industry News: Ventana
News Release - November 2, 2010
Endologix Announces First Clinical Implant of Ventana Stent GraftNew Endovascular Platform has Potential to Expand the EVAR Market
IRVINE, Calif., Nov. 2, 2010 (Healthcare Sales & Marketing Network) -- Endologix, Inc. (Nasdaq:ELGX ), developer of minimally invasive treatments for aortic disorders, announced today the first clinical implant of the Company's Ventana™ fenestrated stent graft at Auckland City Hospital in Auckland, New Zealand. The procedure was performed by Andrew Holden, MD (Associate Professor and Director of Interventional Radiology) and Andrew, Hill, MD (Associate Professor of Surgery). Attending the procedure as a medical advisor was Daniel G. Clair, MD (Chairman, Cleveland Clinic Department of Vascular Surgery, Cleveland, OH). This was the first case in the Pilot Study of this novel endovascular platform and the patient's juxtarenal aneurysm was successfully excluded while maintaining full perfusion of the renal arteries and visceral vessels.
The Ventana fenestrated stent graft is a new aortic extension designed to be used with the anatomically-fixed Powerlink® bifurcated stent graft. It was developed to provide an off-the-shelf treatment option for the endovascular repair of juxtarenal and certain pararenal aortic aneurysms (JAA/PAA), which represent complex aneurysms that extend near to or involve the renal arteries. There are currently no FDA-approved, commercially available endovascular options for these patients.
It is estimated that 20% of diagnosed abdominal aortic aneurysms are not treatable with currently approved endovascular devices because they have extremely short aortic necks and/or involve the renal arteries. Although not commercially available in the United States, endovascular repair of these difficult anatomies has been achieved with custom made fenestrated devices that take several weeks lead time to design and manufacture.
Dr. Holden commented, "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. 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."
Dr. Clair added, "Unfortunately, many patients with JAA and PAA do not have much time to wait and need to be treated immediately to avoid aneurysm rupture. 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."
Beginning with the first clinical cases being performed with Ventana at Auckland City Hospital, Endologix will continue enrolling patients in international clinical studies in 2011. The results will be used to support international regulatory approvals to market the device, with international commercialization expected to commence in 2012. Endologix also expects to submit an Investigational Device Exemption (IDE) to the United States Food and Drug Administration ("FDA") to support initiation of a prospective, multicenter, clinical trial for the treatment of JAA/PAA utilizing the Ventana fenestrated stent graft in 2011.
John McDermott, Endologix President and Chief Executive Officer said, "The successful first implant of the Ventana fenestrated stent graft is a major milestone for the Company. Through our close collaboration with physicians, we have completed extensive development and testing of the new device and look forward to making this technology available to physicians and their patients in the near future. We believe that Ventana will expand the EVAR market as it represents the first off-the-shelf solution to treat patients who otherwise have limited or no endovascular options. In combination with our recently announced acquisition of Nellix, Endologix will be able to treat the widest range of AAA anatomies, which further strengthens our position as an innovation leader in the marketplace."
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company's flagship product is the Powerlink® System, which is an endovascular stent graft for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 75%, making it a leading cause of death in the U.S. Additional information can be found on Endologix's Web site at www.endologix.com.
Except for historical information contained herein, this news release contains forward-looking statements, including the planned expansion of Endologix's product portfolio, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including the approval and success of sales efforts for new products, product research and development efforts, and other economic, business, competitive and regulatory factors. The Company undertakes no obligation to update its forward looking statements. Please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2009, and the Company's other filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.
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