Healthcare Industry News: abdominal aortic aneurysm
News Release - July 29, 2010
Endologix Receives FDA Approval for PowerFit Aortic ExtensionsIRVINE, Calif., July 29 (Healthcare Sales & Marketing Network) -- Endologix, Inc. (Nasdaq:ELGX ), developer of minimally invasive treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its new PowerFit™ Aortic Extensions. The PowerFit extensions are designed to provide physicians with enhanced visibility under fluoroscopy to facilitate precise device placement during completion of the Anatomical Fixation endovascular repair of abdominal aortic aneurysm (AAA). In addition, PowerFit's independent stent design and 24 circumferential contact points were shown in anatomical simulation studies to aid in proximal conformability and sealing.
John McDermott, President and Chief Executive Officer said, "The new PowerFit line of aortic extensions enhances our expanding product offering, with the added benefits of improved visibility during placement and design features that facilitate anatomical conformability and sealing. In conjunction with anatomical fixation using the IntuiTrak Endovascular System, and our recently launched new sizes, Endologix offers a comprehensive product offering for the treatment of AAA. We look forward to the full U.S. market launch of PowerFit and our new sizes during the fourth quarter."
PowerFit is designed for use with Endologix's existing products, including Powerlink® main body bifurcated stent grafts and the IntuiTrak® Endovascular System. It will be available in a range of sizes indicated to treat aortic necks ranging from 18 to 32 millimeters in diameter. In addition, the PowerFit product line will be available with longer stent lengths of up to 120 millimeters, to expand the treatment options for physicians and their patients. PowerFit will initially be launched through a limited market release during the third quarter of 2010, followed by a full U.S. market release during the fourth quarter of 2010.
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, 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 success of sales efforts for the Powerlink System and related 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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