Endologix Announces FDA Approval Of IntuiTrak, An Innovative New Delivery System For The Powerlink AAA Device

Main Category: Medical Devices / Diagnostics
Also Included In: Cardiovascular / Cardiology;  Regulatory Affairs / Drug Approvals
Article Date: 22 Oct 2008 - 8:00 PDT

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Endologix, Inc. (NASDAQ:ELGX) today announced U.S. Food and Drug Administration (FDA) approval of the IntuiTrak™ Delivery System. This innovative new system will be used for the minimally invasive delivery and deployment of the Powerlink stent graft, which is indicated for the endovascular repair of abdominal aortic aneurysms (AAA). The company plans to conduct a limited market release over the next several months and expects a full commercial launch in the U.S. in the second quarter 2009.

IntuiTrak has a novel design and deployment mechanism that simplifies delivery of the unibody bifurcated Powerlink device. The low-profile delivery system features enhanced flexibility, advanced hemostasis control and a hydrophilic coating to facilitate smooth delivery, particularly in patients with limited or difficult vascular access. Additionally, the delivery catheter has an integrated sheath to facilitate the introduction of ancillary devices during the endovascular AAA procedure. This feature avoids the need for exchanges, thereby having the potential to reduce procedure time, blood loss and minimize vessel trauma.

"The procedural advantages of the IntuiTrak Delivery System, combined with the exceptional long-term clinical results of the Powerlink device, provide physicians with a compelling technology to treat their AAA patients," said John McDermott, Endologix President and CEO. "We are excited to begin working with physicians on the training and roll-out of IntuiTrak and expect a full market release in the second quarter of 2009."

About Endologix

Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. Endologix's Powerlink System is an endoluminal stent graft for treating 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 specifically including the expected market launch and physician acceptance of the Endologix IntuiTrak Delivery System, 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. 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, 2007, 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.

Source
John McDermott
http://www.endologix.com