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Endologix Announces FDA Approval Of The IntuiTrak Express Delivery System

April 07, 2017

Endologix, Inc. (NASDAQ: ELGX) announced U.S. Food and Drug Administration (FDA) approval of the IntuiTrak™ Express Delivery System for the Powerlink XL® stent graft. The IntuiTrak Express incorporates novel design, delivery and deployment features and enables delivery of the Powerlink XL stent graft through the IntuiTrak 19Fr introducer sheath during the endovascular repair of abdominal aortic aneurysms (AAA) in patients with aortic necks up to 32mm in diameter.

Approval of the IntuiTrak Express provides additional treatment options to physician users and includes a 21Fr IntuiTrak stand-alone delivery system for the Powerlink XL stent grafts that incorporates its own integrated, hydrophilically coated introducer sheath with advanced hemostasis control.

The family of IntuiTrak Delivery Systems, first approved for U.S. commercialization in October 2008, represents an array of low-profile delivery systems with enhanced flexibility, advanced hemostasis control and hydrophilic coating to facilitate smooth delivery, particularly in patients with limited or difficult vascular access. The integrated introducer sheath eliminates the need for sheath exchanges in introducing ancillary devices during the endovascular AAA procedure, thereby offering the potential to reduce procedure time and blood loss, and minimize vessel trauma.

"The IntuiTrak Express delivers our large diameter 34-millimeter proximal extensions through a 19Fr Introducer Sheath, making it the lowest profile U.S.-approved AAA device for the repair of large neck AAA. We believe this unique combination of a low-profile delivery system and the exceptional clinical results demonstrated in the Powerlink XL clinical trial offers a clear competitive advantage," said John McDermott, Endologix President and CEO. "We plan to conduct a limited market release with the IntuiTrak Express over the next several months and expect a full commercial launch in the U.S. in the third quarter of 2009. This is our fourth FDA approval in the past six months, which positions Endologix for continued growth in 2009 and the years ahead."

About Endologix

Endologix, Inc. develops and manufactures innovative therapies for aortic disorders. The company's IntuiTrak System is an endovascular 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 endologix.

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 Express 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, 2008, 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.