Endologix, Inc. (Nasdaq:ELGX) today announced that the first patient has been treated in Endologix ongoing suprarenal clinical trial with the Powerlink 34 mm System, a modification of Endologix U.S. Food and Drug Administration (FDA)-approved Powerlink(R) System. The Powerlink 34 mm System is designed to treat abdominal aortic aneurysm (AAA) patients with large diameter aortic necks and, if approved, would be the only endoluminal stent graft (ELG) for use in aneurysms with neck diameters up to 32 millimeters (mm). The procedure was performed at Newark, Del.-based Christiana Hospital by Drs. Mark Garcia and Sonya Tuerff. "With the Powerlink 34 mm System, we were able to treat this patient who otherwise had limited treatment alternatives," said Dr. Garcia. "Due to the size of his proximal aorta, this patient was not a suitable candidate for effective treatment with any of the commercially available ELGs, and based on his condition and age, highly invasive conventional surgery would not have been a good option," added Dr. Tuerff. "I was delighted by the ease of use of the Powerlink 34 mm System. The patient recovered rapidly from this surgery and was discharged home two days following the procedure." Paul McCormick, Endologix president and chief executive officer, said, "The Powerlink 34 mm System has the ability to expand the universe of AAA patients suitable for minimally invasive ELGs as approximately 5-10% of those evaluated are excluded due to a large aortic neck diameter." Endologix has also received FDA approval to initiate a seven center, 60-patient protocol utilizing a large diameter infrarenal cuff with its approved Powerlink bifurcated device. This study, along with the ongoing suprarenal clinical trial, allows Endologix to study alternative implant strategies to treat AAA in those patients eligible for minimally invasive procedure. About Endologix Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. Endologix's Powerlink System is an endoluminal stent graft (ELG) 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 the thirteenth leading cause of death in the U.S. In October 2004, Endologix received approval to market the Powerlink 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, including risks related to the clinical trials and regulatory approvals, and payor acceptance of new medical device products, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix, all as more fully described in the risk factors and other matters set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2004, and the Company's other filings with the Securities and Exchange Commission.
Endologix (NASDAQ:ELGX)
Historical Stock Chart
From May 2024 to Jun 2024 Click Here for more Endologix Charts.
Endologix (NASDAQ:ELGX)
Historical Stock Chart
From Jun 2023 to Jun 2024 Click Here for more Endologix Charts.