Healthcare Industry News: abdominal aortic aneurysm
News Release - March 7, 2007
First Thoracic Patient Successfully Treated with Endologix's Powerlink Dissection Stent SystemIRVINE, Calif.--(HSMN NewsFeed)--Endologix, Inc. (Nasdaq:ELGX ) today announced the successful treatment of the first thoracic aortic dissection patient with the Company's PowerlinkŪ Dissection Stent System (DSS). The Powerlink DSS, a variant of the Powerlink technology without the ePTFE graft cover, is being used as an investigational device in the European Union and is not currently available in the United States.
The procedure was performed by Professor Dieter Raithel, M.D., from the Southern Clinic in Nuremberg, Germany. The first treated patient, a 41-year-old female, in May 2006 received cardiothoracic surgery for aortic valve replacement and conduit implantation to treat an aortic dissection that originated in the ascending aorta and extended into the iliac artery. On March 1, 2007, this patient was readmitted to treat a symptomatic aortic dissection distal to the surgical conduit.
"Having treated more than 400 patients over the past seven years for abdominal aortic aneurysm (AAA) with the Powerlink, I am excited to use a system based on this innovative stent technology to treat thoracic aortic dissection," stated Dr. Raithel. "The implantation of the DSS, in combination with a proximal covered stent, was performed without problems. A control CT scan on March 5 demonstrated the diameter of the false lumen created by the aortic dissection to be 15% to 20% smaller in the segment treated by the Powerlink DSS in the first four days, and the patient was able to leave the hospital on March 6."
An aortic dissection is a separation of the layers of the aortic wall with blood flowing through these layers rather than through the normal lumen of the vessel. It can lead to either an aneurysm caused by a degeneration of the aortic wall or induce a flap of tissue resulting in malperfusion or occlusion of critical vessels with ensuing multi-organ damage, limb loss or paralysis.
"We are enthusiastic about the application of our technology to treat thoracic aortic dissection," said Paul McCormick, Endologix president and chief executive officer. "The market size for thoracic aortic pathologies is poorly defined in the clinical literature and many fatal events due to this condition may go undiagnosed. However, the incidence of aortic dissection is estimated to be more than three times that of thoracic aneurysms.
"We believe that we can continue to focus on our core AAA market, while making progress in the early development of a Powerlink variant that leverages our platform technology to address a new and clinically significant market," he added.
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. Additional information can be found on Endologix's Web site at www.endologix.com.
This press release contains forward-looking statements with respect to future product development of the Powerlink System technology and the potential existence of a commercial market for this technology to treat thoracic aortic dissection pathologies, 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, all as more fully described in the risk factors and other matters set forth in Endologix Annual Report on Form 10-K for the year ended December 31, 2005, and Endologix's other filings with the Securities and Exchange Commission. Endologix undertakes no obligation to revise the forward-looking statements contained herein to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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