Endologix Provides Japanese Approval Update for Powerlink System
IRVINE, Calif. -- Endologix, Inc. (Nasdaq:ELGX) today announced progress with the process to obtain Shonin approval to market the Powerlink(R) System in Japan. The Pharmaceutical and Medical Devices Agency (PMDA) of the Japanese Ministry of Health, Labour and Welfare recently conducted its Expert Panel Meeting. As part of that meeting, the PMDA made requests that Endologix intends to fulfill with readily available information.
"Our plan is to work over the next several weeks with our Japanese distributor Cosmotec Co. Ltd. to provide responses to the PMDA in order for them to conclude their review of our Shonin application," stated Paul McCormick, president and chief executive officer of Endologix. "We are encouraged with this productive dialogue involving the Japanese regulatory authorities, and with progress that is consistent with our plans and preparations to bring our minimally invasive treatment of abdominal aortic aneurysm disease to this key market," he added.
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. Additional information can be found on Endologix's Web site at www.endologix.com.
"Our plan is to work over the next several weeks with our Japanese distributor Cosmotec Co. Ltd. to provide responses to the PMDA in order for them to conclude their review of our Shonin application," stated Paul McCormick, president and chief executive officer of Endologix. "We are encouraged with this productive dialogue involving the Japanese regulatory authorities, and with progress that is consistent with our plans and preparations to bring our minimally invasive treatment of abdominal aortic aneurysm disease to this key market," he added.
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. Additional information can be found on Endologix's Web site at www.endologix.com.
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