IRVINE, Calif. (April 8, 2008)
Endologix, Inc. (Nasdaq: ELGX), the developer and manufacturer of the Powerlink® System for the minimally invasive treatment of abdominal aortic aneurysms (AAA), today announced that the first two procedures with the Company’s Powerlink System have been performed in Japan following receipt of Shonin approval.
Both procedures were performed at Osaka University Hospital on April 4, 2008 by Dr. Toru Kuratani, Assistant Professor of Cardiovascular Surgery, an associate of Dr. Yoshiki Sawa, Professor of Cardiovascular Surgery, at the same institution. In attendance as the clinical trainer was Dr. Satoshi Kawaguchi, Assistant Professor of Vascular Surgery, an associate at Tokyo Medical University Hospital of Dr. Hiroshi Shigematsu, Professor of Vascular Surgery. Dr. Kawaguchi was a primary investigator of the Powerlink System in the Japanese clinical trial. In addition to Tokyo Medical University Hospital, the Japanese clinical trial was conducted at five other hospitals: Tohoku University Hospital, Fukushima Medical University Hospital, Tokai University Hospital, Yamaguchi University Hospital and Kurume University Hospital.
The first case was a 73 year-old patient with an AAA complicated by a narrowing of the left common iliac artery, and the second case featured an anatomy that included a calcified stenosis of the aorta just above the aneurysm. Implantation of the Powerlink device took one hour in the first case and 40 minutes in the second case.
“Both implants were completed successfully. I believe the unibody design of the Powerlink simplifies the implant procedure by eliminating much of the guidewire manipulation required to implant multi-piece systems. I also believe the design will reduce the risk of late problems associated with stent graft migration. I have been very impressed by the published long-term data of the Powerlink, especially the continued decrease of Type II endoleaks over time. In my view, the Powerlink design of a long main body and ability of the graft to balloon off of the endoskeleton has been instrumental in this finding,” said Dr. Kawaguchi.
Commenting on today’s announcement, Paul McCormick, President and Chief Executive Officer of Endologix, said, “We are proud to have our Powerlink System being used in Japan, where we estimate that 14,000 open repair surgeries for AAA are performed annually. In the U.S. the Powerlink was the fifth stent graft to obtain marketing approval, five years behind the very first approved device. In Japan the Powerlink System is one of only three approved commercial stent grafts and our approval came only 14 months following the first device approval. It is more of a level playing field as we launch in Japan and we believe that bodes well for product adoption. We believe that uptake in Japan will build as more physicians gain experience with our product. The launch of the Powerlink in Japan expands our international presence with ongoing marketing efforts in Europe and recent approvals in key Latin American markets.”
Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the Powerlink System was received on February 5, 2008, and reimbursement was publicly announced by the Medical Insurance manager of the MHLW on March 31, 2008.
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, including our belief that endovascular repair will achieve clinical acceptance in Japan and that the Powerlink System will be adopted by vascular surgeons in the Japanese market, 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.
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