Will the Unibody design reduce the risk of late problems associated with stent graft migration? Does the long-term data of the Powerlink show a continued decrease of Type II endoleaks over time? Is the Powerlink design with a long main body contributing to the ability of the graft to balloon off of the endoskeleton?
IIP> Read on here… http://www.businesswire.com
Endologix, Inc…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…
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…
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