A Medical Device Daily
Endologix (Irvine, California), maker of the Powerlink System for the minimally invasive treatment of abdominal aortic aneurysms (AAA), said the first two procedures with the company's Powerlink System have been performed in Japan after it received Shonin approval.
Both procedures were performed at Osaka University Hospital April 4 by Dr. Toru Kuratani, assistant professor of cardiovascular surgery. The first case was a patient with an AAA, complicated by a narrowing of the left common iliac artery; 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, 40 minutes in the second.
The clinical trainer for the first cases was Dr. Satoshi Kawaguchi, assistant professor of vascular surgery at Tokyo Medical University Hospital and a primary investigator of the Powerlink system in the Japanese clinical trial.
"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," Kawaguchi said. "I also believe the design will reduce the risk of late problems associated with stent graft migration."
The Japanese clinical trial was conducted at Tokyo Medical University Hospital, Tohoku University Hospital, Fukushima Medical University Hospital, Tokai University Hospital, Yamaguchi University Hospital and Kurume University Hospital.
Paul McCormick, president/CEO of Endologix, said, "In the U.S. the Powerlink was the fifth stent graft to obtain marketing approval, five years behind the 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."
Saying the company estimates that 14,000 open repair surgeries for AAA are performed annually in Japan, he added: "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."
Approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the Powerlink System was received in early February, and reimbursement was announced by the Medical Insurance manager of the MHLW on March 31.
Chinese hospital orders Mobetron
IntraOp Medical (Sunnyvale, California) said it has received an order for its Mobetron radiation therapy device from PLA General Hospital (Beijing, China). It will be the second Mobetron to be installed in Beijing, following last fall's purchase of the system by the Cancer Institute & Hospital of the Chinese Academy of Medical Sciences (CAMS).
The Mobetron is a mobile radiation device that applies a direct application of intraoperative electron-beam radiation therapy (IOERT) to a tumor during cancer surgery.
PLA General Hospital bills itself as the leading center for medical and health services for Chinese government and military members. In addition to its treatment facilities, PLA operates a post-graduate medical school and has one of the most active medical research programs in China, according to IntraOp.
The company said PLA was the first hospital in China to incorporate IORT into its radiation protocols, and "has long been a proponent of IOERT."
The Mobetron enables radiation and surgical oncologists to target the exact area that requires radiation and to deliver high doses of radiation directly to the affected tissue during the cancer surgery. Previously, PLA patients had to be transported from the operating room to a shielded linear accelerator during surgery, exposing them to bacteria and possible infection.
"Since the Mobetron is a mobile, self-shielding device, the hospital can move the Mobetron between three operating rooms with ease, avoiding the high cost of outfitting radiation rooms to accommodate traditional devices," IntraOp said.
The company said Beijing "is quickly becoming a major hub in China for IOERT development and treatment."
After acquiring a Mobetron last year, the Cancer Institute & Hospital began an exchange with The Ohio State University (Columbus) and the University of North Carolina (Chapel Hill). "This program, in which PLA General Hospital will also participate, marks a long-term commitment to Chinese-American collaboration on IOERT education and research," IntraOp said.
Thermo Fisher issues Chinese-language catalog
In other China news, Thermo Fisher Scientific (Waltham, Massachusetts), a major global supplier of products for life sciences research, said it has introduced its first Chinese-language catalog targeted specifically to markets in China.
The company said the Fisher Scientific China Laboratory Supplies Guide includes an extensive portfolio of products suited to the needs of customers in research, testing and processing facilities in that country.
"Our objective is to leverage our strong Fisher Scientific brand in China to establish the leading channel footprint in that rapidly growing market," said Alan Malus, senior vice president of Thermo Fisher Scientific and head of the company's customer channels business. "[With] this new resource, our customers in China ... [will] have greater access to the most comprehensive range of laboratory products and services available. Through our combination of catalogs, e-commerce capabilities and supply-chain services, we can offer our customers anywhere in the world choice and convenience for their laboratory purchases."
Australian forces buy Powerheart AEDs
Cardiac Science (Bothell, Washington), a maker of advanced cardiac diagnosis, resuscitation, rehabilitation and informatics products, said it has won a five-year contract from the Australian Defence Force for the initial supply of 170 Powerheart G3 Pro automated external defibrillators (AEDs) and accessories.
The company said the Australian deal "adds to a string of international wins including a 300-unit delivery for public access defibrillators for train stations in the Netherlands and a 100-unit delivery to Eastern European military forces.
The company's G3 Pro AED provides what it said is the industry's first ECG color display, manual override features, multiple rescue capability and "the most advanced technology for rescue professionals' emergency treatment of sudden cardiac arrest."