A Medical Device Daily

In a move that Cook (Bloomington, Indiana) said further expands its global reach, the company's Zenith Endograft, which it said is the world's top-selling device for endovascular repair of abdominal aortic aneurysms (AAA), has been approved for sale in Japan.

The decision makes Cook's Zenith endovascular graft system the first and only device available for endovascular repair of AAA in that country, one of the world's largest medical markets.

"Cook's success in being first to market in Japan with this life-saving medical device technology is the direct result of a collaborative effort involving [our] worldwide endovascular team and our Japanese distributor, Medico's Hirata Inc. ," said Barry Thomas, global leader of Cook's Endovascular Therapies division.

Cook's Shonin filing was approved in mid-July. The Zenith endograft is approved as a new medical device and that status will be reexamined three years after the approval date. Cook also will provide detailed clinical training to Japanese physicians to ensure safe and effective use of the device. The approval was granted on the basis of the Zenith U.S. pivotal trial results, as well as on the basis of a limited confirmation trial that was performed in Japan.

The device, the largest-selling AAA endograft in the world, has a nine-year history of successful use in Europe and a seven-year history in the U.S.

"As a physician who has treated numerous AAA patients, I welcome the introduction of Cook's Zenith endograft technology in Japan," said Kimihiko Kichikawa, professor of radiology at Nara Medical University. "Minimally invasive treatment of aortic aneurysms can greatly reduce patient suffering and recovery times compared to open surgical repair, important qualities considering that AAAs most commonly occur in older patients who may not be able to withstand the rigors of surgery."

Professor Takao Ohki, MD, of Jikei University School of Medicine 's department of vascular surgery, said, "There are many patients in Japan waiting for an endograft to become available. The OR time for this procedure can be as little as 80 minutes when performed under local anesthesia. An aortic abdominal aneurysm treated with Cook's Zenith endograft can have a patient discharged home on the second day."

He added, "We are very excited to see this technology become available in Japan and look forward to successfully treating many patients in Japan, as has been the experience elsewhere in the world."

Prior to the development of endovascular treatment, patients diagnosed with a large, swelling abdominal aortic aneurysm that could rupture faced extensive open surgery requiring days of recovery time in the hospital and weeks of post-procedural recovery time before they could resume normal activities.

During endovascular repair, the physician makes two small incisions in the groin to insert catheters that are guided under fluoroscopy to the site of the aneurysm. Once in place, the catheters deploy a self-expanding endograft constructed of polyester surgical graft material supported by stainless steel Z-stent bodies.

According to third-party market research data, the Zenith AAA Endovascular Graft is the largest-selling device of its kind in the world.

Viking adds three distributors

Viking Systems (San Diego), a manufacturer of high-performance laparoscopic vision systems for use in minimally invasive surgical (MIS) procedures, has expanded its international distribution network by adding three new strategic partners in South Korea, the Netherlands and Ukraine.

The company entered the Asian market by signing an exclusive agreement with LeoMedics Co. Ltd. (Seoul, South Korea). Hospital evaluations of Viking's technology will begin this month, with Korean FDA clearance projected prior to year-end.

"Minimally invasive surgery is growing rapidly in Korea and our exclusive agreement to market Viking Systems' innovative and economical EndoSite 3Di Digital Vision System provides us with the opportunity to better serve our hospitals and their patients," said Yong-Jin Cho, CEO of LeoMedics. "In addition to the restoration of depth perception, our surgeons are attracted by the comfort of the head-mounted displays versus the strain of viewing a distant monitor especially during longer procedures."

Viking Systems also has expanded its European penetration by entering into exclusive agreements with Arsis Medical in the Netherlands and MedComplex-MC Ltd. in Ukraine. These countries join with exclusive agreements already established in Italy, Germany, Austria, Switzerland, Sweden and Russia, to position Viking Systems to capitalize on the growth of MIS throughout Europe.

"Surgeons and hospitals around the world are rapidly adopting the benefits of our 3-D technology to enhance their performance in complex minimally invasive procedures," said Stephen Heniges, vice president, corporate accounts and international business at Viking Systems. "The visual aspect of depth perception, which has been a critical missing component from traditional minimally invasive surgery, translates to better patient outcomes and reduced operating times. Our international customers also appreciate the shortened learning curve our EndoSite 3Di device provides for mastering new and complex procedures."

Rockeby gets avian flu test order

Australian diagnostic company Rockeby biomed has secured a contract to supply its Avian Flu Rapid test to the Indonesian island of Bali after recent reports of outbreaks of avian flu.

Indonesian farming authorities have ordered 2,000 of Rockeby's tests after hundreds of dead chickens on Bali were tested positive for the H5N1 strain of bird flu. Around 300 birds died of the virus in Bali's westernmost Jembrana district.

Rockeby biomed chief executive Dr. Sze-Wee Tan said the company's avian flu tests were recognised by Indonesian authorities as being the most effective in detecting the outbreak of avian flu among poultry populations.

Rockeby is negotiating with a number of health authorities around the world where outbreaks have occur-red, including Italy, Turkey and Romania.

OGT outlicenses Southern array patents

Oxford Gene Technology (OGT; Oxford, UK) reported the second in a series of Japanese licensing agreements giving Yamatake Corp. access to OGT's Southern array patents, the fundamental patents covering the manufacture and commercialization of oligonucleotide microarrays.

This microarray license will enable Yamatake to manufacture gemkey microarrays using in situ synthesis and market them, via its distributor Sigma-Aldrich Japan.