Immediate leadership position reinforced by strong regional demand for minimally invasive treatment of abdominal aortic aneurysms
In a move that further expands Cook's global reach, the company's Zenith Endograft, 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 Japan, one of the world's largest and most important 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 Cook's worldwide endovascular team and our Japanese distributor, Medico's Hirata ," said Barry Thomas, global leader of Cook's Endovascular Therapies division.
"We wish to thank the Japanese government for placing their trust in our device and the dedicated medical professionals behind it".
Cook's Shonin filing was approved July 11, 2006 under Japanese regulation 14-1, with approval number 21800BZY10175000.
Cook's Zenith endograft is approved as a new medical device and that status will be reexamined three years after the approval date.
Cook will also provide detailed clinical training to Japanese physicians to ensure their safe and effective use of the device.
This Shonin was granted on the basis of the Zenith US pivotal trial results, as well as on the basis of the 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 USA.
"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, 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, at Jikei University School of Medicine, 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.
"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.
The major benefits of the Zenith design for endovascular AAA repair include suprarenal fixation with anchoring barbs to ensure maximal stability and graft-to-vessel sealing, woven polyester graft material that is lightweight, strong and shrink-resistant, and the HandL-B One-Shot Introducer System that allows simple, accurate deployment and positioning of the graft.
According to third party market research data, the Zenith AAA Endovascular Graft is the largest-selling device of its kind in the world.
