Cook Reports Preliminary Reimbursement for Endovascular AAA Repair in Japan
January 22, 2007
Bloomington, Ind., January 22, 2007 – Furthering its leadership position in the Japanese market, Cook Medical today announced preliminary hospital reimbursement for endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) has been granted in Japan. The company’s Zenith AAA stent graft, the world’s most frequently used EVAR device, is the only device approved for sale in Japan for this type of procedure. Cook expects full reimbursement in Japan in March 2007, which will precipitate a complete rollout of the Zenith stent graft system across the Asian country.
“Cook was first to the market with this life-saving medical device technology in August 2006 and in just four months we have hit another major milestone with this news of preliminary reimbursement,” said Barry Thomas, global leader of Cook’s Endovascular Therapies division. “Our rapid progress in Japan is the direct result of a collaborative effort involving Cook’s worldwide endovascular team, and our Japanese distributor, Medico’s Hirata Co. Ltd.”
Medico’s Hirata’s approval was granted on July 11, 2006 under Japanese Pharmaceutical Affairs Law, Article 14-1, Clause 1, Paragraph 1 applied to article 23 of said law under approval number 21800BZY10175000. Cook’s Zenith endograft will be reexamined three years after the approval date. A requirement of approval includes providing detailed clinical training to Japanese physicians to ensure their safe and effective use of the device. The device, the most widely used AAA endograft in the world, has a nine-year history of successful use in Europe and a seven-year history in the US.
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 H&L-B One-Shot™ Introducer System that allows simple, accurate deployment and positioning of the graft. According to 3rd party market research data, the Zenith AAA Endovascular Graft is the largest-selling device of its kind in the world.
About Cook Medical
The world’s largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOK® Medical (www.cookmedical.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for drug-eluting and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials and contract manufacturing of biopharmaceuticals, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and women’s health, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.