COOK Applauds and Confirms Data from the Journal of Vascular Surgery Reporting High Success Rates of Endovascular Aortic Repair
March 14, 2006
Bloomington, IN – March 14, 2006 – Cook Incorporated, the largest privately held medical device manufacturer in the world, today applauded a new study that appeared in the March, 2006 issue of the Journal of Vascular Surgery. The study of medical records compared the survival rates of abdominal aortic aneurysms (AAAs) patients treated with endovascular aortic repair (EVAR), a minimally invasive endovascular procedure, as opposed to the more conventional, open surgical method. The three-year, 28,000-person study, which was conducted at the University of Pittsburgh, revealed that the risk of in-hospital death was significantly lower with EVAR: 1.9 percent compared to 5.2 percent for patients who underwent open surgery.
In the two-year follow-up of the pivotal clinical study, patients with the Zenith AAA Endovascular Graft, an EVAR device used to treat AAAs, COOK generated similar compelling results. Data resulting from COOK’s clinical study indicated a 98.9 percent rate of survival at 30 days for endovascular patients following EVAR and 97.5 percent for patients who underwent open surgery. Good freedom from AAA-related mortality was maintained for endovascular patients through two years, with 98.9 percent AAA-related survival of standard-risk patients and 93.8 percent for high-risk patients.
“Both the data posted in the Journal of Vascular Surgery and the results from our clinical studies further demonstrate that EVAR is the optimal choice for patients requiring AAA treatment,” said Barry Thomas, global leader of Cook’s endovascular therapy products division. “With our constant focus on patients, we are proud that EVAR performed with our Zenith AAA Endovascular Graft delivers an even higher survival rate for AAA patients than was seen in the University of Pittsburgh study.”
EVAR, which provides a less-invasive alternative to open surgery, is performed by making two incisions in the groin and threading two catheters through the patient’s arteries. The catheters, once in place, release a tubular device comprised of large z-shaped stents sewn to surgical graft material that expands to channel blood through the aorta and reduce the pressure on the aneurysmal sac. The use of EVAR has increased dramatically since 2000 with the procedure making up more than 40 percent of AAA repairs in 2003. The continuous success by physicians has accounted for this steady growth in adopting EVAR for AAA patients.
“As these data demonstrate convincingly, COOK has brought to the industry a reliable device that provides me and other physicians dealing with endovascular aortic aneurysm repair with consistent success in treating diseases affecting the more proximal aorta,” said Takao Ohki, M.D., chief of vascular and endovascular surgery at Montefiore Medical Center, Albert Einstein College of Medicine. “The results of this COOK U.S. clinical study and the University of Pittsburgh study are yet another reassurance that the Zenith endograft and EVAR will continue to bring positive outcomes for our patients.”
About Cook Incorporated
With international headquarters in Bloomington, Ind., COOK® (www.cookgroup.com), the world’s largest privately held medical device manufacturer, 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 stents and stent-grafts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.