Cook Medical Applauds Study from New England Journal of Medicine Reporting High Success Rates of Endovascular Aortic Repair
February 1, 2008
Bloomington, Ind., Feb. 1, 2008 – Cook Medical today applauded a new study that appeared in this week’s issue of the New England Journal of Medicine. The matched cohort observational study compared the survival and complication rates of abdominal aortic aneurysm (AAA) Medicare patients treated with endovascular aneurysm repair (EVAR), as opposed to the more traditional, open surgical method. The four-year, 23,000-patient study, conducted by vascular surgeons at Beth Israel Deaconess Medical Center and Harvard Medical School, found that the short-term rates of death and complication were significantly lower with EVAR: 1.2 percent compared to 4.8 percent for patients who underwent open surgery.
Cook Medical generated similar results in a recent two-year clinical study evaluating its Zenith AAA Endovascular Graft, an EVAR device used to treat AAAs, in 430 patients located at 15 health centers throughout the United States. Data resulting from Cook’s clinical study indicated a 98.9 percent rate of survival at 30 days for standard and high medical risk AAA patients following EVAR and 97.5 percent for standard risk patients who underwent open surgery. Freedom from AAA-related mortality was high for EVAR 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 generated from the New England Journal of Medicine study and the results from our clinical study further reinforce that EVAR is the favorable choice for patients in need of AAA repair,” said Barry Thomas, vice president of Cook’s Aortic Intervention strategic business unit. “With our strong focus on and commitment to patient safety, we hope that this week’s study will encourage other vascular surgeons to consider the benefits of EVAR over traditional methods when treating those patients with appropriate anatomies.”
AAA occurs when a section of the aortic wall, the body’s main blood vessel, weakens and creates a dangerous bulge that could rupture, an often-fatal occurrence. Endovascular aneurysm repair was first introduced to the United States in 1999. A less-invasive alternative to open surgery, EVAR is performed by making two small incisions in the groin and threading two catheters through the patient’s arteries. Once in place in the weakened section of the aorta, the catheters release a tubular device comprised of large z-shaped metal stents sewn to surgical graft material that expands to channel blood through the aorta and reduce the pressure on the aneurysmal sac, lessening the risk of rupture. The recovery time for EVAR is considerably shorter than that of open surgery, decreasing hospital stays down to two to three days. EVAR patients normally return to normal activities within weeks, compared to months with open surgery.
Ruptured abdominal aortic aneurysms are currently the 10th leading cause of death in the U.S. in men over age 55, with fewer than 20 percent of people surviving a rupture. However, early detection through painless ultrasound screening and minimally invasive treatment of abdominal aortic aneurysm have historically shown a significant improvement in the survival rate for patients of all ages.
With 40 percent of the world market share, Cook Medical’s Zenith AAA stent-graft today stands as the leader in the endovascular aneurysm repair global market. For 2007, Cook’s Aortic Intervention business unit increased its global sales by 37 percent. The company expects this growth pattern to continue in 2008 with the introduction of several new minimally invasive EVAR products.
About Cook Medical
Cook Medical was one of the first companies to introduce interventional devices in the United States. Today, the company participates in all global markets, integrating device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes. Cook won the prestigious Medical Device Manufacturer of the Year from Medical Device and Diagnostic Industry magazine. For more information, visit www.cookmedical.com.