Healthcare Industry News: cell therapy
News Release - July 10, 2007
International Clinical Trial Shows Positive Results Using Cook Medical's Zenith TX2(R) Thoracic Aortic Aneurysm Endovascular Graft Compared to Open Surgical Repair
12-Month Results on Cook Zenith TX2 with Thoracic Endovascular Aortic Repair Presented at the Annual Meeting of the Society for Vascular SurgeryBLOOMINGTON, Ind.--(HSMN NewsFeed)--A non-randomized, controlled study, led by Jon S. Matsumura, M.D., generated positive results on the Cook Zenith TX2 Thoracic Aortic Aneurysm (TAA) Endovascular Graft for thoracic endovascular aortic repair (TEVAR), Cook Medical reported today. The trial results indicated that the TEVAR procedure, using the Cook Zenith TX2, is a promising alternative to open surgical repair for the treatment of TAAs. The results were presented June 9 at the 61st annual meeting of the Society for Vascular Surgery in Baltimore, Maryland.
Dr. Matsumura, along with trial investigators Richard P. Cambria, M.D., Michael D. Dake, M.D., Roy K. Greenberg, M.D., Randy D. Moore, M.D. and Lars G. Svensson, M.D., presented 12-month data on 230 patients in the multi-center, international trial. The study, which included primary endpoints for 30-day survival and 30-day rupture-free survival, comparing the minimally-invasive TEVAR procedure using Cook's TX2 device to a control group that underwent open surgical repair for their thoracic aneurysms.
Dr. Matsumura reported that the 30-day survival rate for patients in the test group who received the Cook Zenith TX2 TAA Endovascular Graft was similar to the open surgery group (98.1 versus 94.3 percent). The Zenith patients experienced no ruptures or conversions in the first year. Cumulative morbidity scores were significantly lower at 30 days for the TEVAR patient group compared to the open surgery patient group (1.3 +/- 3.0 vs. 2.9 +/- 3.6). More specifically, TEVAR patients had fewer cardiovascular, pulmonary and vascular adverse events compared to patients treated by open surgery.
"The results from this international trial clearly demonstrate potential benefits to patients may be associated with TEVAR with the Cook Zenith TX2 TAA Endovascular Graft as compared to open surgery," said Dr. Matsumura, vascular surgeon at Northwestern Memorial Hospital and associate professor at Northwestern University Feinberg School of Medicine. "The data indicate that the Cook Zenith TX2 may serve in the future as a minimally invasive alternative to open surgery for patients with descending TAAs."
TAAs occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon, forming an aneurysm that can rupture and cause death if left untreated. The Cook Zenith TX2, a tube of surgical graft material reinforced with self-expanding stainless steel Z-stents that is sized to the length and diameter of the aorta where the aneurysm is occurring, is used to seal off the aneurysm and redirect blood flow to reduce pressure on the aneurysm sac. The device utilizes unique barbs that anchor the stent-graft to the aortic wall to reduce the risk of migration.
The Zenith TX2 device is deployed from a catheter inserted through a small incision in the patient's femoral artery, eliminating the need for invasive open surgery to open the chest, clamp off and remove the diseased section of the aorta, and replace it with a surgical graft. Post-operative and post-discharge recovery times are typically shorter with TEVAR which may help patients return to their normal lifestyle routines far faster than for those who undergo open surgery.
"TEVAR is revolutionizing the way life-threatening TAAs are treated in thousands of patients worldwide," said Barry Thomas, vice president of Cook Aortic Intervention. "This positive, 12-month clinical data on the Cook Zenith TX2's performance in TEVAR demonstrates Cook's ongoing commitment to developing and delivering advanced medical designs that best suit the patient. We are thrilled that our graft can help an additional subset of patients who may not have otherwise been treatable."
The Cook Zenith TX2 TAA Endovascular Graft is currently available as a limited access device in Europe, Australia and New Zealand. For more information, visit http://www.cookmedical.com/ai/home.do.
About Cook Medical
Cook Medical was the first company 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 for 2006 from Medical Device and Diagnostic Industry magazine. For more information, visit www.cookmedical.com.
Source: Cook Medical
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