Healthcare Industry News: Cook
News Release - August 7, 2007
Cook Medical Submits Final PMA Modules to FDA for Approval of the Cook Zenith TX2(R) Thoracic Aortic Aneurysm Endovascular GraftFinal PMA Submission Includes Clinical Trial Data Proving Safety and Effectiveness of Cook Zenith TX2 with Thoracic Endovascular Aortic Repair
BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Medical has submitted the final module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Cook Zenith TX2® Thoracic Aortic Aneurysm (TAA) Endovascular Graft. Cook's PMA application includes safety and effectiveness data on approximately 230 patients who have been treated with the Cook Zenith TX2 in clinical trials at 42 sites across North America and Europe.
"Our comprehensive submission reflects the depth of the Cook Zenith TX2 clinical trial program and supports the critical safety and effectiveness criteria required to attain FDA approval," said Barry Thomas, vice president of Cook Aortic Intervention. "We look forward to working with the FDA on the PMA review and bringing the Cook Zenith TX2 to physicians and patients nationwide."
The Cook Zenith TX2 PMA includes data from the STARZ-TX2 clinical trial, a multi-national trial approved to study the safety and effectiveness of the Cook Zenith TX2 for the treatment of thoracic aortic aneurysms. The Cook Zenith TX2 preliminary results were, presented June 9 at the 61st annual meeting of the Society for Vascular Surgery in Baltimore, Maryland.
"The results from this international trial demonstrate potential benefits to patients may be associated with endovascular repair with the Cook Zenith TX2." said Jon S. Matsumura, M.D., principal investigator for the STARZ-TX2 clinical trial. "The data indicate that the Cook Zenith TX2 appears to serve as a safe and effective alternative to open surgery."
TAAs occur when the section of the aorta that runs down the chest weakens and bulges outward like a balloon. The Cook Zenith TX2, a reinforced fabric tube that is sized to the length of the aorta and covered, is used to seal off the aneurysm. The Cook Zenith TX2 helps to relieve pressure on the aneurysm and reduce the risk of rupture.
The Cook Zenith TX2 TAA Endovascular Graft is currently available in Europe, Australia and New Zealand. Cook expects to launch the Cook Zenith TX2 in the United States in Q1 2008.
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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