Healthcare Industry News:  Cook 

Devices Interventional FDA

 News Release - September 24, 2007

Cook Medical Receives FDA Approval to Begin U.S. Phase I Clinical Trial for Cook Zenith(R) Dissection Endovascular System

Company's Unique New Endovascular System to be Studied at Three Investigational Sites in the U.S. for the Treatment of Dissections of the Descending Thoracic Aorta

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Cook Medical has received approval from the U.S. Food and Drug Administration (FDA) to begin its three-center US Phase I clinical trial designed to evaluate the Cook Zenith® Dissection Endovascular System for the treatment of Type B thoracic aortic dissections. The groundbreaking trial is being conducted at Thomas Jefferson University in Philadelphia, Penn.; the University of Florida in Gainesville, Fla.; and Massachusetts General Hospital in Boston, Mass.

The Phase I clinical trial will include 15 subjects across the three U.S. sites. The principal investigators are Dr. Joseph Lombardi of Thomas Jefferson University, Dr. Anthony Lee of University of Florida and Dr. Richard Cambria of Massachusetts General Hospital. The trial's primary objective is to evaluate the Cook Zenith Dissection Endovascular System, comprised of the Cook Zenith Dissection Stent, used in conjunction with the Cook Zenith TX2® Endovascular Graft, in adult subjects. Initial results of the trial are expected to be available in Q1 2008.

"We are excited that the FDA has given us the green light to start the Phase I clinical trial for the Cook Zenith Dissection Endovascular System," said Barry Thomas, vice president of Cook Aortic Intervention. "This is an important milestone in the development of treatments for thoracic aortic dissections, a condition that affects tens of thousands of lives annually. We anxiously await the trial results and look forward to continuing to best serve patients with the most minimally-invasive alternatives available."

The Cook Zenith Dissection Endovascular System is intended for use in the endovascular treatment of descending thoracic aortic dissection in patients with anatomies amenable to endovascular repair. The device's unique Z-stent exerts a minimal radial force that allows gradual apposition of the dissection septum and re-expansion of the true lumen.

Endovascular aortic repair (EVAR) eliminates the need for highly invasive open surgery. Rather than opening the chest cavity and clamping off the aorta to surgically implant a graft to treat the damaged section of the aorta, physicians insert a catheter loaded with a self-expanding, fabric covered stent-graft through a surgical opening in the femoral artery. The catheter is guided through the patient's blood vessels under fluoroscopy until the device is positioned across the weakened section of the aorta. The stent-graft expands upon deployment from the catheter to form a continuous tube through the aorta that carries the blood and reduces pressure on the damaged vessel, restoring normal blood flow. The uncovered Zenith Dissection Stent may be used to expand the true lumen in the distal thoracic aorta where preservation of the side branch artery blood flow is critical.

The Cook Zenith Dissection Endovascular System is an investigational device not available in the United States. The Cook Zenith TX2 Endovascular Graft is approved in Europe, Australia and New Zealand for the treatment of thoracic aortic aneurysms. Cook Medical has submitted its application to the FDA for approval to sell the Cook Zenith TX2 in the United States.

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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