Cook Medical Enrolls First U.S. Patient In STABLE Aortic Dissection Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices
Article Date: 13 Feb 2008 - 2:00 PDT

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Cook Medical announced enrollment of the first U.S. patient in the STABLE global clinical trial designed to evaluate the Cook Zenith® Dissection Endovascular System for the treatment of Type B thoracic aortic dissections. This is the first device designed specifically to treat aortic dissections, the condition that took the life of actor John Ritter. The technologically advanced device is the first-of-its-kind worldwide and was designed to treat the unique morphology of this disease, a major cause of mortality worldwide.

The patient was treated by Joseph Lombardi, M.D., assistant professor at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania. Dr. Lombardi is the global principal investigator of the STABLE trial. Performing the surgery with Dr. Lombardi was Robert A. Larson, M.D., assistant professor at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania. Dr. Larson is the site PI for the STABLE trial at Thomas Jefferson University.

The first U.S. patient found suitable for inclusion in the STABLE dissection clinical trial was a 79-year-old male diagnosed with a Type B dissection of his thoracic aorta. The patient was treated with the Cook Zenith Dissection Endovascular System, which is comprised of the new Cook Zenith Dissection Stent, used in conjunction with the Cook Zenith TX2® Endovascular Graft. A Zenith TX2 Proximal Component stent graft sealed over the entry tear in the thoracic aortic arch, and two bare Zenith Dissection Endovascular Stents were placed end to end, extending down the aorta to the level of the aortic bifurcation (where the aorta branches in two down the legs).

"The STABLE trial is an important milestone in the development of novel, minimally invasive treatments for thoracic aortic dissections," said Dr. Lombardi, director of the aortic center at Thomas Jefferson University Hospital. "Within all areas of vascular medicine, our goal is to best serve our patients with the safest and most effective treatment options available. We are confident that the STABLE trial will significantly help treat a condition that ultimately affects tens of thousands of lives annually."

"We are proud to announce the enrollment of a U.S. patient in the STABLE trial as it marks our continued effort to treat thoracic aortic dissections worldwide," said Phil Nowell, global director of Cook's Aortic Intervention strategic business unit. "We anticipate that the STABLE trial will confirm the success of the Cook Zenith Dissection Endovascular System and highlight the positive outcomes for our patients. We are delighted to have Dr. Lombardi as a global principal investigator in the study as he plays an integral role in Cook's mission to offer patients the least invasive treatment options, ultimately leading to a successful and speedy recovery."

The Cook Zenith Dissection Endovascular System is intended for use in the endovascular treatment of descending thoracic aortic dissection in patients with anatomies appropriate for endovascular repair. The technologically-advanced device has unique Z-stents that exert pressure allowing gradual apposition of the dissection septum and re-expansion of the true lumen, while keeping important arteries exposed that supply the spinal cord with blood.

Endovascular aortic repair (EVAR) eliminates the need for highly-invasive, traumatic open surgery for thoracic aneurysms and dissections. Rather than opening the chest cavity and clamping off the aorta to surgically implant a graft to treat the damaged section of the thoracic 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 dissected section of the aorta. The stent-graft then expands upon deployment from the catheter to reopen the original path through the aorta and reduces blood flow into the false pathway in the damaged vessel wall, thereby restoring normal aortic blood flow. The uncovered Zenith Dissection Stent is 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 and dissections. Cook 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 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.

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