Cook Incorporated Begins U.S. Clinical Trial Of Zenith TX2 THORACIC Aortic Aneurysm Endograft.

Business Editors/Health/Medical Writers

BLOOMINGTON, Ind.--(BUSINESS WIRE)--April 12, 2004

A team of physicians at Thomas Jefferson University Hospital in Philadelphia, PA has completed the first U.S. placement of the Zenith(R) TX2(TM) THORACIC TAA Endovascular Graft under the device's pivotal U.S. clinical trial sponsored by Cook Incorporated. The procedure, performed by a surgical team headed by Joseph Lombardi, M.D., chief of Vascular Surgery, Methodist Hospital Division of Thomas Jefferson University Hospital with Michael Denton, M.D., Chief of Vascular Surgery at Epworth Medical Centre, Victoria, Australia in attendance, took place Tuesday, March 30.

According to the study's national principal investigator, Jon Matsumura. M.D., Associate Professor of Surgery, Northwestern University Feinberg School of Medicine, the clinical trial of the Zenith TX2 THORACIC TAA Endovascular Graft will include 220 patients at up to 35 U.S. medical institutions. "The enrollment of the first patient in this trial is an important achievement," Dr. Matsumura stated. "The Zenith TX2 clinical trial is comparing the outcomes of patients with thoracic aortic aneurysms who are treated with standard operative repair and the newer endovascular approach. This research may demonstrate that there are significant benefits with the minimally invasive approach."

"It is a precise system with a very satisfying delivery," added Joseph Lombardi, M.D., Assistant Professor of Surgery, Jefferson Medical College of Thomas Jefferson University, Philadelphia, after performing the procedure. "Despite having to use an iliac conduit for access, the procedure was very straightforward and the patient was virtually pain-free."

The Zenith TX2 THORACIC TAA Endovascular Graft, which already is approved for commercial distribution in Canada, Australia and Asia, incorporates clinically proven technologies to treat life-threatening thoracic aortic aneurysms (TAA) without the need for traumatic open surgical repair. Thoracic aortic aneurysms, which are diagnosed in more than 20,000 U.S. patients annually, occur when a section of the aorta, the body's main circulatory vessel, weakens and bulges outward like a balloon in the section of the artery that runs through the chest. Should the aneurysm grow to the point where it ruptures, the patient would be at high risk for rapid death due to internal bleeding.

Patients diagnosed with TAA traditionally have had to undergo a highly invasive open surgical procedure where a surgeon opens the chest cavity, clamps off the aorta and sews a surgical graft in place to prevent the aneurysm from rupturing. Such open surgical procedures carry high health risks for many older patients, who may also suffer from other significant medical conditions such as diabetes or hypertension.

Clinical experience with this device outside the U.S. suggests that Cook's Zenith TX2 THORACIC TAA Endovascular Graft system permits treatment of many thoracic aneurysms without the need for major open surgery. TAA patients treated with the Zenith TX2 system require just one incision in the groin to allow the insertion of the graft's advanced delivery system into the femoral artery. Once the catheter is guided into position through the patient's arteries under fluoroscopy, a two-piece, fabric-covered, self-expanding stent-graft is secured inside the weakened section of the thoracic aorta to relieve pressure on the aneurysm, greatly reducing the risk of rupture.

Note: The Zenith TX2 THORACIC TAA Endovascular Graft system is an investigational device not yet available for sale in the United States.

"Cook's technology for treating aortic aneurysms has earned the Zenith stent-graft family of devices a reputation for safety and clinical performance unmatched in the industry, and we're thrilled to have begun U.S. clinical trials with the newest generation of Zenith grafts to treat thoracic aneurysms," explained Kem Hawkins, president and chief executive officer of Cook Incorporated. "In the coming months, our company will unveil the most innovative and exciting line of new products ever developed for treating aortic aneurysms. Using our newest Zenith technologies, physicians can bring the benefits of minimally invasive, endovascular treatment to thousands of aneurysm patients who would otherwise have had to forego treatment. We look forward to the successful completion of our clinical trial and the U.S. launch of this companion product line to our highly respected Zenith AAA Endovascular Graft system."

With international headquarters in Bloomington, Ind., privately held COOK(R) (www.cookgroup.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for stents and stent-grafts, catheters, wire guides, introducer needles and sheaths, embolization coils, tissue-engineered medical biomaterials, vena cava filters, implanted cardiac lead extraction equipment and other minimally invasive medical devices.