Cook Incorporated Receives FDA Approval For Clinical Investigation Of Zenith TX2 Thoracic Aneurysm Graft
December 9, 2003
Bloomington, Ind. – Cook Incorporated may begin a clinical investigation of its endovascular graft for thoracic aortic aneurysms (TAA) in human patients under an investigational device exemption granted by the U.S. Food and Drug Administration. The company received conditional approval to begin a clinical trial of its Zenith® TX2™ Thoracic TAA Endovascular Graft involving 140 subjects at 20 U.S. medical institutions, and patient enrollment will begin soon, company officials report. A larger study may be permitted following FDA approval of modifications to the company’s proposed clinical protocol.
“Coronary stents have been among the most dramatically successful medical device innovations in the last decade, and we believe the opportunity for vascular grafts is at least as exciting,” explained Kem Hawkins, president and chief executive officer of Cook Incorporated. “Cook’s leadership in vascular stents and other technologies to treat vascular disease in the peripheral arteries further enhances our position as a pioneer in innovative medical solutions for patients worldwide. We look forward to the successful completion of our clinical trial and the U.S. launch of this companion product line to our market-leading Zenith AAA Endovascular Graft system.”
The Zenith TX2 Thoracic TAA Endovascular Graft, which already is approved for commercial distribution in Australia and Asia, incorporates clinically proven technologies to treat life-threatening thoracic aortic aneurysms. Thoracic aortic aneurysms occur when a section of the aorta, the body’s main circulatory vessel, weakens and bulges outward like a balloon. Should the aneurysm rupture, the patient would be at high risk for death due to internal bleeding.
Patients diagnosed with TAA traditionally have had to undergo a highly invasive open surgical procedure during which a vascular surgeon clamps off the aorta and sews a surgical graft in place to prevent the aneurysm from rupturing. Such open surgical procedures carry significant health risks for many older patients, who may also suffer from other significant medical conditions such as diabetes or hypertension.
Clinical experience outside the U.S. suggests that Cook’s Zenith TX2 Thoracic TAA Endovascular Graft system permits treatment of these 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 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. Patients treated with minimally invasive endovascular devices such as the Zenith aortic graft typically experience less trauma and enjoy a much shorter recovery period compared to patients undergoing open surgical procedures.
With international headquarters in Bloomington, Ind., privately held COOK® (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.