Cook Medical to begin clinical trial for Zenith Dissection System.
The FDA has approved a 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 Phase I clinical trial will include 15 subjects across the three US centers. The principal investigators are Dr Joseph Lombardi, Thomas Jefferson University, Dr Anthony Lee, University of Florida and Dr Richard Cambria, Massachusetts General Hospital. The trial’s primary objective is to evaluate the Cook Zenith Dissection Endovascular System, comprized 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 the first quarter of 2008. 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 reexpansion of the true lumen. The Cook Zenith Dissection Endovascular System is an investigational device not available in the US. 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 US. “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. We anxiously await the trial results and look forward to continuing to best serve patients with the most minimally-invasive alternatives available.”