WHAT'S NEW?

< previous article | Table of Contents | next article >

Approved

[Editor's Note: This new column will feature updates on new and approved devices and products, as well as corporate clinical trials of special interest to the vascular community.]

Launch of Emboshield NAV6 Embolic Protection System

Abbott announced the launch of the sixth-generation Emboshield NAV6™ Embolic Protection System for use in carotid artery stenting procedures. Carotid artery stenting provides a minimally invasive treatment alternative to conventional open carotid artery surgery for patients who are at high risk for surgery. Embolic protection systems are used during the stenting procedure to prevent particles of dislodged plaque from flowing to the brain, potentially causing an ischemic stroke. The Emboshield NAV6 is now available in the United States and Europe.

Abbott Laboratories
www.abbott.com

First Implant of 31-mm GORE EXCLUDER AAA Endoprosthesis?in the United States

On May 14, W.L. Gore \& Associates announced one of the first clinical uses of the 31-mm diameter version of the GORE EXCLUDER AAA Endoprosthesis since its approval in March 2009 by the U.S Food and Drug Administration. Dr.Wei Zhou of Stanford (Calif.) University Medical Center, performed the procedure. The device was used to treat a patient with abdominal aortic aneurysm (AAA), which is the swelling or bulging of the abdominal aorta. The GORE EXCLUDER AAA Endoprosthesis is a 31-mm device providing an endovascular option to treat AAAs in patients with aortic inner neck diameters up to 27-29 mm. The device is an endovascular graft and stent combination that isolates the aneurysm from systemic blood flow.

W.L. Gore & Associates
www.goremedical.com

Clinical Trials

Clinical Trial of Zenith
Low Profile AAA Endovascular Graft Begins

Cook Medical reported on June 11 that it initiated enrollment in a U.S. clinical trial of its Zenith Low Profile AAA Endovascular Graft (Zenith AAA LP) and the first placement of the device. The LP is a reinvention of Cook Medical's Zenith Flex AAA endograft system in which the diameter of the delivery system has been reduced to 16 French, eliminating the need for a top cap to ensure precise delivery of the device to the target location within the patient's aorta. If proven safe and effective, the new system could make EVAR possible for AAA sufferers, particular female and Asian patients, who tend to have narrower, more tortuous vessels that current AAA endografts may have difficulty navigating safely. Dr. Mark Farber of the division of vascular surgery and program director of the vascular surgery fellowship at the University of North Carolina Hospitals in Chapel Hill, performed the initial procedure at the University. The clinical trial in the United States will evaluate the safety and effectiveness of the system in 120 patients at 24 trial sites.

Cook Medical
www.cookmedical.com

Clinical Trial of EPIC
Self-Expanding Nitinol Stent System for Iliac Artery Disease

Boston Scientific Corporation announced the beginning of patient enrollment in the ORION clinical trial, which is designed to evaluate the company's EPIC Self-Expanding Nitinol Stent System for the treatment of iliac artery disease. The stent is designed to sustain vessel patency, while providing enhanced visibility during placement. The Outcome of the Rosuvastatin Treatment on Carotid Artery Atheroma: an MRI Observation (ORION) trial incorporates stent diameter ranges from 6 to 12 mm as well as lengths up to 120 mm. This trial will enroll a total of 123 patients at 25 sites across the United States and will examine the rates of device- and/or procedure-related major adverse events at 9 months. Major adverse events for this trial are currently defined as death within 30 days, myocardial infarction (MI, or heart attack) occurring during related hospitalization, target vessel revascularization through 9 months, and amputation of the treated limb through 9 months.

Boston Scientific Corporation
www.bostonscientific.com