Cordis Corporation Starts Pivotal Trial for ExoSeal™ Vascular Closure Device
Cordis Corporation, a worldwide leader in developing and manufacturing interventional vascular technology, announced today the start of the pivotal trial for the ExoSeal™ Vascular Closure Device. The ECLIPSE Trial is a multicenter, non-blinded, randomized study designed to measure the safety and efficacy of the ExoSeal™ Vascular Closure Device versus manual compression to close vascular access sites in patients having undergone diagnostic or interventional procedures. The trial will encompass 400 patients from 18 medical centers across the United States.
On February 13, Principal Investigator Chiu Wong, M.D., associate professor of Medicine, New York-Presbyterian Hospital/Weill Cornell Medical Center, and a Cordis Corporation consultant, treated the first patient in the trial. Prior to the start of the ECLIPSE Trial, the ExoSeal™ Vascular Closure Device had been used in 150 patients participating in a first-in-human study for the device.
“The results from the first-in-man study were very encouraging, and this trial will help us determine whether those results can be maintained in a larger number of patients,” said Dr. Wong. “As an interventional cardiologist, I welcome the opportunity to investigate a device that could help patients recover faster from a catheterization procedure.”
The ExoSeal™ Vascular Closure Device features a synthetic bioabsorbable polymer and is being studied to determine whether it can enable expedited hemostasis (the cessation of bleeding), faster patient ambulation (ability to walk) and reduced bed-stay after a catheterization procedure. It also represents Cordis Corporation’s entry into the vascular closure device market. Nearly eight million patients undergo cardiac catheterization procedures annually.
“The swift progress of the ExoSeal™ Vascular Closure Device from the proof-of-concept stage to a pivotal trial in only seven months marks a major milestone in Cordis Corporation’s efforts to accelerate the development of new devices to improve the treatment of vascular diseases,” said Campbell Rogers, M.D., chief technology officer, Cordis Corporation. “The ECLIPSE Trial will help us evaluate whether the ExoSeal™ Vascular Closure Device could make a significant and positive difference in patients’ comfort as well as recovery time following a catheterization procedure.”
Catheterization procedures involve the temporary insertion of a catheter into an artery, usually the femoral artery, through a vascular puncture. While a variety of methods, such as manual compression, sandbags and mechanical clamps have been used to close the puncture site and stop the bleeding after the catheter is removed, many of these methods cause significant discomfort and require several hours of bed-rest.
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