Quicker Patient Recovery After Catheterization

A vascular closure device that features a synthetic bioabsorbable polymer is being studied to determine whether it can enable expedited hemostasis, patient ambulation, and reduced bed-stay after a catheterization procedure.

The Eclipse trial is a multicenter, non-blinded, randomized study designed to measure the safety and efficacy of the ExoSeal vascular closure device compared to manual compression in closing vascular access sites in patients who have undergone diagnostic or interventional procedures. The trial will encompass 400 patients from 18 medical centers across the United States. The ExoSeal vascular closure device is being developed by Cordis (Miami Lakes, FL, USA), the cardiac and vascular technologies division of Johnson & Johnson (New Brunswick, NJ, USA)

"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' efforts to accelerate the development of new devices to improve the treatment of vascular diseases,” said Campbell Rogers, M.D., chief technology officer (CTO) at Cordis. "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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