A Medical Device Daily

Cordis (Miami Lakes, Florida) reported launch of the ECLIPSE Trial for its ExoSeal vascular closure device. ECLIPSE is a multicenter, non-blinded, randomized study designed to measure the safety/efficacy of the ExoSeal vs. manual compression to close vascular access sites in patients having undergone diagnostic or interventional procedures.

ExoSeal, featuring a synthetic bioabsorbable polymer, is being studied to determine whether it can expedite hemostasis (the cessation of bleeding), faster patient ambulation and reduced bed-stay after catheterization.

It represents Cordis' entry into the vascular closure market. Nearly eight million patients undergo cardiac catheterization procedures annually.

While a variety of methods stop the bleeding after catheter removal, they can cause significant discomfort and require several hours of bed-rest.

"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, MD, chief technology officer.

Cordis is a business of Johnson & Johnson (New Brunswick, New Jersey).