Cordis eyes vascular closure market with US trial for ExoSeal device:
This article was originally published in Clinica
Executive Summary
As part of efforts to enter the vascular closure device market, Cordis has begun a pivotal US trial of its ExoSeal product for closing punctures in patients undergoing catheterisation procedures. The trial, called ECLIPSE, will assess the safety and efficacy of ExoSeal versus manual compression, as a means of closing vascular access sites in patients who have undergone diagnostic or interventional procedures. It is a non-blinded, randomised study that will encompass 400 patients from 18 medical centres. ExoSeal features a synthetic bioabsorbable polymer and is being studied to determine whether it can enable expedited the cessation of bleeding, faster patient ambulation and reduced bed-stay. Nearly eight million patients undergo cardiac catheterisation procedures annually, said Cordis, a Johnson & Johnson company.