CardioTech International, a developer and manufacturer of medical devices and materials, has received approval from the U.K. Ministry of Health to add a 4-mm graft for the clinical trial of CardioPass, its synthetic coronary bypass graft.
Until now, the trial was only approved for a 5-mm graft, according Wilmington, Mass.-based CardioTech.
“Adding a second graft size for the 10-patient clinical trial offers the surgeons an important new option and a larger potential pool of patients to be reviewed for graft implant eligibility for the trial. We now have two sites for the trial that will be able to have both CardioPass sizes for use in the trial,” said Michael F. Adams, CEO and president of CardioTech.
The company said its CardioPass is designed to be an alternative for patients, who have undergone repeat procedures or have insufficient native vessels for bypass.