The Abbott Park, Ill.-based company suspended enrollment in the Shield II investigational device exemption study after a report of decreased impeller speed at the end of a procedure.
The HeartMate PHP system is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed on patients with severe coronary artery disease. Abbott spokesperson Jason Pacquette confirmed the trial suspension and told MassDevice that no patient was harmed by the impeller speed issue.
This is not the first time Abbott paused the Shield II trial. It also did so temporarily in 2017 due to an issue with its catheter. Abbott acquired the Thoratec line of HeartMate cardiac assist devices when it paid $25 billion for St. Jude Medical (NYSE:STJ) that year. Shield II began enrolling patients in 2015.
CORRECTION: A previous version of this article named the wrong device.