A medical device is coming under scrutiny after a University of Pennsylvania-led study criticized use of the Lariat device to prevent strokes with those who have heart issues.
The study found that although using the device in that capacity, despite it not being approved by the FDA for that specific purpose, is legal, it "too often leads to urgent surgery and even death," according The Inquirer.
SentreHEART, the California-based company, that makes the device, told the newspaper that, "it agreed with the study authors that more research was warranted and that it was in the process of discussing clinical trials with the FDA."
The Lariat has been being used by doctors, including ones at the University of Pennsylvania, to close off a small sac in the heart which is thought to be the source of clots. The Inquirer reported that doctors at the University of Pennsylvania no longer use the device.
