Heart pump linked to 49 deaths, according to the FDA. Warns
The agency blamed the device's maker for being late informed of the growing complications, citing growing reports of how use of the device punctured the walls of the heart.
A failing heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration's decision to issue an alert about the problem. risks puncturing a wall of the heart.
Tiny Impella pumps, the width of a candy cane, are threaded into blood vessels to take over the labor of the heart in patients who undergo complex procedures or who suffer from life-threatening illnesses.
The F.D.A. said the device's maker, Abiomed, should have informed the agency more than two years ago, when the company first posted an update on its website regarding the risk of perforation. Such notice, the F.D.A. added, would have led to a much broader warning from the official agency to hospitals and doctors.
The alert is the latest of concerns raised in recent years about deadly side effects of heart disease. devices, especially those that take on the role of the heart in blood circulation. This is the FDA's third major project. action for an Impella device in one year.
A series of studies suggest that Impella cardiac devices increase the risk of death in patients with unstable medical conditions. Meanwhile, the device's manufacturer spent millions of dollars promoting the device and providing consulting fees to cardiologists and subsidies to hospitals.
Since Abiomed's first notice regarding Impella complications in October 2021, the F.D.A. received 21 additional reports of cardiac wall tears linked to patient deaths, according to Audra Harrison, an agency spokeswoman.
We are having trouble retrieving the article content.
Please enable JavaScript in your browser settings.
Thank you for your patience while we verify access. If you are in Reader mode, please exit and sign in to your Times account, or subscribe to the entire Times.
Thank you for your patience while we let's check access.
Already subscribed?
The agency blamed the device's maker for being late informed of the growing complications, citing growing reports of how use of the device punctured the walls of the heart.
A failing heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration's decision to issue an alert about the problem. risks puncturing a wall of the heart.
Tiny Impella pumps, the width of a candy cane, are threaded into blood vessels to take over the labor of the heart in patients who undergo complex procedures or who suffer from life-threatening illnesses.
The F.D.A. said the device's maker, Abiomed, should have informed the agency more than two years ago, when the company first posted an update on its website regarding the risk of perforation. Such notice, the F.D.A. added, would have led to a much broader warning from the official agency to hospitals and doctors.
The alert is the latest of concerns raised in recent years about deadly side effects of heart disease. devices, especially those that take on the role of the heart in blood circulation. This is the FDA's third major project. action for an Impella device in one year.
A series of studies suggest that Impella cardiac devices increase the risk of death in patients with unstable medical conditions. Meanwhile, the device's manufacturer spent millions of dollars promoting the device and providing consulting fees to cardiologists and subsidies to hospitals.
Since Abiomed's first notice regarding Impella complications in October 2021, the F.D.A. received 21 additional reports of cardiac wall tears linked to patient deaths, according to Audra Harrison, an agency spokeswoman.
We are having trouble retrieving the article content.
Please enable JavaScript in your browser settings.
Thank you for your patience while we verify access. If you are in Reader mode, please exit and sign in to your Times account, or subscribe to the entire Times.
Thank you for your patience while we let's check access.
Already subscribed?
What's Your Reaction?
