FDA Takes Note Of Higher Risk For Women With Stroke-Preventing Implants

The FDA informed health care providers of the potential for differences in procedural outcomes between women and men undergoing implant of a left atrial appendage occlusion (LAAO) device.
Currently, two companies market transcatheter LAAO devices in the U.S. - Boston Scientific Corporation BSX, with its Watchman and upgraded Watchman FLX implants, and Abbott Laboratories ABT with its Amplatzer Amulet.
LAAO device is a small implant that seals off a spare pocket in the heart wall to help cut down a person's risk of stroke.
The agency is evaluating a registry study of nearly 50,000 patients, published in JAMA Cardiology, that linked LAAO devices to a significantly higher risk of in-hospital adverse events in women compared to men.
During open surgery, the appendage can also be sealed with sutures, staples, or other devices for another heart condition.
However, only the first-generation, minimally invasive Watchman device was covered by the registry study.
Cases of major bleeding occurred in 1.7% of women vs. 0.8% in men, while rates of pericardial effusion, or the dangerous build-up of fluid around the heart, were logged at 1.2% vs. 0.5%.
Overall, 6.3% of women had at least one type of adverse event compared to 3.9% of men, while procedure-associated deaths happened in 0.3% of women vs. 0.1% of men.
The agency is working with manufacturers to assess other data sources before deciding on the next steps.
The FDA said that the root causes have not yet been determined and that it believes the implants' benefits continue to outweigh the risks.
Related content: Benzinga's Full FDA Calendar.
Price Action: BSX stock closed up 0.50% at $43.89, and ABT stock closed up 0.61% at $119.46 on Wednesday.

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