- 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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