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Editorial
. 2023 Jan 2;2(1):100561.
doi: 10.1016/j.jscai.2022.100561. eCollection 2023 Jan-Feb.

The "Product of a Village": FDA as a Partner in Evidence Generation

Megan Coylewright  1 , Emily P Zeitler  2
Affiliations
Editorial

The "Product of a Village": FDA as a Partner in Evidence Generation

Megan Coylewright et al. J Soc Cardiovasc Angiogr Interv. .
No abstract available

Keywords: Atrial fibrillation; left atrial appendage occlusion; regulatory; sex.

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References

    1. Jiang H., Zheng Q., Cheng Y.J., et al. Sex-specific long-term outcomes of Watchman left atrial appendage closure for stroke prevention in atrial fibrillation. J Soc Cardiovasc Angiogr Interv. 2023;2(1):100541.
    1. Osman M., Patel B., Munir M.B., et al. Sex-stratified analysis of the safety of percutaneous left atrial appendage occlusion. Catheter Cardiovasc Interv. 2021;97(5):885–892. - PubMed
    1. Alkhouli M., Russo A.M., Thaler D., et al. Sex differences in safety and effectiveness of LAAO: insights from the Amulet IDE trial. JACC Cardiovasc Interv. 2022;15(21):2143–2155. - PubMed
    1. Darden D., Duong T., Du C., et al. Sex differences in procedural outcomes among patients undergoing left atrial appendage occlusion: insights from the NCDR LAAO Registry. JAMA Cardiol. 2021;6(11):1275–1284. - PMC - PubMed
    1. Reddy V.Y., Sievert H., Halperin J., et al. Committee PAS and Investigators Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014;312(19):1988–1998. - PubMed

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