Abbott (NYSE: ABT), a United States-based health care company, announced yesterday that it has received approval from the United States Food and Drug Administration (FDA) for a next-generation version of its leading MitraClip heart valve repair device used to repair a leaky mitral valve without open-heart surgery.
The transcatheter clip-based therapy has been used to treat more than 65,000 patients worldwide over the last ten years.
The new MitraClip system is claimed to provide cardiologists with advanced steering, navigation, and positioning capabilities for the clip, making it easier to use in difficult anatomies. The enhanced system is designed to allow for more precise placement during deployment, resulting in more predictable procedures, and additionally offers a second clip size with longer arms that expands the reach of the clip-based device. The additional clip size is designed to help doctors treat patients who have more complex anatomies when repairing the mitral valve.
Abbott has already received the CE Mark for the next-generation device, allowing its sale in the European Union and other countries that recognise this regulatory designation.
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