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.
Galderma secures EU MDR certification for Sculptra, expanding use to multiple body areas
Clinical Laserthermia Systems applies for CE marking of ClearPoint Prism neuro laser system
Bonesupport shifts CERAMENT V review to FDA's De Novo pathway
Neola Medical secures US patent for disposable lung monitoring probes
Remington Medical's VascuChek 2.0 Cordless Bluetooth-Enabled Doppler Secures FDA Clearance
Aetna to launch generative AI-powered conversational experience
Maxx Orthopedics Receives FDA 510(k) Clearance for Its Libertas® Bipolar Hip System
Ascletis Pharma announces ASC36 and ASC35 co-formulation for clinical development
Adocia files patent for long-acting peptide platform AdoXLong and updates on BioChaperone studies
Nurami Medical completes Phase 1 milestones in EIC-backed grant for Artifix