Patrick M McCarthy Last month, Abbott announced that that the FDA has approved a new trial—REPAIR MR—to evaluate the safety and efficacy of percutaneous edge-to-edge repair (MitraClip) for the management of patients with primary mitral regurgitation at moderate surgical risk. Currently, in both Europe and the USA, MitraClip has market approval for [...]
MitraClip XTR The FDA has approved a first-of-its-kind clinical trial that will compare the effectiveness of Abbott’s minimally invasive MitraClip device with open heart mitral valve surgical repair in people with primary mitral regurgitation who are eligible for open-heart surgery. If successful, a press release states, the trial has the potential to [...]
MitraClip XTR Abbott has received US FDA approval for fourth-generation version of its MitraClip heart valve repair device (MitraClip G4) to treat mitral regurgitation. This latest version, according to a press release, delivers an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time [...]