Device typeHeart valve clip: An implantable device intended for the reconstruction of an insufficient mitral and/or tricuspid heart valve and reduction of valve regurgitation through the fixed approximation of the valve leaflets. It is typically implanted using a percutaneous clip delivery system (CDS) guided by echocardiographic and fluoroscopic imaging. It is typically made of implant grade metal alloys with a polyester fabric cover. Disposable devices associated with implantation (e.g., CDS and accessories) may be included.
FDA categoryMitral Valve Repair Devices
Device ID00690103221664
Catalog number30000ACEMRA
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional