DevicePMAs@therightstef:P100009_S028 JSONTXT

{"project":"PMA_MER","denotations":[{"id":"T1","span":{"begin":0,"end":8},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25425"},{"id":"T2","span":{"begin":35,"end":43},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61560"},{"id":"T3","span":{"begin":44,"end":50},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T4","span":{"begin":78,"end":86},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61560"},{"id":"T5","span":{"begin":87,"end":93},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25700"},{"id":"T6","span":{"begin":112,"end":122},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41184"},{"id":"T7","span":{"begin":126,"end":133},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C74521"},{"id":"T8","span":{"begin":134,"end":143},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25667"},{"id":"T9","span":{"begin":151,"end":164},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C50726"},{"id":"T10","span":{"begin":233,"end":240},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25261"},{"id":"T11","span":{"begin":279,"end":288},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15368"},{"id":"T12","span":{"begin":327,"end":333},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C70667"},{"id":"T13","span":{"begin":334,"end":343},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25667"},{"id":"T14","span":{"begin":367,"end":380},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C50726"},{"id":"T15","span":{"begin":392,"end":397},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48309"},{"id":"T16","span":{"begin":402,"end":405},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C65039"},{"id":"T17","span":{"begin":426,"end":442},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16525"},{"id":"T18","span":{"begin":472,"end":476},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25229"},{"id":"T19","span":{"begin":472,"end":506},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C4710"},{"id":"T20","span":{"begin":477,"end":488},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C38055"},{"id":"T21","span":{"begin":498,"end":506},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25514"},{"id":"T22","span":{"begin":539,"end":543},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25229"},{"id":"T23","span":{"begin":544,"end":555},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C38055"},{"id":"T24","span":{"begin":556,"end":559},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25496"},{"id":"T25","span":{"begin":569,"end":578},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25483"},{"id":"T26","span":{"begin":618,"end":626},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25676"},{"id":"T27","span":{"begin":687,"end":704},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C94845"},{"id":"T28","span":{"begin":705,"end":710},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12727"},{"id":"T29","span":{"begin":711,"end":715},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C86041"},{"id":"T30","span":{"begin":735,"end":745},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25214"},{"id":"T31","span":{"begin":750,"end":759},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15368"},{"id":"T32","span":{"begin":763,"end":768},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12727"},{"id":"T33","span":{"begin":763,"end":776},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C50577"},{"id":"T34","span":{"begin":769,"end":776},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25745"},{"id":"T35","span":{"begin":781,"end":793},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12753"}],"text":"Approval for the MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System for expanding the indication to include secondary mitral regurgitation. The devices, when used with maximally tolerated guideline-directed medical therapy (GDMT), are indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR \u003e= Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) \u003e= 20% and \u003c= 50%, and a left ventricular end systolic dimension (LVESD) \u003c= 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease."}