| JenaValve Technology, Inc. |
Trilogy Transcatheter Heart Valve System
|
23, 25, 27 |
32, 34, 36 |
66–90 |
Nitinol |
Porcine pericardium |
– |
Trilogy Delivery System |
Femoral |
Single action |
20 (OD) |
126 |
Indicated for the treatment of symptomatic, severe native tricuspid aortic valve regurgitation (not due to acute endocarditis, rheumatic heart disease, or acute aortic dissection) in patients who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for surgical aortic valve replacement (ie, predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator) |
Sizing provided for all sizes of the Trilogy Valve and Delivery System; the Annular Perimeter Range is listed for all valve sizes in the “Valve Annulus Size Range” field |