indiCations The Medtronic CoreValve and CoreValve Evolut R systems are indicated for use
in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or
failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged
by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy
(ie, Society of Thoracic Surgeons predicted risk of operative mortality score ≥8% or at a ≥15% risk
of mortality at 30 days).
ContRaindiCations The CoreValve and CoreValve Evolut R systems are contraindicated for
patients presenting with any of the following conditions: known hypersensitivity or contraindication
to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel),
or sensitivity to contrast media, which cannot be adequately premedicated; ongoing sepsis,
including active endocarditis; preexisting mechanical heart valve in aortic position.
WaRnings General Implantation of the CoreValve and CoreValve Evolut R systems should be
performed only by physicians who have received Medtronic CoreValve training. This procedure
should only be performed where emergency aortic valve surgery can be performed promptly.
Mechanical failure of the delivery catheter system and/or accessories may result in patient
complications. Transcatheter Aortic Valve (Bioprosthesis) Accelerated deterioration of the
bioprosthesis may occur in patients presenting with an altered calcium metabolism.
PRECautions General The safety and effectiveness of the CoreValve and CoreValve Evolut R
systems have not been evaluated in the pediatric population. The safety and effectiveness of
the bioprosthesis for aortic valve replacement have not been evaluated in the following patient
populations: patients who do not meet the criteria for symptomatic sever native aortic stenosis
as defined: (1) symptomatic severe high gradient aortic stenosis – aortic valve area ≤1.0cm2 or
aortic valve area index ≤0.6 cm2/m2, a mean aortic valve gradient ≥40 mmHg; or a peak aortic-jet
velocity ≥4.0 m/s, (2) symptomatic severe low-flow/low-gradient aortic stenosis – aortic valve
area ≤1.0cm2 or aortic valve area index ≤0.6 cm2/m2, a mean aortic valve gradient <40 mmHg; and a
peak aortic-jet velocity <4.0 m/s ; who are at moderate or low surgical risk (predicted perioperative
mortality risk of <15%); with untreated, clinically significant coronary artery disease requiring
revascularization; with a preexisting prosthetic heart valve with a rigid support structure in
either the mitral or pulmonic position if either the preexisting prosthetic heart valve could affect
the implantation or function of the bioprosthesis or the implantation of the bioprosthesis could
affect the function of the preexisting prosthetic heart valve; with cardiogenic shock manifested
by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. The safety
and effectiveness of a CoreValve or CoreValve Evolut R bioprosthesis implanted within a failed
preexisting transcatheter bioprosthesis has not been demonstrated. Implanting a CoreValve or
CoreValve Evolut R bioprosthesis in a degenerated surgical bioprosthesis [transcatheter aortic
valve in surgical aortic valve (TAV in SAV)] should be avoided in the following conditions. The
degenerated surgical bioprosthesis presents with a: significant concomitant perivalvular leak
(between the prosthesis and the native annulus), is not securely fixed in the native annulus, or is
not structurally intact (eg, wireform frame fracture); partially detached leaflet that in the aortic
position may obstruct a coronary ostium; stent frame with a manufacturer’s labeled inner diameter
<17 mm. The safety and effectiveness of the bioprosthesis for aortic valve replacement have not
been evaluated in patient populations presenting with the following: blood dyscrasias as defined:
leukopenia (WBC <1000 cells/mm3), thrombocytopenia (platelet count <50,000 cells/mm 3), history
of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital bicuspid or unicuspid
valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic
regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid
regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic
evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus si