CoreValve™ Evolut™ PRO System
CoreValve™ Evolut™ PRO Transcatheter Aortic Valve
Delivery Catheter System
Loading System
Caution: Implantation of the Medtronic CoreValve™ Evolut™ PRO system should be
performed only by physicians who have received Medtronic CoreValve™ Evolut™ PRO
training.
These devices are supplied sterile for single use only. After use, dispose of the delivery
catheter system and the loading system in accordance with local regulations and hospital
procedures. Do not resterilize.
Instructions for Use
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Medtronic, Medtronic with rising man logo, and Medtronic logo are trademarks of
Medtronic. Third-party trademarks (“TM*”) belong to their respective owners. The following
list includes trademarks or registered trademarks of a Medtronic entity in the United States
and/or in other countries.
AOA™, CoreValve™, EnVeo™, Evolut™
Sterile LC: Device has been sterilized using liquid chemical
sterilants according to EN/ISO 14160.
Explanation of symbols on package labeling
Use by
Consult instructions for use at this website
Do not reuse
Do not resterilize
Size
Serial number
Catalog number
Lower limit of temperature
Quantity
Lot number
Sterilized using ethylene oxide
Nonpyrogenic
MR Conditional
Do not use if package is damaged
Manufacturer
Date of manufacture
Model
For US audiences only
Keep dry
Keep away from sunlight
Manufactured in
Maximum guidewire diameter
2
EVOLUTPRO-23-US
23 mm
17b/18 mm to 20 mm
53.4c/56.5 mm to 62.8 mm
EVOLUTPRO-26-US
26 mm
20 mm to 23 mm
62.8 mm to 72.3 mm
EVOLUTPRO-29-US
29 mm
23 mm to 26 mm
72.3 mm to 81.7 mm
1.0 Device description
The Medtronic CoreValve™ Evolut™ PRO system is a recapturable transcatheter aortic
valve replacement system, which includes the CoreValve Evolut PRO transcatheter aortic
valve (bioprosthesis)a, the delivery catheter system (catheter), and the loading system (LS).
1.1 CoreValve Evolut PRO transcatheter aortic valve (bioprosthesis)
Figure 1: 23 mm
bioprosthesis
Figure 2: 26 mm
bioprosthesis
Figure 3: 29 mm
bioprosthesis
The bioprosthesis is manufactured by suturing 3 valve leaflets and an inner skirt, made from
a single layer of porcine pericardium, onto a self-expanding, multi-level, radiopaque frame
made of Nitinol. The bioprosthesis has a porcine pericardial tissue outer skirt (wrap), which
is 1.5 cells in height and is sutured to the inflow section of the bioprosthesis. It is designed to
replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and
without concomitant surgical removal of the failed valve.
The bioprosthesis is processed with alpha-amino oleic acid (AOA™), which is a compound
derived from oleic acid, a naturally occurring long-chain fatty acid. The bioprosthesis is
available for a range of aortic annulus diameters (Table 1).
Table 1: Patient anatomical criteria
Bioprosthesis model Size
Aortic annulus
diameter
Aortic annulus perimeter
(π × aortic annulus diameter)
1.2 Delivery catheter system (catheter)
The catheter comes in different models: the EnVeo™ PRO catheter (Model ENVPRO-16US) and the EnVeo™ R catheter (Model ENVEOR-N-US).
a
The terms “bioprosthesis” and “transcatheter aortic valve” are synonymous terms and are used interchangeably
throughout the document to refer to the CoreValve Evolut PRO device.
b
Diameter for surgical aortic valve (SAV)
c
53.4 mm for surgical bioprosthetic aortic annulus
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The catheter facilitates the placement of the bioprosthesis within the annulus of the aortic
valve. The catheter assembly is flexible and compatible with a 0.035 in (0.889 mm)
guidewire. The distal (deployment) end of the system features an atraumatic, radiopaque
catheter tip and a capsule that covers and maintains the bioprosthesis in a crimped position.
The capsule includes a distal flare to enable the bioprosthesis to be partially or fully
recaptured after partial deployment. A stability layer is fixed at the handle and extends down
the outside of the catheter shaft. It provides a barrier between the retractable catheter and the
introducer sheath and vessel walls, thus enabling the catheter to retract freely. An EnVeo
inline sheath is assembled over the stability layer, which functions as a hemostatic introducer
sheath and minimizes the access site size to the capsule diameter. The catheter is compatible
with a 20 Fr (6.7 mm) introducer sheath.
The delivery catheter system consists of a catheter with an integrated handle to provide the
user with accurate and controlled deployment. The handle is on the proximal end of the
catheter and is used to load, deploy, recapture, and reposition the bioprosthesis. The handle
features a gray front grip used to stabilize the system. The deployment knob turns to deploy
the bioprosthesis precisely. Arrows on the deployment knob indicate the direction of rotation
required to deploy the bioprosthesis. If desired, the deployment knob can be turned in the
opposite direction to partially or fully recapture the bioprosthesis if the radiopaque capsule
marker band has not yet reached the distal end of the radiopaque paddle attachment. Once the
radiopaque capsule marker band reaches the distal end of the radiopaque paddle attachment,
it is at the point of no recapture. The deployment knob also features a trigger, which can be
engaged to make macro adjustments to the capsule position. A blue hand rest connects to the
deployment knob. The end of the handle features a tip-retrieval mechanism, which can be
used to withdraw the catheter tip to meet the capsule after the device has been fully deployed.
The catheter packaging contains an integrated loading bath and a removable tray with
3 rinsing bowls for loading and rinsing the bioprosthesis. The integrated loading bath features
a mirror, which aids in accurate placement of the bioprosthesis frame paddles during loading.
In addition to these features, the device packaging is swiveled and secured to facilitate the
bioprosthesis loading procedure.
Figure 4: Catheter
1. Catheter tip
2. Capsule (20 Fr [6.7 mm] outer diameter [OD])
3. Catheter shaft
4. Stability layer
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5. 16 Fr equivalent EnVeo inline sheath (20 Fr [6.7 mm] OD)
6. EnVeo inline sheath flush port
7. Stability layer flush port
8. Gray front grip
9. Deployment knob
10. Trigger
11. Blue hand rest
12. Tip-retrieval mechanism
13. Capsule flush port
14. Wire lumen flush port
1. 7.7 cm
2. 107 cm
3. 88.6 cm
4. 30 cm
Figure 5: Catheter
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Figure 6: Catheter distal tray
Figure 7: Catheter proximal tray
1. Tray connector
2. Swivel hinge
3. Clip holder
4. Mirror
5. Integrated loading bath
6. Tray tab
7. Locking clip
8. Rinsing bowls
9. Tray tab holder
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1.3 Loading system (LS)
The LS compresses the bioprosthesis into the catheter. The LS comes in different models: the
EnVeo PRO LS (Models L-ENVPRO-1623US and L-ENVPRO-16-US) and the EnVeo R LS
(Models LS-MDT2-23-US and LS-MDT2-2629-US).
Figure 8: EnVeo PRO LS
1. Catheter tip guide tube
2. Inflow cone
3. Backplate
4. Outflow cone
5. Capsule guide tube
6. Locking collar
1. Catheter tip guide tube
2. Inflow cone
3. Backplate
Figure 9: EnVeo R LS
4. Outflow cone
5. Capsule guide tube
Refer to Table 2 for system compatibility.
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L-ENVPRO-1623US
LS-MDT2-23-US
EVOLUTPRO-26-US
L-ENVPRO-16-US
LS-MDT2-2629-US
EVOLUTPRO-29-US
Table 2: System compatibility
Bioprosthesis model Compatible LS models Compatible catheter models
EVOLUTPRO-23-US
ENVPRO-16-US
ENVEOR-N-US
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2.0 Indications
The Medtronic CoreValve Evolut PRO system is indicated for relief of aortic stenosis in
patients with symptomatic heart disease due to severe native calcific aortic stenosis who are
judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter
heart valve replacement therapy.
The Medtronic CoreValve Evolut PRO system is indicated for use in patients with
symptomatic heart disease due to 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 (i.e., STS predicted risk of operative
mortality score ≥8% or at a ≥15% risk of mortality at 30 days).
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3.0 Contraindications
The CoreValve Evolut PRO system is contraindicated in patients who cannot tolerate Nitinol
(titanium or nickel), an anticoagulation/antiplatelet regimen, or who have active bacterial
endocarditis or other active infections.
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4.0 Warnings and precautions
Carefully read all warnings, precautions, and instructions for use for all components of the
system before use. Failure to read and follow all instructions or failure to observe all stated
warnings could cause serious injury or death to the patient.
4.1 Warnings
General
• Implantation of the Medtronic CoreValve Evolut PRO system should be performed only
by physicians who have received Medtronic CoreValve Evolut PRO training.
• The transcatheter aortic valve is to be used only in conjunction with the delivery catheter
system and the loading system.
• System failure could occur if an incorrect combination of devices is used. Refer to
Table 2 for system compatibility.
• This procedure should only be performed where emergency aortic valve surgery can be
performed promptly.
• Do not use any of the Medtronic CoreValve Evolut PRO system components if any of
the following has occurred:
• It has been dropped, damaged, or mishandled in any way
• The Use By date has elapsed
• Mechanical failure of the delivery catheter system and/or accessories may result in
patient complications.
Transcatheter aortic valve (bioprosthesis)
• Do not use the bioprosthesis if any of the following conditions is observed:
• There is any damage to the container (for example, cracked jar or lid, leakage,
broken or missing seals)
• The serial number tag does not match the container label
• The freeze indicator in the secondary package has activated
• The storage solution does not completely cover the bioprosthesis
• Accelerated deterioration of the bioprosthesis due to calcific degeneration may occur in:
• Children, adolescents, or young adults
• Patients with altered calcium metabolism (for example, chronic renal failure, or
hyperparathyroidism)
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4.2 Precautions
General
• Do not contact any of the Medtronic CoreValve Evolut PRO system components with
cotton or cotton swabs.
• Do not expose any of the Medtronic CoreValve Evolut PRO system components to
organic solvents, such as alcohol.
• Do not introduce air into the catheter.
• Do not expose the bioprosthesis to solutions other than the storage and rinse solutions.
• Do not add antibiotics or any other substance to either the storage or rinse solutions. Do
not apply antibiotics or any other substance to the bioprosthesis.
• Do not allow the bioprosthesis to dry. Maintain tissue moisture with irrigation or
immersion.
• Do not attempt to repair a damaged bioprosthesis.
• Do not handle or use forceps to manipulate the bioprosthesis leaflet tissue.
• Do not deform the bioprosthesis in excess of what is experienced during crimping,
loading, and implantation.
• Clinical long-term durability has not been established for the bioprosthesis. Evaluate
bioprosthesis performance as needed during patient follow-up.
• The safety and effectiveness of the Medtronic CoreValve Evolut PRO system 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 severe native aortic stenosis
as defined below:
• Symptomatic severe high-gradient aortic stenosis: aortic valve area
≤1.0 cm2 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
• Symptomatic severe low-flow/low-gradient aortic stenosis: aortic valve
area ≤1.0 cm2 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
• 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
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• Patients with liver failure (Child-Pugh Class C)
• With cardiogenic shock manifested by low cardiac output, vasopressor
dependence, or mechanical hemodynamic support
• Patients who are pregnant or breastfeeding
• The safety and effectiveness of a CoreValve Evolut PRO bioprosthesis implanted within
a failed preexisting transcatheter bioprosthesis have not been demonstrated.
• Implanting a CoreValve Evolut PRO bioprosthesis in a degenerated surgical bioprosthetic
valve (transcatheter aortic valve in surgical aortic valve [TAV in SAV]) should be
avoided in the following conditions. The degenerated surgical bioprosthetic valve
presents with a:
• Significant concomitant paravalvular leak (between the prosthesis and the native
annulus), is not securely fixed in the native annulus, or is not structurally intact
(for example, 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/mm3), history of bleeding
diathesis or coagulopathy, or hypercoagulable states
• Congenital unicuspid valve
• Mixed native 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 size <18 mm or >26 mm per the baseline diagnostic
imaging or surgical bioprosthetic aortic annulus size <17 mm or >26 mm
• Transarterial access not able to accommodate a 20 Fr introducer sheath or the
16 Fr equivalent EnVeo inline sheath
• Prohibitive left ventricular outflow tract calcification
• Sinus of Valsalva anatomy that would prevent adequate coronary perfusion
• Significant aortopathy requiring ascending aortic replacement
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• Moderate to severe mitral stenosis
• Severe ventricular dysfunction with left ventricular ejection fraction (LVEF)
<20%
• Symptomatic carotid or vertebral artery disease
• Severe basal septal hypertrophy with an outflow gradient
• A known hypersensitivity or contraindication to any of the following that cannot
be adequately pre-medicated:
• Aspirin or heparin (HIT/HITTS) and bivalirudin
• Ticlopidine and clopidogrel
• Nitinol (titanium or nickel)
• Contrast media
Before use
• Accelerated deterioration due to calcific degeneration of bioprostheses may occur in:
• Children, adolescents, or young adults
• Patients with altered calcium metabolism (for example, chronic renal failure, or
hyperparathyroidism)
• The bioprosthesis size must be appropriate to fit the patient’s anatomy. Proper sizing of
the device is the responsibility of the physician. Refer to Table 1 for available sizes.
Failure to implant a device within the sizing matrix could lead to adverse effects such as
those listed in Section 5.0.
• Patients must present with transarterial access vessels with diameters that are ≥5.5 mm,
or patients must present with an ascending aortic (direct aortic) access site ≥60 mm from
the basal plane.
• Implantation of the bioprosthesis should be avoided in patients with aortic root angulation
(angle between plane of aortic valve annulus and horizontal plane/vertebrae) of >30° for
right subclavian/axillary access or >70° for femoral and left subclavian/axillary access.
• For subclavian access, patients with a patent Left Internal Mammary Artery (LIMA) graft
must present with access vessel diameters of ≥6 mm. Use caution when using the
subclavian/axillary approach in patients with a patent Left Internal Mammary Artery
(LIMA) graft (for left subclavian/axillary approach only) or patent Right Internal
Mammary Artery (RIMA) graft (for right subclavian/axillary approach only).
• For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a
preexisting patent RIMA graft.
• For transfemoral access, use caution in patients who present with multiplanar curvature
of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe
calcification in the aorta and/or vasculature. If ≥2 of these factors are present, consider an
alternative access route to prevent vascular complications.
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• Limited clinical data are available for transcatheter aortic valve replacement in patients
with a congenital bicuspid aortic valve who are deemed to be at low surgical risk.
Anatomical characteristics should be considered when using the valve in this population.
In addition, patient age should be considered as long-term durability of the valve has not
been established.
• Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid
prolonged or repeated exposure to the vapors. Use only with adequate ventilation. If skin
contact occurs, immediately flush the affected area with water (minimum of 15 minutes).
In the event of eye contact, flush with water for a minimum of 15 minutes and seek
medical attention immediately.
• The bioprosthesis and the glutaraldehyde storage solution are sterile. The outside of the
bioprosthesis container is nonsterile and must not be placed in the sterile field.
• Damage may result from forceful handling of the catheter. Prevent kinking of the catheter
when removing it from the packaging.
• This device was designed for single patient use only. Do not reuse, reprocess, or
resterilize this product. Reuse, reprocessing, or resterilization may compromise the
structural integrity of the device and/or create a risk of contamination of the device,
which could result in patient injury, illness, or death.
• Before catheter insertion, remove the loading stylet.
During use
• For direct aortic and subclavian access procedures, care must be exercised when using the
tip-retrieval mechanism to ensure adequate clearance to avoid advancement of the
catheter tip through the bioprosthesis leaflets during device closure.
• For direct aortic access procedures, use a separate introducer sheath; do not use the
EnVeo inline sheath. Maintain the EnVeo inline sheath at the proximal end of the
catheter throughout the procedure.
• Adequate rinsing of the bioprosthesis with sterile saline, as described in the Instructions
for Use, is mandatory before implantation. No other solutions, drugs, chemicals, or
antibiotics should ever be added to the glutaraldehyde or rinse solutions, as irreparable
damage to the leaflet tissue, which may not be apparent under visual inspection, may
result.
• During rinsing, do not touch the leaflets or squeeze the bioprosthesis.
• If a misload is detected, unsheath the bioprosthesis and examine the bioprosthesis for
damage (for example, permanent frame deformation, frayed sutures, or valve damage).
Do not attempt to reload a damaged bioprosthesis; if no issues are found, a second
attempt may be made to load an undamaged bioprosthesis. However, the catheter, LS,
loading tray, and saline must be replaced with new sterile components. Do not load the
bioprosthesis onto the catheter more than 2 times or after it has been inserted into a
patient.
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