Medtronic EVPROPLUS-26US Instructions for Use
Evolut™ PRO+ System
Evolut™ PRO+ Transcatheter Aortic Valve
Evolut™ PRO+ Delivery Catheter System
Evolut™ PRO+ Loading System
Caution: Implantation of the Medtronic Evolut™ PRO+ system should be performed only
by physicians who have received Medtronic 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™, 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
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EVPROPLUS-23US
23 mm
17b/18 mm to 20 mm
53.4c/56.5 mm to 62.8 mm
EVPROPLUS-26US
26 mm
20 mm to 23 mm
62.8 mm to 72.3 mm
EVPROPLUS-29US
29 mm
23 mm to 26 mm
72.3 mm to 81.7 mm
EVPROPLUS-34US
34 mm
26 mm to 30 mm
81.7 mm to 94.2 mm
1.0 Device description
The Medtronic Evolut™ PRO+ system is a recapturable transcatheter aortic valve
replacement system, which includes the Evolut PRO+ transcatheter aortic valve
(bioprosthesis)a, the delivery catheter system (catheter), and the loading system (LS).
1.1 Evolut PRO+ transcatheter aortic valve (bioprosthesis)
Figure 1: 23 mm
bioprosthesis
Figure 2: 26 mm
bioprosthesis
Figure 3: 29 mm
bioprosthesis
Figure 4: 34 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)
a
The terms “bioprosthesis” and “transcatheter aortic valve” are synonymous terms and are used interchangeably
throughout the document to refer to the Evolut PRO+ device.
b
Diameter for surgical aortic valve (SAV)
c
53.4 mm for surgical bioprosthetic aortic annulus
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1.2 Delivery catheter system (catheter)
The catheter comes in different sizes. Refer to Table 2 for system compatibility. Refer to
Figure 5 and Figure 6 for catheter components.
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 Evolut
PRO+ 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 23-29 mm
catheter model is compatible with sheaths that can accommodate an 18 Fr (6.00 mm) device.
The 34 mm catheter model is compatible with sheaths that can accommodate a 22 Fr (7.33
mm) device.
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.
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Figure 5: Catheter
1. Catheter tip
2. Capsule (Model D-EVPROP2329US: 18 Fr [6.0 mm] outer diameter [OD]; Model D-
EVPROP34US: 22 Fr [7.33 mm] OD)
3. Catheter shaft
4. Stability layer
5. Model D-EVPROP2329US: 14 Fr equivalent Evolut PRO+ inline sheath (18 Fr [6.0
mm] OD); Model D-EVPROP34US: 18 Fr equivalent Evolut PRO+ inline sheath (22
Fr [7.33 mm] OD)
6. Evolut PRO+ 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
Figure 6: Catheter
1. 7.6 cm (Model D-EVPROP2329US); 7.7 cm Model D-EVPROP34US
2. 107 cm
3. 88.6 cm
4. 30 cm
4
Figure 7: Catheter distal tray
Figure 8: 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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EVPROPLUS-23US
EVPROPLUS-26US
EVPROPLUS-29US
EVPROPLUS-34US
L-EVPROP34US
D-EVPROP34US
1.3 Loading system (LS)
The LS compresses the bioprosthesis into the catheter. The LS comes in different sizes. Refer
to Table 2 for system compatibility. Refer to Figure 9 for components.
Figure 9: Evolut PRO+ LS
1. Catheter tip guide tube
2. Inflow cone
3. Backplate
4. Outflow cone
5. Capsule guide tube
6. Locking collar
Table 2: System compatibility
Bioprosthesis model Compatible LS models Compatible catheter models
L-EVPROP2329US D-EVPROP2329US
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2.0 Indications
The Medtronic 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 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 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 Evolut PRO+ system should be performed only by
physicians who have received Medtronic 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 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 Evolut PRO+ system components with cotton or
cotton swabs.
• Do not expose any of the Medtronic 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 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 the Evolut PRO+ bioprosthesis implanted within a failed
preexisting transcatheter bioprosthesis have not been demonstrated.
• Implanting the 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 >30 mm per the baseline diagnostic
imaging or surgical bioprosthetic aortic annulus size <17 mm or >30 mm
• Transarterial access not able to accommodate the following:
• 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ inline
sheath.
• 18 Fr introducer sheath or the 14 Fr equivalent Evolut PRO+ inline sheath.
• Prohibitive left ventricular outflow tract calcification
• Sinus of Valsalva anatomy that would prevent adequate coronary perfusion
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