Edwards SAPIEN XT User manual

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Edwards SAPIEN XT
Transcatheter Heart Valve with the NovaFlex+ Delivery System
Instructions for Use – Pulmonic
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
Implantation of the Transcatheter Heart Valve (THV) should be performed only by physicians who
have received Edwards Lifesciences training. The implanting physician should be experienced in
balloon valvuloplasty.
Please verify that you have the latest version of the instructions for use prior to using the device
by visiting http://THVIFU.edwards.com or by calling 1.800.822.9837. In order to access the
instructions for use, an IFU Code will be required.
STERILE: The THV is supplied sterilized with glutaraldehyde solution. The delivery system is
supplied sterilized with ethylene oxide gas.
Edwards Lifesciences, the stylized E logo, Edwards, Carpentier-Edwards, Edwards SAPIEN, SAPIEN,
Edwards SAPIEN XT, SAPIEN XT, NovaFlex, NovaFlex+, Qualcrimp, and ThermaFix are trademarks of
Edwards Lifesciences Corporation.
All other trademarks are the property of their respective owners.

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1.0 Device Description
Edwards SAPIEN XT Transcatheter Heart Valve- Model 9300TFX (Figure 1)
The Edwards SAPIEN XT Transcatheter Heart Valve (THV) is comprised of a balloon-expandable,
radiopaque, cobalt-chromium frame, trileaflet bovine pericardial tissue valve, and polyethylene
terephthalate (PET) fabric skirt. The leaflets are treated according to the Carpentier-Edwards ThermaFix
process.
Table 1
THV Size Height
23 mm 14.3 mm
26 mm 17.2 mm
29 mm 19.1 mm
The following table identifies the sizing recommendations for the intended location within the non-
compliant Right Ventricular Outflow Tract (RVOT) conduit:
Table 2
Diameter THV Size
20-23 mm 23 mm
23-26 mm 26 mm
26-29 mm 29 mm
NovaFlex+ Delivery System (Figures 2a, 2b, 2c)
The NovaFlex+ delivery system (usable length 105 cm) is used for delivery of the Edwards SAPIEN XT
THV. The delivery system includes a flex wheel for articulation of the flex catheter, a tapered tip at the
distal end of the delivery system to facilitate advancing to the RVOT, and a balloon catheter for
deployment of the THV. The handle also contains a flex indicator depicting articulation of the flex
catheter, a valve alignment wheel for fine adjustment of the THV during valve alignment, a button that
enables movement between handle positions, and a flush port to flush the flex catheter. The balloon
catheter has radiopaque markers defining the valve alignment position and the working length of the
balloon. A radiopaque double marker proximal to the balloon indicates flex catheter position during
deployment.
Figure 2a. NovaFlex+ Delivery System
Figure 2b. Default Position Figure 2c. Valve Alignment Position

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The inflation parameters for THV deployment are:
Table 3
Model Nominal Balloon
Diameter Nominal Inflation Volume Rated Burst Pressure (RBP)
9355FS23 23 mm 17 mL 7 atm
9355FS26 26 mm 22 mL 7 atm
9355FS29 29 mm 33 mL 7 atm
Qualcrimp Crimping Accessory (Figure 3)
The laminated Qualcrimp crimping accessory (packaged with the NovaFlex+ delivery system and
manufactured in foam) is used during crimping of the THV.
Figure 3
Laminated Qualcrimp
2.0 Indications
The Edwards SAPIEN XT Transcatheter Heart Valve (THV) Systems are indicated for use in pediatric and
adult patients with a dysfunctional, non-compliant Right Ventricular Outflow Tract (RVOT) conduit with a
clinical indication for intervention and:
•pulmonary regurgitation ≥ moderate and/or
•mean RVOT gradient ≥ 35 mmHg.
3.0 Contraindications
The THV and delivery systems are contraindicated in patients with:
•Inability to tolerate an anticoagulation/antiplatelet regimen
•Active bacterial endocarditis
4.0 Warnings
•The devices are designed, intended, and distributed for single use only. Do not resterilize or
reuse the devices. There are no data to support the sterility, nonpyrogenicity, and functionality of
the devices after reprocessing.
•Assessment for coronary compression risk prior to valve implantation is essential to prevent the
risk of severe patient harm.
•Incorrect sizing of the THV may lead to paravalvular leak, migration, embolization and/or RVOT
rupture.
•Accelerated deterioration of the THV may occur in patients with an altered calcium metabolism.
•Prior to delivery, the THV must remain hydrated at all times and cannot be exposed to solutions
other than its shipping storage solution and sterile physiologic rinsing solution. THV leaflets
mishandled or damaged during any part of the procedure will require replacement of the THV.
•Do not use the THV if the tamper evident seal is broken, the storage solution does not completely
cover the THV, the temperature indicator has been activated, the THV is damaged, or the
expiration date has elapsed.
•Do not mishandle the NovaFlex+ delivery system or use it if the packaging or any components
are not sterile, have been opened or are damaged (e.g. kinked or stretched), or the expiration
date has elapsed.

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•Use of excessive contrast media may lead to renal failure. Measure the patient’s creatinine level
prior to the procedure. Contrast media usage should be monitored.
•Patient injury could occur if the delivery system is not un-flexed prior to removal.
•Care should be exercised in patients with hypersensitivities to cobalt, nickel, chromium,
molybdenum, titanium, manganese, silicon, and/or polymeric materials.
•The procedure should be conducted under fluoroscopic guidance. Some fluoroscopically guided
procedures are associated with a risk of radiation injury to the skin. These injuries may be painful,
disfiguring, and long-lasting.
•THV recipients should be maintained on anticoagulant/antiplatelet therapy as determined by their
physician. This device has not been tested for use without anticoagulation.
•Do not add or apply antibiotics to the storage solution, rinse solutions, or to the THV.
5.0 Precautions
•Safety, effectiveness, and durability of the THV have not been established for implantation within
a previously placed surgical or transcatheter pulmonic valve.
•Long-term durability has not been established for the THV. Regular medical follow-up is advised
to evaluate THV performance.
•Glutaraldehyde may cause irritation of the skin, eyes, nose and throat. Avoid prolonged or
repeated exposure to, or breathing of, the solution. Use only with adequate ventilation. If skin
contact occurs, immediately flush the affected area with water; in the event of contact with eyes,
immediately flush the affected area with water and seek immediate medical attention. For more
information about glutaraldehyde exposure, refer to the Material Safety Data Sheet available from
Edwards Lifesciences.
•Patient anatomy should be evaluated to prevent the risk of access that would preclude the
delivery and deployment of the device.
•To maintain proper valve leaflet coaptation, do not overinflate the deployment balloon.
•Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for
prosthetic valve infection and endocarditis.
•Safety and effectiveness have not been established for patients with the following
characteristics/comorbidities:
oEchocardiographic evidence of intracardiac mass, thrombus, or vegetation
oA known hypersensitivity or contraindication to aspirin, heparin or sensitivity to contrast
media, which cannot be adequately premedicated
oPregnancy
oPatients under the age of 10 years
6.0 Potential Adverse Events
Potential risks associated with the overall procedure including potential access complications associated
with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation
and/or general anesthesia, and the use of angiography:
•Death
•Respiratory insufficiency or respiratory failure
•Hemorrhage requiring transfusion or intervention
•Cardiovascular injury including perforation or dissection of vessels, ventricle, myocardium or
valvular structures that may require intervention
•Pericardial effusion or cardiac tamponade
•Embolization including air, calcific valve material or thrombus
•Infection including septicemia and endocarditis
•Heart failure
•Myocardial infarction

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•Renal insufficiency or renal failure
•Conduction system defect Arrhythmia
•Arteriovenous fistula
•Reoperation or reintervention
•Ischemia or nerve injury
•Pulmonary edema
•Pleural effusion
•Bleeding
•Anemia
•Abnormal lab values (including electrolyte imbalance)
•Hypertension or hypotension
•Allergic reaction to anesthesia, contrast media, or device materials
•Hematoma or ecchymosis
•Syncope
•Pain or changes at the access site
•Exercise intolerance or weakness
•Inflammation
•Angina
•Fever
Additional potential risks associated with the use of the THV, delivery system, and/or accessories include:
•Cardiac arrest
•Cardiogenic shock
•Emergency cardiac surgery
•Coronary flow obstruction/transvalvular flow disturbance
•Device thrombosis requiring intervention
•Valve thrombosis
•Device embolization
•Device malposition requiring intervention
•Valve deployment in unintended location
•Structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts,
leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis)
•Paravalvular or transvalvular leak
•Valve regurgitation
•Hemolysis
•Device explants
•Nonstructural dysfunction
•Mechanical failure of delivery system, and/or accessories

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7.0 Directions for Use
7.1 Required Equipment
Table 4
Product Name 23 mm System
(9355NF23A) 26 mm System (9355NF26A) 29 mm System (9355NF29A)
Model
Edwards SAPIEN XT
Transcatheter Heart Valve 9300TFX (23 mm) 9300TFX (26 mm) 9300TFX (29 mm)
NovaFlex+ Delivery System* 9355FS23 9355FS26 9355FS29
Edwards Expandable
Introducer Sheath Set** 916ES23 918ES26 920ES29
Edwards Dilator Kit 9100DKS
Edwards Balloon Catheter
(optional) 9350BC20 (or equivalent) 9350BC23
(or equivalent) 9350BC25 (or equivalent)
Inflation devices provided by Edwards Lifesciences
Edwards Crimper 9350CR
* Includes the Qualcrimp Crimping Accessory and 2-piece Crimp Stopper
** Or other compatible sheath provided by Edwards Lifesciences
Additional Equipment:
•20 cc syringe or larger (x2)
•50 cc syringe or larger
•High-pressure 3-way stopcock (x2)
•Standard cardiac catheterization lab equipment
•Fluoroscopy (fixed, mobile or semi-mobile fluoroscopy systems appropriate for use in
percutaneous coronary interventions)
•Exchange length 0.035 inch (0.89 mm) extra-stiff guidewire
•Sterile rinsing basins, physiological saline, heparinized saline, 15% diluted radiopaque contrast
medium
•Sterile table for THV and device preparation
7.2 THV Handling and Preparation
Follow sterile technique during device preparation and implantation.
7.2.1 THV Rinsing Procedure
Before opening the valve jar, carefully examine for evidence of damage (e.g. a cracked jar or lid, leakage,
or broken or missing seals).
CAUTION: THVs from containers found to be damaged, leaking, without adequate sterilant, or
missing intact seals must not be used for implantation.
Step Procedure
1 Set up two (2) sterile bowls with at least 500 mL of sterile physiological saline to thoroughly rinse the
glutaraldehyde sterilant from the THV.
2 Carefully remove the THV/holder assembly from the jar without touching the tissue. Verify the THV serial
identification number with the number on the jar lid and record in the patient information documents.
Inspect the THV for any signs of damage to the frame or tissue.

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Step Procedure
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Rinse the THV as follows: Place the THV in the first bowl of sterile, physiological saline. Be sure the
saline solution completely covers the THV and holder. With the THV and holder submerged, slowly
agitate (to gently swirl the THV and holder) back and forth for a minimum of 1 minute. Transfer the THV
and holder to the second rinsing bowl of physiological saline and gently agitate for at least one more
minute. Ensure the rinse solution in the first bowl is not used. The THV should be left in the final rinse
solution until needed to prevent the tissue from drying.
CAUTION: Do not allow the THV to come into contact with the bottom or sides of the rinse bowl during
agitation or swirling in the rinse solution. Direct contact between the identification tag and THV is also
to be avoided during the rinse procedure. No other objects should be placed in the rinse bowls. The
THV should be kept hydrated to prevent the tissue from drying.
7.2.2 Prepare the Components
Refer to the Edwards Dilator Kit, Edwards Expandable Introducer Sheath Set, Edwards Crimper and
Edwards Balloon Catheter instructions for use for device preparation.
Step Procedure
1 Visually inspect all components for damage. Ensure the NovaFlex+ delivery system is fully unflexed and
the valve alignment wheel is adjacent to the handle.
2 Flush the flex catheter.
3 Carefully remove the distal balloon cover from the delivery system.
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Remove the stylet from the distal end of the guidewire lumen and set aside. Flush the guidewire lumen
with heparinized saline and insert the stylet back into the distal end of the guidewire lumen.
Note: Failure to insert the stylet back into the guidewire lumen may result in damage to the lumen during
crimping process.
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Place the delivery system into the default position and make sure that the flex catheter tip is covered by
the proximal balloon cover. Unscrew the loader cap from the loader tube and flush the loader cap. Place
the loader cap over the proximal balloon cover and onto the flex catheter with the inside of the cap
oriented towards the distal tip.
6 Press button on handle and bring the device handle adjacent to the Y-connector.
Peel off the proximal balloon cover over the blue section of the balloon shaft.
7 Attach a 3-way stopcock to the balloon inflation port. Partially fill a 50 cc or larger syringe with 15-20 mL
diluted contrast medium and attach to the 3-way stopcock.
8 Fill the inflation device provided by Edwards Lifesciences with excess volume relative to the indicated
inflation volume. Lock the inflation device and attach to the 3-way stopcock.
9 Close the 3-way stopcock to the Inflation device provided by Edwards Lifesciences and de-air the system
using the 50 cc or larger syringe. Slowly release the plunger and leave zero-pressure in the system.
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Close the stopcock to the delivery system. By rotating the knob of the i
nflation device provided by Edwards
Lifesciences, transfer the contrast medium into the syringe to achieve the appropriate volume required to
deploy the THV, per the following:
Delivery System
THV Size
Inflation Volume
Model 9355FS23 23 mm 17 mL
Model 9355FS26 26 mm 22 mL
Model 9355FS29 29 mm 33 mL
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Close the stopcock to the 50 cc or larger syringe. Remove the syringe. Verify that the inflation volume is
correct and lock the Inflation device provided by Edwards Lifesciences.
CAUTION: Maintain the Inflation device provided by Edwards Lifesciences in the locked position
until THV deployment.
7.2.3 Mount and Crimp the THV on the Delivery System
Step Procedure
1 Set up two (2) additional sterile bowls with at least 100
mL of sterile physiological saline to thoroughly rinse
the Qualcrimp crimping accessory.

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2 Completely submerge the Qualcrimp crimping accessory in the first bowl and gently compress it to ensure
complete saline absorption. Slowly swirl the Qualcrimp crimping accessory for a minimum of 1 minute.
Repeat this process in the second bowl.
3 Remove the THV from the holder and remove the ID tag.
4 Attach the 2-piece crimp stopper to the base of the crimper and click into place.
5 With the crimper in the open position, gently place the THV into the crimper aperture. Gradually crimp the
THV until it fits into the Qualcrimp crimping accessory.
6 Place the Qualcrimp crimping accessory over the THV making sure the THV is parallel to the edge of the
Qualcrimp.
7 Place the THV and Qualcrimp crimping accessory in crimper aperture. Insert the delivery system coaxially
within the THV on the Valve Crimp Section (2-3 mm distal to the balloon shaft) with the inflow (fabric cuff
end) of the THV towards the proximal end of the delivery system.
8 Crimp the THV until it reaches the Qualcrimp Stop located on the 2-piece Crimp Stopper.
9 Gently remove the Qualcrimp crimping accessory from the THV. Remove the Qualcrimp Stop from the
Final Stop, leaving the Final Stop in place.
10 Fully crimp the THV until it reaches the Final Stop.
NOTE: Ensure that the Valve Crimp Section remains coaxial within the THV.
11 Repeat the full crimp of the THV for a total of two full crimps.
12 Pull the balloon shaft until it is locked in the default position.
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Flush the loader with heparinized saline. Immediately advance the THV into the loader until the tapered tip
of the delivery system is exposed.
CAUTION: To prevent possible leaflet damage, the THV should not remain fully crimped and/or in
the loader for over 15 minutes.
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Attach the loader cap to the loader, re-flush the delivery system through the flush port and close the
stopcock to the delivery system.
Remove the stylet and flush the guidewire lumen of the delivery system.
CAUTION: Keep the THV hydrated until ready for implantation.
CAUTION: The physician must verify correct orientation of the THV prior to its implantation; its
inflow (fabric cuff end) should be oriented towards the proximal end of the delivery system.
7.3 Valvuloplasty and THV Delivery
Valvuloplasty and THV delivery should be performed under conscious sedation and/or general anesthesia
with hemodynamic monitoring in a catheterization lab/hybrid operating room with fluoroscopic capabilities.
Administer heparin to maintain the ACT at ≥ 250 sec during the procedure.
CAUTION: Use of excessive contrast media may lead to renal failure. Measure the patient’s
creatinine level prior to the procedure. Contrast media usage should be monitored.
CAUTION: Procedure may require venous cut-down with surgical closure of the puncture site due
to the size of the venotomy.
7.3.1 Valvuloplasty
Refer to Edwards Balloon Catheter Instructions for Use (IFU) for information on device preparation and
handling.

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7.3.2 THV Delivery
Step
Procedure
1 Dilate the access site using the Edwards Dilator Kit, if needed. Refer to the Edwards Dilator Kit IFU for information
on device preparation and handling.
2 Ensure the guidewire placement is via the left pulmonary artery, unless precluded by patient anatomy.
3 Prepare and insert the Edwards Expandable Introducer Sheath Set. Refer to the Edwards Expandable Introducer
Sheath Set IFU for information on device preparation and handling.
4 Insert the loader into the sheath until the loader stops.
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Advance the NovaFlex+ delivery system through the sheath until the THV exits the sheath. Retract the loader to
the proximal end of the delivery system.
CAUTION: If accessing femorally or via the iliac, t
he THV should not be advanced through the sheath if the
sheath tip is not past the IVC.
CAUTION: To prevent possible leaflet damage, the THV should not remain in the sheath for over
2 minutes.
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In a straight section of the vena cava, initiate valve alignment by pressing the button, begin pull back of the balloon
catheter, and release the button.
Continue pulling back the balloon catheter until the delivery system locks into the valve alignment position (Refer
to Figure 2c).
Use the Valve Alignment Wheel to position the THV between the valve alignment markers.
CAUTION: Deployment should be within a non-compliant pulmonic conduit (stented or calcific).
CAUTION: Do not turn the Valve Alignment Wheel if the delivery system is not locked in the Valve
Alignment Position.
WARNING: Do not position the THV past the distal Valve Alignment Marker. This will prevent proper valve
deployment.
CAUTION: Maintain guidewire position in the pulmonary artery during valve alignment.
7 Advance the catheter and use the flex wheel, if needed, to advance to the RVOT.
NOTE: The delivery system articulates in a direction opposite from the flush port.
8 If additional working length is needed, remove the loader by unscrewing the loader cap and peeling the loader
tubing from the delivery system.
9 Press the button and retract the Flex Catheter to the Double Marker and position the THV within the RVOT.
10 Verify the correct position of the THV with respect to the RVOT.
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Begin THV deployment:
•Unlock the Inflation device provided by Edwards Lifesciences.
•Slowly deploy the THV by inflating the balloon with the entire volume in the Inflation device provided by Edwards
Lifesciences.
•Assess and reposition the THV as necessary.
•Hold inflation for 3 seconds and confirm that the barrel of the inflation device is empty to ensure complete
inflation of the balloon.
•Deflate the balloon.
Caution: If resistance is experienced during the inflation of the delivery system balloon, do not force the
inflation of the balloon. If the delivery system was rotated during tracking, rotate back to a neutral
position and attempt re-inflation.
7.3.4 System Removal
Step Procedure
1 Unflex the delivery system while retracting the device, if needed. Retract the flex catheter until it locks in the
default position and remove it from the sheath.
CAUTION: Patient injury could occur if the delivery system is not unflexed prior to removal.
2 Remove all devices when the ACT level is appropriate. Refer to the Edwards Expandable Introducer Sheath
Set instructions for use for device removal.
3 Close the access site.

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8.0 How Supplied
STERILE: The THV is supplied sterilized with glutaraldehyde solution. The delivery system is supplied
sterilized with ethylene oxide gas.
8.1 Storage
The THV must be stored at 10 °C to 25 °C (50 °F to 77 °F). Each jar is shipped in an enclosure containing
a temperature indicator to detect exposure of the THV to extreme temperature.
The delivery system should be stored in a cool, dry place.
9.0 MR Safety
MR Conditional
Non-clinical testing has demonstrated that the Edwards SAPIEN XT transcatheter heart valve is MR
Conditional. A patient with this device can be safely scanned in an MR system meeting the following
conditions:
•Static magnetic field of 1.5 tesla or 3 tesla.
•Maximum spatial gradient field of 2500 gauss/cm (25 T/m) or less.
•Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg
(Normal Operating Mode).
Under the scan conditions defined above, the SAPIEN XT THV is expected to produce a maximum
temperature rise of 2.6 °C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends as far as 14.5 mm from the implant
for spin echo images and 30 mm for gradient echo images when scanned in a 3.0 T MRI system. The
implant has not been evaluated in MR systems other than 1.5 or 3.0 T.
10.0 Patient Information
Patient education brochures are provided to each site and should be given to the patient to inform them of
the risks and benefits of the procedure and alternatives in adequate time before the procedure to be read
and discussed with their physician. A copy of this brochure may also be obtained from Edwards
Lifesciences by calling 1.800.822.9837. A patient implant card request form is provided with each THV.
After implantation, all requested information should be completed on this form. The serial number may be
found on the package and on the identification tag attached to the THV. The original form should be returned to
the Edwards Lifesciences address indicated on the form and upon receipt, Edwards Lifesciences will provide
an identification card to the patient.
11.0 Recovered THV and Device Disposal
The explanted THV should be placed into a suitable histological fixative such as 10% formalin or 2%
glutaraldehyde and returned to the company. Refrigeration is not necessary under these circumstances.
Contact Edwards Lifesciences to request an Explant Kit.
Used delivery system may be disposed of in the same manner that hospital waste and biohazardous
materials are handled. There are no special risks related to the disposal of these devices.

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12.0 Clinical Studies
The COMPASSION trial was conducted using the SAPIEN THV, Edwards’ first generation THV, which is
no longer available for distribution. There were no clinical data collected on SAPIEN XT, Edwards’
second generation THV, in the COMPASSION trial. However, there is extensive clinical evidence on
Edwards SAPIEN and SAPIEN XT THVs in the aortic position from the PARTNER I and II trials.
Information on the PARTNER I and II trials may be found on the FDA website:
SAPIEN: http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100041b.pdf
SAPIEN XT: http://www.accessdata.fda.gov/cdrh_docs/pdf13/p130009s034b.pdf
COMPASSION Clinical Trial
The COMPASSION trial was a prospective, non-randomized multi-center study to assess the safety and
effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits
requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic
echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.
The valve sizes used in the COMPASSION trial included the 23 and 26 mm sizes, which were the
only available sizes for the SAPIEN THV. The majority of the data (68.6%) were derived from
patients who received a 23 mm THV.
Enrollment is complete. A total of 81 patients were enrolled into the study. Two enrolled patients were
screen failures and did not undergo the index procedure; therefore, there were 79 patients in the safety
population. An Edwards device was not used nor inserted into the vascular system in 9 patients in the
safety population; therefore, there were 70 patients in the attempted implant population. Only one patient
did not have a SAPIEN THV implanted in the target location; therefore, there were 69 patients in the valve
implant population.
Patient follow-up was performed at one day post-procedure, discharge, 30 days, 6 months, 12 months,
and annually thereafter for 5 years post procedure. Clinical Table 1 shows the time on study for the
Safety Population.
Clinical Table 1: Total Study Follow-up Time
(Safety Population, N=79)
Summary Statistic Results
Total Follow-up Time (years) 2.78±1.74 (79)
3.04 (0.00, 5.31)
Total Patient Years [1] 219.8
Summary statistics:
Continuous measures- Mean ± SD (N); Median (Min, Max)
[1] Total patient years is the sum of the time on study for all patients

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COMPASSION Clinical Data
The demographics and baseline characteristics of the safety population are summarized in Clinical Table
2.
Clinical Table 2: Demographics and Baseline Characteristics (Safety Population, N=79)
Characteristic Statistic
Age - yr 28.0 ± 13.97 (79)
25.0 (10.0, 72.0)
<12 Years(Child) 3 / 79 (3.8%)
12-21 Years (Adolescent) 26 / 79 (32.9%)
>=22 Years (Adult) 50 / 79 (63.3%)
Male sex 52 / 79 (65.8%)
NYHA class
I 18 / 79 (22.8%)
II 36 / 79 (45.6%)
III 23 / 79 (29.1%)
IV 2 / 79 (2.5%)
Primary Indication
Pulmonary Stenosis 7 / 79 (8.9%)
Pulmonary Regurgitation 10 / 79 (12.7%)
Both 62 / 79 (78.5%)
Any Stent Placed (Prior to Study or During Study Procedure) 71 / 78 (91.0%)
Valve size (mm)
23 48 / 70 (68.6%)
26 22 / 70 (31.4%)
Pulmonary Stenosis
None 10 / 79 (12.7%)
Mild 13 / 79 (16.5%)
Moderate 25 / 79 (31.6%)
Severe 31 / 79 (39.2%)
Pulmonary Regurgitation by TTE
None 4 / 78 (5.1%)
Trace 2 / 78 (2.6%)
Mild 1 / 78 (1.3%)
Moderate 5 / 78 (6.4%)
Severe 66 / 78 (84.6%)
Categorical measures-No. / Total no. (%)
Continuous measures- Mean ± SD (N); Median (Min, Max)

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COMPASSION Results
The primary endpoint was freedom from device- or procedure-related death and/or reintervention at 1
year for the valve implant population, which was 97.1% (Clinical Table 3) and met the prespecified
performance goal of 75%. There were no device- or procedure-related patient deaths at one year, and the
incidence of reinterventions solely contributed to the KM estimate.
Clinical Table 3: Freedom from Device- or Procedure-Related Death and/or
Reintervention at 1 Year (Valve Implant Population)
Adverse Event Events Patients
with Event Patients at Risk KM Estimate [1] Standard Error [2]
95%
Confidence
Interval
Device- or Procedure- Related
Death and/or Reintervention 3 2 55 0.971 0.020 (0.889, 0.993)
Device- or Procedure- Related
Death 0 0 57 1.000 0.000 NA
Reintervention 3 2 55 0.971 0.020 (0.889, 0.993)
[1] Kaplan-Meier survival estimates are calculated at 1 year and use the first event per patient. 1 Year is taken to mean 365.25
days. Any event occurring after 1 year is not included.
[2] Standard error of the survival estimate at 1 year.
At 5 years, the freedom from device- or procedure-related death and/or reintervention was 77.1% (Clinical
Figure 1). As there were no device- or procedure-related patient deaths at 5 years, the incidence of
reinterventions solely contributed to the KM estimate.
Clinical Figure 1: Freedom from Device- or Procedure-Related Death and/or Reintervention
to 5 Years (Valve Implant Population)
Primary Endpoint

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Clinical Figure 2 presents the freedom from reintervention to 5 years for the valve implant population,
stratified by type of reintervention: a) freedom from surgical pulmonic valve repair was 98.3% at 1 year
and 91.8% at 5 years; b) freedom from transcatheter pulmonic valve implantation was 97.1% at 1 year
and 85.8% at 5 years; c) freedom from balloon valvuloplasty was 100% at 1 year and 93.7% at 5 years;
and d) freedom from other types of reintervention was 100% at 1 year and 97.9% at 5 years.
Clinical Figure 2: Freedom from Reintervention by Type of Reintervention to 5 Years
(Valve Implant Population)
a) Freedom from Surgical Pulmonic Valve Repair b) Freedom from Transcatheter Pulmonic Valve Repair
c) Freedom from Balloon Valvuloplasty d) Freedom from Other Reintervention
98.3%
91.8%
97.1%
85.8%
100%
93.7%
100%
97.9%

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The secondary endpoints were defined as freedom from Major Adverse Cardiac and Cerebrovascular
Events (MACCE) at 6 months, and functional improvement at 6 months.
Freedom from MACCE at 6 months in the valve implant population was 94.1% (see Clinical Table 4).
Clinical Table 4: Freedom from MACCE at 6 Months (Valve Implant Population)
Adverse Event Events Patients
with Event Patients at Risk KM Estimate [1] Standard
Error [2]
MACCE 4 4 60 0.941 0.028
All-cause mortality 0 0 64 1.000 0.000
Myocardial infarction
0
0
64
1.000
0.000
Reintervention 2 2 62 0.971 0.020
Vascular injury 1 1 63 0.986 0.014
Stroke 0 0 64 1.000 0.000
Pulmonary embolism 1 1 63 0.985 0.015
[1] Kaplan-Meier survival estimates are calculated at 6 months and use the first event per patient. Six months is taken to mean 180
days. Events occurring after 6 months are not included in this analysis.
[2] Standard error of the survival estimate at 6 months.
Overall functional improvement at 6 months for patients in the valve implant population was 87.9%
(Clinical Table 5). A decrease in pulmonary regurgitation to mild or less was observed in 96.2%; improved
pulmonary stenosis mean gradient was 93.8%; functional improvement in NYHA was 92.2%; and
freedom from recurrent pulmonary stenosis was 100%.
Clinical Table 5: Overall Functional Improvement at 6 Months (Valve Implant Population)
Functional Improvement Summary Statistics
Overall Functional Improvement [1] 51 / 58 (87.9%)
Improved Pulmonary Regurgitation [a] 51 / 53 (96.2%)
Improved Mean Gradient [b] 15 / 16 (93.8%)
Functional Improvement in NYHA [c]
47 / 51 (92.2%)
Freedom from Recurrent Pulmonary Stenosis [d] 56 / 56 (100.0%)
Summary statistics: Categorical measures-No. / Total no. (%)
[1] Overall functional improvement, as defined by the following 4 categories:
a) Improved valve function demonstrated by a decrease in PR to mild or less per TTE at 6 months for patients with moderate or
more PR at baseline
b) Improved valve function demonstrated by a decrease in pulmonary stenosis mean gradient to <30mmHg for patients with
pulmonary stenosis mean gradient >30mmHg at baseline.
c) Functional improvement from baseline of ≥ 1 NYHA functional class at 6 months for patients with baseline NYHA functional
class ≥ 2
d) Freedom from recurrent pulmonary stenosis at 6 months
For patients with mild or less PR at baseline only categories b, c, and d were used to determine overall functional improvement. For
patients with pulmonary stenosis mean gradient <30mmHg at baseline only categories a, c, and d were used for overall functional
improvement. For patients with NYHA functional class of <2 at baseline only categories a, b, and d were used to determine overall
functional improvement. For patients treated for indications other than pulmonary stenosis only categories a, b, and c for overall
functional improvement were used.

16
The site-reported serious adverse events are shown in Clinical Table 6.
Clinical Table 6: Incidence of Site-Reported Serious Adverse Events by Study Visit (with CEC adjudication
where available) (Safety Population, (N=79))
Adverse Event
<= 30 Days 31 – 365 Days All Events
Events
Patients with
Event Events
Patients with
Event Events
Patients with
Event
Any Serious Adverse Event 29 3/ 79 (29.1%) 22 13/ 79 (16.5%) 132 38/ 79 (48.1%)
Other 2 2/ 79 (2.5%) 10 6/ 79 (7.6%) 37 13/ 79 (16.5%)
Infection (excluding endocarditis) 1 1/ 79 (1.3%) 3 3/ 79 (3.8%) 12 7/ 79 (8.9%)
CHF 1 1/ 79 (1.3%) 0 0/ 79 (0.0%) 11 4/ 79 (5.1%)
Electrolyte and/or CBC and platelet
counts abnormal 1 1/ 79 (1.3%) 2 1/ 79 (1.3%) 11 2/ 79 (2.5%)
Valve stenosis 0 0/ 79 (0.0%) 1 1/ 79 (1.3%) 9 6/ 79 (7.6%)
Arrhythmia 2 2/ 79 (2.5%) 0 0/ 79 (0.0%) 8 6/ 79 (7.6%)
Endocarditis 1 1/ 79 (1.3%) 2 2/ 79 (2.5%) 5 4/ 79 (5.1%)
Pulmonary artery perforation – rupture
of RVOT conduit 5 5/ 79 (6.3%) 0 0/ 79 (0.0%) 5 5/ 79 (6.3%)
Fever 3 3/ 79 (3.8%) 0 0/ 79 (0.0%) 4 4/ 79 (5.1%)
Hemorrhage requiring transfusion 2 2/ 79 (2.5%) 1 1/ 79 (1.3%) 3 3/ 79 (3.8%)
Syncope 0 0/ 79 (0.0%) 0 0/ 79 (0.0%) 3 3/ 79 (3.8%)
Valve damage or dysfunction 2 2/ 79 (2.5%) 0 0/ 79 (0.0%) 3 3/ 79 (3.8%)
Device migration 2 2/ 79 (2.5%) 0 0/ 79 (0.0%) 2 2/ 79 (2.5%)
Hematoma 2 2/ 79 (2.5%) 0 0/ 79 (0.0%) 2 2/ 79 (2.5%)
Respiratory complication 1 1/ 79 (1.3%) 0 0/ 79 (0.0%) 2 2/ 79 (2.5%)
Anemia 0 0/ 79 (0.0%) 1 1/ 79 (1.3%) 1 1/ 79 (1.3%)
Angina 0 0/ 79 (0.0%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
Atelectasis 1 1/ 79 (1.3%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
Bleeding Event 1 1/ 79 (1.3%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
Dyspnea 0 0/ 79 (0.0%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
Embolism: air or thrombus 0 0/ 79 (0.0%) 1 1/ 79 (1.3%) 1 1/ 79 (1.3%)
Hemolysis 0 0/ 79 (0.0%) 1 1/ 79 (1.3%) 1 1/ 79 (1.3%)
Hemorrhagic event 0 0/ 79 (0.0%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
Hypotension 1 1/ 79 (1.3%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
Ischemia 0 0/ 79 (0.0%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
MI 0 0/ 79 (0.0%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
Neurological Event (including TIA,
stroke and psychomotor deficit) 0 0/ 79 (0.0%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
Non-emergent reoperation 0 0/ 79 (0.0%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
Nonstructural valve dysfunction 1 1/ 79 (1.3%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
Thromboembolism 0 0/ 79 (0.0%) 0 0/ 79 (0.0%) 1 1/ 79 (1.3%)
Summary statistics:
Categorical measures-No. / Total no. (%)
Seriousness was determined by the CEC for these events if they have been adjudicated and the site otherwise.
Note: The rates given in the All Events columns are cumulative based on all events reported by all patients up to their current
follow up time including 10 patients who completed 5 year follow-up.
Two patients experienced a device migration (2/79, 2.5%) early in the trial. The instructions for use were
modified; no other device migrations occurred in the trial after this modification. SAE RVOT conduit
ruptures occurred in 5/79 (6.3%) patients. Please note that all 5 ruptures were related to balloon
valvuloplasty or placement of a pre-stent. No ruptures occurred during placement of the SAPIEN THV.

17
The key CEC-adjudicated adverse events to 5 years are presented in Clinical Table 7.
Clinical Table 7: CEC-Adjudicated Endpoint Adverse Events (Valve Implant Population, N=69)
Outcome [a]
30 Days
(Patients at
risk=69) [k]
1 Year
(Patients at
risk=57) [k]
2 Year
(Patients at
risk=45) [k]
3 Years
(Patients at
risk=41) [k]
4 Years
(Patients at
risk=23) [k]
5 Years
(Patients at
risk=9) [k]
KM
Survival
Estimate
[j]
Patients
With
Event
KM
Survival
Estimate
[j]
Patients
With
Event
KM
Survival
Estimate
[j]
Patients
With
Event
KM
Survival
Estimate
[j]
Patients
With
Event
KM
Survival
Estimate
[j]
Patients
With
Event
KM
Survival
Estimate
[j]
Patients
With
Event
Valve Dysfunction [b] 0.957 3 0.942 4 0.885 7 0.772 12 0.707 14 0.657 15
MACCE [c] 0.971 2 0.941 4 0.919 5 0.825 9 0.751 11 0.697 12
Device or Procedure
Related Death or
Reintervention
0.971 2 0.971 2 0.971 2 0.900 5 0.826 7 0.771 8
Reintervention 0.971 2 0.971 2 0.971 2 0.900 5 0.826 7 0.771 8
Transcatheter
pulmonic valve
implantation (TPVI or
V-in-V)
0.971 2 0.971 2 0.971 2 0.947 3 0.912 4 0.858 5
Endocarditis (site) [d] 0.986 1 0.970 2 0.970 2 0.970 2 0.933 3 0.871 4
Surgical Pulmonic
Valve Repair /
Replacement
1.000 0 0.983 1 0.983 1 0.960 2 0.918 3 0.918 3
Balloon valvuloplasty 1.000 0 1.000 0 1.000 0 0.976 1 0.937 2 0.937 2
Deaths 1.000 0 1.000 0 0.978 1 0.978 1 0.978 1 0.978 1
Death from
cardiovascular cause
[e]
1.000 0 1.000 0 0.978 1 0.978 1 0.978 1 0.978 1
Myocardial infarction 1.000 0 1.000 0 1.000 0 0.976 1 0.976 1 0.976 1
Other reintervention
[f] 1.000 0 1.000 0 0.979 1 0.979 1 0.979 1 0.979 1
Vascular Injury [g] 1.000 0 0.986 1 0.986 1 0.986 1 0.986 1 0.986 1
Pulmonary embolism 1.000 0 0.985 1 0.985 1 0.985 1 0.985 1 0.985 1
Device or procedure
related death 1.000 0 1.000 0 1.000 0 1.000 0 1.000 0 1.000 0
Stroke 1.000 0 1.000 0 1.000 0 1.000 0 1.000 0 1.000 0
Study Valve Stent
Fracture (site) [d,h] 1.000 0 1.000 0 1.000 0 1.000 0 1.000 0 1.000 0
Summary statistics: n/N (%) of Patients
[a] CEC-adjudicated
[b] Valve Dysfunction is a non-hierarchical composite of the following events: all-cause mortality, surgical pulmonary valve replacement,
valve frame fracture, recurrent pulmonary stenosis, moderate/severe regurgitation and reintervention.
[c] MACCE is a non-hierarchical composite of the following events: all-cause mortality, myocardial infarction, reintervention, vascular injury,
stroke and pulmonary embolism.
[d] Site-reported events.
[e] Deaths from unknown causes were assumed to be deaths from cardiovascular causes.
[f] The other consists of a patient that underwent successful stenting of stenotic, surgically placed conduit.
[g] Vascular injury resulting in the need for an unplanned vascular intervention.
[h] A study valve fracture is a fracture of the frame of the study valve.
[j] Kaplan-Meier freedom from event rates are provided at the time point specified. Any events occurring after are not included.
[k] Patients at risk are the number of patients with at least as many days on study as the time point. 1 Year is taken to mean 365.25 days.

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Valve Frame Fractures
No patient had a study valve frame fracture.
Valve Dysfunction
Valve dysfunction is a non-hierarchical composite of all-cause mortality, surgical pulmonary valve
replacement, valve frame fracture, recurrent pulmonary stenosis, moderate/severe regurgitation and
reintervention. Clinical Figure 4 presents the freedom from valve dysfunction, which was 94.2% at 1 year
and 65.7% at 5 years.
Clinical Figure 4: Freedom from Valve Dysfunction to 5 Years (Valve Implant Population)

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All Cause Mortality
Clinical Figure 5 presents the freedom from all-cause mortality for the valve implant population, which was
100% at 1 year and 97.8% at 5 years.
Clinical Figure 5: Freedom from All-Cause Mortality to 5 Years (Valve Implant Population)

20
Endocarditis
Clinical Figure 6 presents the freedom from endocarditis for the safety population, which was 97.3% at 1
year and 86.1% at 5 years. Patients that were pre-stented had an observed rate of endocarditis of 4.2%
(3/71) whereas patients that were not pre-stented had no reported endocarditis (0/7). Due to the small
number of patients that were not pre-stented, no statistical conclusions may be made from this data.
Clinical Figure 6: Freedom from Endocarditis at 5 Years (Safety Population, N=79)