Co
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`Edwards SAPIEN 3
`Transcatheter Heart Valve with the Edwards Commander Delivery
`System
`
`
`
`Instructions for Use
`
`CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
`Implantation of the transcatheter heart valve should be performed only by physicians who have
`received Edwards Lifesciences training. The implanting physician should be experienced in
`balloon aortic 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,
`eSheath introducer set, and crimper are supplied sterilized with ethylene oxide gas.
`
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`Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Edwards Commander,
`Edwards eSheath, Edwards SAPIEN, Edwards SAPIEN 3, eSheath, Qualcrimp, PARTNER, PARTNER II,
`SAPIEN, SAPIEN 3, TFX and ThermaFix are trademarks of Edwards Lifesciences Corporation.
`All other trademarks are the property of their respective owners.
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`Page 1 of 30
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`1.0 Device Description
`• Edwards SAPIEN 3 Transcatheter Heart Valve- Model 9600TFX (Figure 1)
`The Edwards SAPIEN 3 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
`Valve Size
`20 mm
`23 mm
`26 mm
`29 mm
`
`Height
`15.5 mm
`18 mm
`20 mm
`22.5 mm
`
`
`
`
`Table 2
`Native Valve Annulus Size
`(CT)
`
`Area
`
`Native Valve Annulus Size
`(TEE)
`
`THV Size
`
`Area Derived
`Diameter
`273 – 345 mm2
`20 mm
`18.6-21 mm
`16-19 mm
`338 – 430 mm2
`23 mm
`20.7-23.4 mm
`18-22 mm
`430 – 546 mm2
`26 mm
`23.4-26.4 mm
`21-25 mm
`540 – 683 mm2
`29 mm
`26.2-29.5 mm
`24-28 mm
`THV size recommendations are based on native valve annulus size, as measured by transesophageal
`echocardiography (TEE) or computed tomography (CT). Patient anatomical factors and multiple imaging
`modalities should be considered during THV size selection. Note: Risks associated with undersizing and
`oversizing should be considered.
`
`
`
` •
`
` Edwards Commander Delivery System (Figure 2)
`The Edwards Commander delivery system (usable length 105 cm) is used for delivery of the Edwards
`SAPIEN 3 transcatheter heart valve and consists of a Flex Catheter to aid in valve alignment to the
`balloon, tracking, and positioning of the THV. The delivery system includes a tapered tip to facilitate
`crossing of the native valve. The handle contains a Flex Wheel to control flexing of the Flex Catheter, and
`a Balloon Lock and Fine Adjustment Wheel to facilitate valve alignment and positioning of the valve within
`the native annulus. A stylet is included within the guidewire lumen of the delivery system. The Balloon
`Catheter has radiopaque Valve Alignment Markers defining the working length of the balloon. A
`radiopaque Center Marker in the balloon is provided to help with valve positioning. A radiopaque Triple
`Marker proximal to the balloon indicates the Flex Catheter position during deployment. The inflation
`parameters for THV deployment are:
`
`
`Table 3
`Nominal
`Balloon
`Diameter
`20 mm
`23 mm
`26 mm
`29 mm
`
`Nominal
`Inflation
`Volume
`11 mL
`17 mL
`23 mL
`33 mL
`
`Rated Burst
`Pressure
`(RBP)
`7 atm
`7 atm
`7 atm
`7 atm
`
`Model
`
`9600LDS20
`9600LDS23
`9600LDS26
`9600LDS29
`
`
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`2
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`Figure 2 Edwards Commander Delivery System
`
`
`• Qualcrimp Crimping Accessory (Figure 3)
`The Qualcrimp crimping accessory (packaged with the Edwards Commander delivery system) is used
`during crimping of the THV.
`
`Figure 3
`
`
`
`
`
`Laminated Qualcrimp
`
`• Edwards eSheath Introducer Set
`
`Refer to the Edwards eSheath Introducer Set for device description.
`
`• Edwards Crimper
`
`Refer to the Edwards Crimper instructions for use for device description.
`
`
`
`Indications
`2.0
`The Edwards SAPIEN 3 Transcatheter Heart Valve (THV), model 9600TFX, and accessories are
`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 at high or
`greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a
`≥15% risk of mortality at 30 days).
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`3.0 Contraindications
`The THV and delivery systems are contraindicated in patients who cannot tolerate an
`anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections.
`
`4.0 Warnings
`• Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of
`pacing lead perforation.
`
`• There is an increased risk of stroke in transcatheter aortic valve replacement procedures, as
`compared to balloon aortic valvuloplasty or other standard treatments.
`• 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.
`• Incorrect sizing of the THV may lead to paravalvular leak, migration, embolization and/or annular
`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.
`• Caution should be exercised in implanting a THV in patients with clinically significant coronary artery
`disease.
`• Patients with pre-existing mitral valve devices should be carefully assessed prior to implantation of
`the THV to ensure proper THV positioning and deployment.
`• 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 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.
`• 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, except when
`contraindicated, 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
`• 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, seek immediate
`medical attention. For more information about glutaraldehyde exposure, refer to the Material Safety
`Data Sheet available from Edwards Lifesciences.
`
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`• 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, effectiveness, and durability have not been established for valve-in-valve procedures.
`
`• Safety and effectiveness have not been established for patients with the following
`characteristics/comorbidities:
`o Non-calcified aortic annulus
`o Severe ventricular dysfunction with ejection fraction < 20%
`o Congenital unicuspid or congenital bicuspid aortic valve
`o Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic
`regurgitation > 3+)
`o Pre-existing prosthetic heart valve or prosthetic ring in any position
`o Severe mitral annular calcification (MAC), severe (> 3+) mitral insufficiency, or Gorlin
`syndrome
`o Blood dyscrasias defined as: leukopenia (WBC < 3000 cells/mL), acute anemia (Hb < 9
`g/dL), thrombocytopenia (platelet count < 50,000 cells/mL), or history of bleeding
`diathesis or coagulopathy
`o Hypertrophic cardiomyopathy with or without obstruction (HOCM)
`o Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
`o A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid™), or
`clopidogrel (Plavix™), or sensitivity to contrast media, which cannot be adequately premedicated
`o Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal
`luminal diameter 5 cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma
`(especially if thick [> 5 mm], protruding, or ulcerated) or narrowing (especially with calcification
`and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of
`the thoracic aorta
`o Access characteristics that would preclude safe placement of 14F or 16F Edwards eSheath
`Introducer Set, such as severe obstructive calcification, severe tortuosity or diameter less than
`5.5 mm or 6 mm, respectively
`o Bulky calcified aortic valve leaflets in close proximity to coronary ostia
`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
`• Stroke/transient ischemic attack, clusters or neurological deficit
`• Paralysis
`• Permanent disability
`• 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
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`• Embolization including air, calcific valve material or thrombus
`• Infection including septicemia and endocarditis
`• Heart failure
`• Myocardial infarction
`• Renal insufficiency or renal failure
`• Conduction system defect which may require a permanent pacemaker
`• Arrhythmia
`• Retroperitoneal bleed
`• AV fistula or pseudoaneurysm
`• Reoperation
`• Ischemia or nerve injury
`• Restenosis
`• 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
`• Syncope
`• Pain or changes at the access site
`• Exercise intolerance or weakness
`• Inflammation
`• Angina
`• Heart murmur
`• Fever
`Additional potential risks associated with the use of the THV, delivery system, and/or accessories include:
`• Cardiac arrest
`• Cardiogenic shock
`• Emergency cardiac surgery
`• Cardiac failure or low cardiac output
`• Coronary flow obstruction/transvalvular flow disturbance
`• Device thrombosis requiring intervention
`• Valve thrombosis
`• Device embolization
`• Device migration or malposition requiring intervention
`• Valve deployment in unintended location
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`• Valve stenosis
`• 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)
`• Device degeneration
`• Paravalvular or transvalvular leak
`• Valve regurgitation
`• Hemolysis
`• Device explants
`• Nonstructural dysfunction
`• Mechanical failure of delivery system, and/or accessories
`• Non-emergent reoperation
`7.0 Directions for Use
`
`7.1 Required Equipment
`
`
`Product Name
`
`20 mm System
`(9600CM20A)
`
`9600TFX (20 mm)
`
`Edwards SAPIEN 3
`Transcatheter Heart Valve
`Edwards Commander Delivery
`System*
`Edwards eSheath Introducer
`Set**
`
`Table 4
`23 mm System
`(9600CM23A)
`
`Model
`9600TFX (23 mm)
`
`26 mm System
`(9600CM26A)
`
`29 mm System
`(9600CM29A)
`
`9600TFX (26 mm)
`
`9600TFX (29 mm)
`
`9600LDS20
`
`9600LDS23
`
`9600LDS26
`
`9600LDS29
`
`914ES
`
`914ES
`
`914ES
`
`916ES
`
`Edwards Balloon Catheter
`
`9350BC16
`
`9350BC20
`
`9350BC23
`
`9350BC25
`
`
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`
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`Inflation devices provided by Edwards Lifesciences
`9600CR
`Edwards Crimper
`* Includes the Qualcrimp Crimping Accessory,2-piece Crimp Stopper and loader
`** 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)
`• Transesophageal or transthoracic echocardiography capabilities
`• Exchange length 0.035 inch (0.89 mm) extra-stiff guidewire
`• Temporary pacemaker (PM) and pacing lead
`• 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.
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`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
`
`2
`
`3
`
`Set up two (2) sterile bowls with at least 500 mL of sterile physiological saline to thoroughly rinse the
`glutaraldehyde sterilant from the THV.
`
`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.
`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 eSheath Introducer Set, Edwards Crimper and Edwards Balloon Catheter
`instructions for use for device preparation.
`
`Step
`
`1
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`2
`3
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`4
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`5
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`6
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`7
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`8
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`9
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`Procedure
`Visually inspect all components for damage. Ensure the Edwards Commander delivery system is fully
`unflexed and the balloon catheter is fully advanced in the flex catheter.
`
`WARNING: To prevent possible damage to the balloon shaft, ensure that the proximal end of the
`balloon shaft is not subjected to bending.
`Flush the flex catheter.
`Carefully remove the distal balloon cover from the delivery system.
`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.
`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.
`Fully advance the balloon catheter in the flex catheter.
`Peel off the proximal balloon cover over the blue section of the balloon shaft.
`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.
`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.
`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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`Step
`
`Procedure
`Close the stopcock to the delivery system. By rotating the knob of the inflation 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:
`
`10
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`11
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`Delivery System
`Model 9600LDS20
`Model 9600LDS23
`Model 9600LDS26
`Model 9600LDS29
`
`THV Size
`20 mm
`23 mm
`26 mm
`29 mm
`
`Inflation Volume
`11 mL
`17 mL
`23 mL
`33 mL
`
`
`
`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.
`
`1
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`2
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`3
`4
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`5
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`6
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`7
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`8
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`9
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`7.2.3 Mount and Crimp the THV on the Delivery System
`Step
`Procedure
`Set up two (2) additional sterile bowls with at least 100 mL of sterile physiological saline to thoroughly
`rinse the Qualcrimp crimping accessory.
`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.
`Remove the THV from the holder and remove the ID tag.
`Attach the 2-piece crimp stopper to the base of the crimper and click into place.
`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.
`Place the Qualcrimp crimping accessory over the THV making sure the THV is parallel to the edge of
`the Qualcrimp.
`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 distal end of the delivery system.
`Crimp the THV until it reaches the Qualcrimp Stop located on the 2-piece Crimp Stopper.
`Gently remove the Qualcrimp crimping accessory from the THV. Remove the Qualcrimp Stop from
`the Final Stop, leaving the Final Stop in place.
`Fully crimp the THV until it reaches the Final Stop.
`NOTE: Ensure that the Valve Crimp Section remains coaxial within the THV.
`Repeat the full crimp of the THV two more times for a total of three full crimps.
`Pull the balloon shaft and lock in the default position.
`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.
`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 distally towards the tapered tip.
`
`10
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`11
`12
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`13
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`14
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`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 and
`echocardiographic imaging 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 an arterial cut-down with surgical closure of the puncture site
`due to the size of the arteriotomy.
`7.3.1 Baseline Parameters
`Step
`Procedure
`
`1
`
`2
`
`3
`
`4
`
`Perform a supra-aortic angiogram with fluoroscopic view perpendicular to the aortic valve.
`
`Evaluate the distance of the left and right coronary ostia from the aortic annulus in relation to the THV
`frame height.
`
`Introduce a pacemaker (PM) lead until its distal end is positioned in the right ventricle.
`
`Set the stimulation parameters to obtain 1:1 capture, and test pacing.
`
`7.3.2 Valvuloplasty
`
`Refer to Edwards Balloon Catheter Instructions for Use (IFU) for information on device
`preparation and handling.
`Note: Rapid ventricular pacing should be performed when using the Edwards Balloon Catheter for
`valvuloplasty prior to aortic transcatheter valve implantation.
`
`After placement of the balloon at the intended site, begin rapid ventricular pacing. Once the systolic blood
`pressure has decreased to 50 mmHg or below, balloon inflation can commence.
`
`1
`
`2
`
`CAUTION: THV implantation should not be carried out if the balloon cannot be fully inflated during
`valvuloplasty.
`7.3.3 THV Delivery
`Step
`Procedure
`Prepare and insert the Edwards eSheath Introducer Set. Refer to the Edwards eSheath Introducer Set IFU
`for information on device preparation and handling.
`Insert the loader into the sheath until the loader stops.
`Advance the Edwards Commander delivery system, with the Edwards logo facing up, through the sheath
`until the THV exits the sheath. Retract the loader to the proximal end of the delivery system.
`NOTE: Maintain the proper orientation of the flex catheter (with the Edwards logo facing up)
`throughout the procedure.
`CAUTION: If accessing femorally or via the iliac, the THV should not be advanced through the sheath
`if the sheath tip is not past the aortic bifurcation.
`CAUTION: To prevent possible leaflet damage, the THV should not remain in the sheath for over
`5 minutes.
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`3
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`10
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`Step
`
`4
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`5
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`6
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`7
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`8
`
`9
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`10
`
`11
`
`Procedure
`In a straight section of the aorta, initiate valve alignment by disengaging the Balloon Lock and pulling the
`balloon catheter straight back until part of the Warning Marker is visible. Do not pull past the Warning
`Marker.
`WARNING: To prevent possible damage to the balloon shaft, ensure that the proximal end of the
`balloon shaft is not subjected to bending.
`Engage the Balloon Lock.
`Use the Fine Adjustment Wheel to position the THV between the valve alignment markers.
`CAUTION: Do not turn the Fine Adjustment Wheel if the Balloon Lock is not engaged.
`WARNING: Do not position the THV past the distal Valve Alignment Marker. This will prevent proper
`valve deployment.
`CAUTION: Maintain guidewire position in the left ventricle during valve alignment.
`Advance the catheter and use the flex wheel, if needed, and cross the aortic valve.
`NOTE: Verify the Edwards logo is facing up. The delivery system articulates in a direction opposite
`from the flush port.
`
`If additional working length is needed, remove the loader by unscrewing the loader cap and peeling the
`loader tubing from the delivery system.
`
`Disengage the Balloon Lock and retract the tip of the Flex Catheter to the center of the Triple Marker.
`Engage the Balloon Lock.
`Verify the correct position of the THV with respect to the aortic annulus.
`As necessary, utilize the Flex Wheel to adjust the co-axiality of the THV and the Fine Adjustment Wheel to
`adjust the position of the THV.
`Before deployment, ensure that the THV is correctly positioned between the Valve Alignment Markers and
`the Flex Catheter tip is over the Triple Marker.
`Begin THV deployment:
`• Unlock the Inflation device provided by Edwards Lifesciences.
`• Begin rapid pacing; once systolic blood pressure has decreased to 50 mmHg or below, balloon inflation
`can commence.
`• Deploy the THV by inflating the balloon with the entire volume in the Inflation device provided by
`Edwards Lifesciences, hold for 3 seconds and confirm that the barrel of the inflation device is empty to
`ensure complete inflation of the balloon.
`• Deflate the balloon. When the balloon catheter has been completely deflated, turn off the pacemaker.
`
`7.3.4 System Removal
`Step
`Procedure
`Unflex the delivery system while retracting the device, if needed. Verify that the Flex Catheter tip is
`locked over the Triple Marker and remove the delivery system from the sheath.
`CAUTION: Patient injury could occur if the delivery system is not unflexed prior to removal.
`
`1
`
`2
`
`3
`
`Remove all devices when the ACT level is appropriate. Refer to the Edwards Expandable Introducer
`Sheath Set instructions for use for device removal.
`
`Close the access site.
`
`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.
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`9.0 MR Safety
`
` MR Conditional
`The Edwards SAPIEN 3 transcatheter heart valve has been determined to be 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 3 transcatheter heart valve is expected to produce
`a maximum temperature rise of 3.0 ºC after 15 minutes of continuous scanning.
`
`In non-clinical testing, the image artifact caused by the device extends as far as 10 mm from the implant
`for spin echo images and 30 mm for gradient echo images when scanned in a 3.0T MRI system.
`
`The implant has not been evaluated in MR systems other than 1.5 or 3.0T.
`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
`transcatheter heart valve. 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 transcatheter
`heart valve. 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.
`12.0 Clinical Studies
`SUMMARY OF PRIMARY CLINICAL STUDY
`
`Primary Clinical Study Design
`
`The PIIS3HR Cohort of the PARTNER II trial was a single arm, non-randomized, historical-controlled
`study to compare the third generation Edwards SAPIEN 3 THV system with the first generation Edwards
`SAPIEN THV system in patients who either have high risk for surgery or cannot undergo surgery
`(inoperable). The valve sizes used in the PIIS3HR trial included only the 23, 26 and 29 mm sizes. The 20
`mm valve size was introduced into the trial after enrollment was completed with the three larger sizes,
`thus a separate nested registry, NR7, with identical inclusion/exclusion criteria as the PIIS3HR Cohort
`except for the aortic annulus diameter, was created to collect data for the 20 mm valve. Data from the
`PIIS3HR cohort and NR7 are pooled for the statistical analyses. For convenience, this combined cohort is
`referred to as “PIIS3HR” hereafter.
`
`The database included 583 eligible patients enrolled at 29 investigational sites in the U.S.
`
`The study used an independent Data Safety Monitoring Board (DSMB) that was instructed to notify
`Edwards Lifesciences of any safety or compliance issues, a Clinical Events Committee (CEC) that was
`responsible for adjudicating endpoint related events reported during the trial per a priori established
`
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`VARC 2 definitions,[1] an ECG core laboratory for independent analysis of rhythm, and an
`echocardiographic core laboratory for independently analyzing all echocardiograms.
`
`Accountability
`
`All 583 eligible patients were successfully implanted with a SAPIEN 3 THV, which constitutes the Valve
`Implant (VI) population. Among the VI population, 491 patients were implanted via the transfemoral (TF)
`access route, and 92 patients via the transapical (TA) or transaortic (TAo) access route.
`Table 5: Patient Accountability
`Overall
`TF
`491
`583
`
`TA /TAo
`92
`
`
`Eligible Patient
`Population (EPP)
`Valve Implant
`92
`491
`583
`(VI) Population
`Eligible Patient Population (EPP) consists of all enrolled patients who received
`treatment assignment from the database and entered into the catheterization
`laboratory/hybrid suite and who remained eligible to receive the implant.
`
`Valve Implant (VI) Population consists of all enrolled patients who received a
`SAPIEN 3 implant, and retained the valve upon leaving the catheterization
`laboratory/hybrid suite.
`
`
`Study Population Demographics and Baseline Parameters
`
`The demographics of the study population are summarized in Table 6, which are typical of a TAVR study
`performed in the U.S.
`
`
`Table 6: Patient Demographics and Baseline Characteristics - PIIS3HR VI Population
`Overall
`TF
`TA/TAo
`Characteristic
`(N= 583)
`(N= 491)
`(N= 92)
`Age, yr
`82.6 ± 8.1
`82.8 ± 8.2
`81.7 ± 7.5
`Male sex, no. (%)
`338 (58.0%) 277 (56.4%) 61 (66.3%)
`STS score
`8.6 ± 3.7
`8.4 ± 3.5
`10.0 ± 4.3
`New York Heart Association (NYHA) class, no. (%):
`
`
`
` I/II
`58 (9.9%)
`51 (10.4%)
`7 (7.6%)
` III/IV
`525 (90.1%) 440 (89.6%) 85 (92.4%)
`Coronary artery disease, no. (%)
`444 (76.2%) 360 (73.3%) 84 (91.3%)
`Previous myocardial infarction, no. (%)
`117 (20.1%)
`87 (17.7%)
`30 (32.6%)
`Previous intervention, no. (%)
`
`
`
` Coronary-artery bypass grafting (CABG)
`193 (33.1%) 145 (29.5%) 48 (52.2%)
` Percutane