6/21/2017
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`Edwards SAPIEN 3 transcatheter heart valve | Edwards Lifesciences
`
`Outcomes
`
`Design
`
`Videos
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`SAPIEN 3 valve
`
`(/)
`
`Therapies
`
`About Us
`
`Transforming the therapy of aortic valve replacement
`Education
`Devices
`Specialty Teams
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`Patients
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`Careers
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`Investors
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`Select your region:
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`United States - English
`
`De머nitive outcomes
`
`Important safety information
`†
`The PARTNER II Trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVR with the SAPIEN 3 valve, AT population
`(n=1,077).
`http://www.edwards.com/devices/Heart­Valves/Transcatheter­Sapien­3#tabs­1
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`(n=1,077).
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`Edwards SAPIEN 3 transcatheter heart valve | Edwards Lifesciences
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`Outcomes
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`Design
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`Videos
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`Edwards SAPIEN valves are the only transcatheter heart valves approved for use in intermediate-
`risk patients in the United States
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`Important safety information
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`http://www.edwards.com/devices/Heart­Valves/Transcatheter­Sapien­3#tabs­1
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`Outcomes
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`Design
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`Videos
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`Important safety information
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`Edwards SAPIEN 3 transcatheter heart valve | Edwards Lifesciences
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`Outcomes
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`Design
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`Videos
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`‡
`The PARTNER II Trial intermediate-risk cohort unadjusted clinical event rates, AT population.
`
`(http://edwardsprod.blob.core.windows.net/media/Default/sapien3/the%20lancet%20article2.pdf)
`
`(http://edwardsprod.blob.core.windows.net/media/Default/sapien3/sapien%203%20patientbrochure%20ir%20doc-0041194b%20.pdf)
`
`(http://edwardsprod.blob.core.windows.net/media/Default/sapien3/머nal%20pp--us-
`Important safety information
`1402_v1_partner2clinicaleventssummary_8.22.16jr.pdf)
`
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`Edwards SAPIEN 3 transcatheter heart valve | Edwards Lifesciences
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`Outcomes
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`Design
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`Videos
`
`The PARTNER Trials represent the largest, most rigorous
`comparative body of evidence in the history of aortic valve
`replacement
`
`Transformational design
`
`Outer sealing skirt
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`Low pro머le access
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`Frame design
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`Proven valve tissue
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`Virtually eliminates moderate or greater paravalvular leak*
`
`*PARTNER II Trial intermediate-risk SAPIEN 3 valve cohort, core lab assessed paravalvular leak at 30 days, n=1,106
`
`Important safety information
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`http://www.edwards.com/devices/Heart­Valves/Transcatheter­Sapien­3#tabs­1
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`Edwards SAPIEN 3 transcatheter heart valve | Edwards Lifesciences
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`Outcomes
`
`Design
`
`Videos
`
`Video library
`
`
`Pause
`
`PARTNER II Trial intermediate-risk SAPIEN 3 valve cohort.
`PARTNER II Trial intermediate-risk SAPIEN 3 valve cohort, core lab assessed paravalvular leak at 30 days, n=1,106
`PARTNER II Trial intermediate-risk SAPIEN 3 valve cohort (VARC II) versus SAPIEN XT valve cohort (VARC I) 30-day results.
`
`* † ‡
`
`Over 99% of valves
`Placed in the intended location
`
`Important safety information
`Important safety information
`Edwards SAPIEN 3 transcatheter heart valve with the Edwards COMMANDER and Certitude delivery systems
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`http://www.edwards.com/devices/Heart­Valves/Transcatheter­Sapien­3#tabs­1
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`Edwards SAPIEN 3 transcatheter heart valve | Edwards Lifesciences
`
`Indications:
`
`Outcomes
`
`Design
`
`Videos
`
`The Edwards SAPIEN 3 transcatheter heart valve (THV), model 9600TFX, and accessories are indicated for patients with symptomatic
`heart disease due to severe native calci머c aortic stenosis who are judged by a Heart Team to be at intermediate or greater risk for open
`surgical therapy (i.e., the patient has comorbidities such that the Heart Team agrees the predicted risk of operative mortality is ≥ 3% at
`30 days).
`
`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.
`
`Warnings: Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of pacing lead perforation.
`There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, as compared to balloon aortic
`valvuloplasty or other standard treatments in high or greater risk patients. 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 lea무ets 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 signi머cant 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
`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 if 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-무exed 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 무uoroscopic
`guidance. Some 무uoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be
`painful, dis머guring, 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.
`
`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. To maintain proper valve lea무et coaptation, do not overin무ate the deployment balloon. Appropriate
`antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and endocarditis. Safety,
`e뙗ectiveness, and durability have not been established for valve-in-valve procedures. Safety and e뙗ectiveness have not been
`established for patients with the following characteristics/comorbidities: non-calci머ed aortic annulus; severe ventricular dysfunction
`with ejection fraction < 20%; congenital unicuspid or congenital bicuspid aortic valve; mixed aortic valve disease (aortic stenosis and
`aortic regurgitation with predominant aortic regurgitation > 3+); pre-existing prosthetic heart valve or prosthetic ring in any position;
`severe mitral annular calci머cation (MAC), severe (> 3+) mitral insu뢜ciency, or Gorlin syndrome; blood dyscrasias de머ned 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; hypertrophic cardiomyopathy with or without obstruction (HOCM); echocardiographic evidence of
`intracardiac mass, thrombus, or vegetation; a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or
`clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated; signi머cant aortic disease, including
`abdominal aortic or thoracic aneurysm de머ned 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 calci머cation and surface
`irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta; access characteristics that
`would preclude safe placement of 14F or 16F Edwards eSheath introducer set, such as severe obstructive calci머cation, severe tortuosity,
`or diameter less than 5.5 mm or 6 mm, respectively; or bulky calci머ed aortic valve lea무ets in close proximity to coronary ostia.
`
`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 de머cit; paralysis; permanent disability;
`respiratory insu뢜ciency 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 e뙗usion or
`cardiac tamponade; embolization including air, calci머c valve material, or thrombus; infection including septicemia and endocarditis;
`heart failure; myocardial infarction; renal insu뢜ciency or renal failure; conduction system defect which may require a permanent
`Important safety information
`pacemaker; arrhythmia; retroperitoneal bleed; AV 머stula or pseudoaneurysm; reoperation; ischemia or nerve injury; restenosis;
`pulmonary edema; pleural e뙗usion; 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
`http://www.edwards.com/devices/Heart­Valves/Transcatheter­Sapien­3#tabs­1
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`hypotension; allergic reaction to anesthesia, contrast media, or device materials; hematoma; syncope; pain or changes at the access
`site; exercise intolerance or weakness; in무ammation; angina; heart murmur; and fever. Additional potential risks associated with the
`Outcomes
`Design
`Videos
`use of the THV, delivery system, and/or accessories include: cardiac arrest; cardiogenic shock; emergency cardiac surgery; cardiac failure
`or low cardiac output; coronary 무ow obstruction/ transvalvular 무ow disturbance; device thrombosis requiring intervention; valve
`thrombosis; device embolization; device migration or malposition requiring intervention; valve deployment in unintended location;
`valve stenosis; structural valve deterioration (wear, fracture, calci머cation, lea무et tear/tearing from the stent posts, lea무et 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; and non-emergent reoperation.
`
`Edwards crimper
`
`Indications: The Edwards Crimper is indicated for use in preparing the Edwards SAPIEN 3 transcatheter heart valve for implantation.
`
`Contraindications: There are no known contraindications.
`
`Warnings: The devices are designed, intended, and distributed for single use only. Do not resterilize or reuse the devices. There is no
`data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing.
`
`Precautions: For special considerations associated with the use of the Edwards Crimper prior to transcatheter heart valve implantation,
`refer to the Edwards SAPIEN 3 transcatheter heart valve Instructions for Use.
`
`Potential adverse events: There are no known potential adverse events associated with the Edwards Crimper.
`
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`Important safety information
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`http://www.edwards.com/devices/Heart­Valves/Transcatheter­Sapien­3#tabs­1
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