You refuse to compromise.
We couldn’t agree more.

Sapien 3 Ultra valve

Edwards SAPIEN 3 Ultra valve

With so much at stake, you set a Higher Standard. Delivering the excellent outcomes you demand, perfecting the pathway and controlling for the future.

Delivering the outcomes you demand

Elevating expectations to reach your higher TAVR standards.

Differentiated outcomes start with differentiated design

The SAPIEN 3 Ultra valve is built on the proven SAPIEN 3 platform to meet the need of today

SAPIEN 3 Ultra valve

SAPIEN 3 Ultra valve

Edwards Commander Delivery System

Predictability and control to meet the increasing complexity of your procedures
Edwards Commander delivery system
*For 20, 23, and 26 mm sizes
†Compared to the Edwards SAPIEN 3 valve

Only SAPIEN 3 TAVR is proven superior to surgery in low-risk patients

SAPIEN 3 TAVR is the only valve proven superior to surgery in low-risk patients while also delivering excellent PVL and pacemaker performance.

On the primary endpoint of death, stroke, and rehospitalization at 1 year. Rehospitalization is defined as valve-related, procedure-related, or heart-failure related.

Primary endpoint: death, stroke, or rehospitalization at 1 year1

Benefits of TAVR
§ More death and stroke events in TAVR patients from 1 to 2 years; no significant differences at 2 years

Mortality and stroke rates superior to surgery

mortality and stroke rate

Excellent PVL performance

Excellent PVL performance

Single-digit new permanent pacemaker rates1

Single-digit new permanent pacemaker rates

Perfecting the pathway

Procedural excellence is setting higher standards with faster procedures, shorter hospital stays, and less rehospitalization.

Procedure times are shorter with SAPIEN 3 TAVR

With fewer complications, you achieve faster procedures, freeing you to help more patients.

Aortic valve replacement (AVR) procedure times

shorter procedure

Your procedural success helps patients get home faster

procedural process
¶ Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients at 30 days

Choosing SAPIEN 3 TAVR can help your patients stay out of the hospital

discharged
#As defined in the PARTNER 3 trial: valve related, procedure related, cardiac related rehospitalization

Controlling for the future

Achieving higher standards for what today’s patients will need tomorrow.

Continuing to meet the emerging needs of new patient populations with SAPIEN 3 Ultra TAVR

Designed for durability

Sapien 3
TAVR with SAPIEN 3 valves proven no different than surgery on7:

Designed to facilitate future coronary access

Coronary access

The SAPIEN 3 Ultra valve allows for future coronary intervention with a low frame height and large cell design.

100% successful post TAVR coronary access

Excellent outcomes in low-risk bicuspid patients

SAPIEN 3 TAVR demonstrated 0% death or disabling stroke and very low rates of mild or greater PVL at 30 days9.
bicuspid

A versatile option for future valve-in-valve procedures

Indicated to treat surgical aortic and mitral valves as well as transcatheter aortic valves for patients at high or greater surgical risk, the SAPIEN 3 Ultra valve can be the preferred option for patients today and in the future.

Valve 2
Valve

Edwards SAPIEN 3 TAVR is built upon:

check

25,000+

patients studied in Edwards THV trials

globe

450,000+

patients treated worldwide with Edwards TAVR valves

Elevating the expectations of what is possible

You asked

We answered

Save lives, starting with the sickest patients

SAPIEN valve

SAPIEN valve

Introducing TAVR as a lifesaving treatment option for patients who are inoperable or at high risk for surgery

Extend lifesaving treatment to even more

SAPIEN XT valve

SAPIEN XT valve

Non-inferior to surgery on mortality and stroke in intermediate-risk patients

Reset the bar to be even better than surgery

SAPIEN 3 valve

SAPIEN 3 valve

The only THV proven superior to surgery for low-risk patients

‡ On the primary endpoint of death, stroke, and rehospitalization at 1 year

Continue to meet the emerging needs of new patient populations

Sapien 3 Ultra valve

SAPIEN 3 Ultra valve

Further reducing PVL and reaching new patients with expanded indications

Welcome to the Higher Standard.
Your standard.

  1. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019;380:1695-1705.
  2. PARTNER II Trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVR with the SAPIEN 3 valve, AT population (n=1077).
  3. Mack MJ. Two-year clinical and echocardiographic outcomes from the PARTNER 3 low-risk randomized trial. Presented at ACC 2020; March 2020; Virtual meeting.
  4. Nazif T, Daniels D, McCabe J, et al. Real-world experience with the SAPIEN 3 Ultra TAVR: A propensity matched analysis from the United States. Presented at: TVT Connect 2020; June 2020; Virtual meeting.
  5. Wood, DA, Lauck SB, Cairns JA, et al. The Vancouver 3M (multidisciplinary, multimodality, but minimalist) clinical pathway facilitates safe next-day discharge home at low-, medium-, and high-volume transfemoral transcatheter aortic valve replacement centers: the 3M TAVR study. JACC Cardiovasc Interv. 2019;12(5):459-469.
  6. Data on file, analysis of 2018 Medicare SAF files.
  7. Kodali S, et al. SAPIEN 3 transcatheter aortic valve replacement compared with surgery in intermediate-risk patients: a propensity matched analysis of 5 year outcomes. Presented at: TVT Connect 2020; June 21, 2020; Virtual meeting.
  8. Tarantini G, Fovino LN, Le Prince P, et al. Coronary access and percutaneous coronary intervention up to 3 years after transcatheter aortic valve implantation with a balloon-expandable valve. Circ Cardiovasc Interv. 2020;13(7):e008972.
  9. The PARTNER 3 Trial, low-risk bicuspid registry, N=71. Edwards Lifesciences data on file.

Important Safety Information

Edwards SAPIEN 3 and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve system

Indications: The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve 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 Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral 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., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications: The valves 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. Incorrect sizing of the valve may lead to paravalvular leak, migration, embolization, residual gradient (patient-prosthesis mismatch), and/or annular rupture. Accelerated deterioration of the valve due to calcific degeneration may occur in children, adolescents, or young adults and in patients with an altered calcium metabolism. Prior to delivery, the valve must remain hydrated at all times and cannot be exposed to solutions other than its shipping storage solution and sterile physiologic rinsing solution. Valve leaflets mishandled or damaged during any part of the procedure will require replacement of the valve. Caution should be exercised in implanting a valve in patients with clinically significant coronary artery disease. Patients with pre-existing bioprostheses should be carefully assessed prior to implantation of the valve to ensure proper valve positioning and deployment. Do not use the valve if the tamper-evident seal is broken, the storage solution does not completely cover the valve, the temperature indicator has been activated, the valve 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 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-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. Valve 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 solution, or to the valve. Balloon valvuloplasty should be avoided in the treatment of failing bioprostheses as this may result in embolization of bioprosthesis material and mechanical disruption of the valve leaflets. Failure to use slow, controlled inflation and prescribed nominal inflation volumes may result in balloon rupture, and lead to patient death or serious injuries associated with difficulty retrieving the delivery system and surgical intervention.

Precautions: Long-term durability has not been established for the valve. Regular medical follow-up is advised to evaluate valve performance. Limited clinical data are available for transcatheter aortic valve replacement in patients with a congenital bicuspid aortic valve who are deemed to be at low surgical risk. Anatomical characteristics should be considered when using the valve in this population. In addition, patient age should be considered as long-term durability of the valve has not been established. 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 Safety Data Sheet available from Edwards Lifesciences. 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. Additional precautions for transseptal replacement of a failed mitral valve bioprosthesis include, the presence of devices or thrombus or other abnormalities in the caval vein precluding safe transvenous femoral access for transseptal approach; and the presence of an Atrial Septal Occluder Device or calcium or abnormalities in the atrial septum preventing safe transseptal access. Special care must be exercised in mitral valve replacement if chordal preservation techniques were used in the primary implantation to avoid entrapment of the subvalvular apparatus. Safety and effectiveness have not been established for patients with the following characteristics/comorbidities: non-calcified aortic annulus; severe ventricular dysfunction with ejection fraction < 20%; congenital unicuspid aortic valve; pre-existing prosthetic ring in any position; severe mitral annular calcification (MAC); severe (> 3+) mitral insufficiency, or Gorlin syndrome; 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; 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; 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; bulky calcified aortic valve leaflets in close proximity to coronary ostia; a concomitant paravalvular leak where the failing bioprosthesis is not securely fixed in the native annulus or is not structurally intact (e.g., wireform frame fracture); or a partially detached leaflet of the failing bioprosthesis that in the aortic position may obstruct a coronary ostium. For Left axillary approach, a left subclavian takeoff angle ~ ≥ 90° from the aortic arch causes sharp angles, which may be responsible for potential sheath kinking, subclavian/axillary dissection and aortic arch damage. Ensure there is flow in Left Internal Mammary Artery (LIMA)/Right Internal Mammary Artery (RIMA) during procedure and monitor PA pressure in homolateral radial artery. Residual mean gradient may be higher in a “THV-in-failing bioprosthesis” configuration than that observed following implantation of the valve inside a native aortic annulus using the same size device. Patients with elevated mean gradient post procedure should be carefully followed. It is important that the manufacturer, model and size of the preexisting bioprosthetic valve be determined, so that the appropriate valve can be implanted and a prosthesis-patient mismatch be avoided. Additionally, pre-procedure imaging modalities must be employed to make as accurate a determination of the inner diameter as possible.

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, atrium, septum, myocardium, or valvular structures that may require intervention; pericardial effusion or cardiac tamponade; thoracic bleeding; 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; arteriovenous (AV) fistula or pseudoaneurysm; reoperation; ischemia or nerve injury or brachial plexus 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; and fever. Additional potential risks associated with the use of the valve, 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; left ventricular outflow tract obstruction; valve deployment in unintended location; 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; and non-emergent reoperation.

Edwards Axela Sheath

Indications: The Edwards Axela sheath is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 Ultra delivery system.

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 are no data to support the sterility, nonpyrogenicity, and functionality of the devices after reprocessing.

Precautions: Caution should be used in vessels that have diameters less than 5.5 mm as it may preclude safe placement of the 14F Edwards Axela sheath. For subclavian/axillary vessels with the 29 mm Edwards SAPIEN 3 Ultra delivery system, caution should be used in vessels that have diameters less than 6.0 mm as it may preclude safe placement of the 14F Edwards Axela sheath. Use caution in tortuous or calcified vessels that would prevent safe entry of the sheath. Do not use the Edwards Axela sheath if the packaging sterile barriers and any components have been opened or damaged or the expiration date has elapsed. When inserting, manipulating or withdrawing a device through the sheath, always maintain sheath position. When puncturing, suturing or incising the tissue near the sheath, use caution to avoid damage to the sheath.

Potential Adverse Events: Complications associated with standard catheterization and use of angiography include, but are not limited to, injury including perforation or dissection of vessels, thrombosis and/or plaque dislodgement which may result in emboli formation, distal vessel obstruction, hemorrhage, infection, and/or death.

Edwards Crimper

Indications: The Edwards crimper is indicated for use in preparing the Edwards SAPIEN 3 Ultra transcatheter heart valve and 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 are 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 THV implantation, refer to the THV Instructions for Use.

Potential Adverse Events: There are no known potential adverse events associated with the Edwards crimper.

CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.

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