Frequently Asked Questions

You or your patient may have questions about diagnosis, symptoms, and treatment options for aortic stenosis.

Use the most commonly asked questions below as a conversation guide with your patient or a resource for your practice.

See below the most common questions general cardiologists have about TAVR.

How do I know if TAVR is right for my patient?
TAVR used to only be available for patients too frail to undergo open heart surgery. Now, the procedure is available to a wider cohort of patients depending on their risk for open heart surgery. A multidisciplinary TAVR team at a TAVR hospital will determine if TAVR is the right treatment plan.1,2
How will TAVR benefit my patient’s quality of life?
Research has shown that patients who undergo the less invasive TAVR procedure have improved health within 30 days of their procedure. Within 12 months of TAVR, patients experience significant improvement in performing daily activities (working, showering, walking).3,4
What is the durability of a TAVR valve?
While the durability varies with each patient, transcatheter heart valves show robust durability data with less than 1% reintervention rates for structural valve deterioration through 5 years.5
How can I find a TAVR hospital near me?
You can search for a TAVR hospital and view details about each listing here.
What if my hospital or TAVR Team cannot accept any more patients (ie, they're at full capacity)?
Don't wait to refer for an evaluation. If the nearest TAVR Hospital is at full capacity, check other TAVR Hospitals for availability.

References: 1. Nishimura R, Otto C, Bonow R, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary. J Am Coll Cardiol. 2017;135(25):e1159-e1195. 2. Nishimura R, Otto C, Bonow R, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary. J Am Coll Cardiol. 2014;63(22):2438-2488. 3. Arnold SV, Spertus JA, Vemulapalli S, et al. Quality-of-life outcomes after transcatheter aortic valve replacement in an unselected population: a report from the STS/ACC Transcatheter Valve Therapy Registry. JAMA Cardiol. 2017;2(4):409-416. 4. Baron S, Thourani V, Kodali S, et al. Effect of SAPIEN-3 transcatheter valve implant on health status in patients with severe aortic stenosis at intermediate surgical risk: results from the partner s3i trial. JACC Cardiovasc Interv. 2018;11(12):1188-1198. 5. Douglas PS, Leon MB, Mack MJ, et al. Longitudinal hemodynamics of transcatheter and surgical aortic valves in the PARTNER trial. JAMA Cardiol. 2017;2(11):1197-1206.

See below the most common questions patients have about aortic stenosis and TAVR.

About Aortic Stenosis

What is aortic stenosis?
Aortic stenosis is a progressive condition caused by a narrowing of the aortic valve, which prevents normal blood flow. Because the condition will get worse with time, doctors will measure it as mild, moderate, or severe (depending on how damaged the valve is). The condition affects more than 2.5 million people over the age of 75 in the United States.1,2
What causes aortic stenosis?
There are four main causes of aortic stenosis: calcium build-up on the valve leaflets, birth defects that may impact the structure of the aortic valve, rheumatic fever which can cause scar tissue to form in the heart, and radiation therapy.
What is severe aortic stenosis?
If aortic stenosis goes untreated, it will progress to the severe stages of the disease. Severe aortic stenosis means the aortic valve has a severe build-up of calcium and has a difficult time opening and closing. Your heart may need to work harder to pump blood throughout your body.
What is severe symptomatic aortic stenosis?
Once aortic stenosis progresses to the severe stages, symptoms such as shortness of breath, chest pain, fatigue, or lightheadedness may occur. It is important to tell your doctor right away if you experience symptoms or if your symptoms worsen.3
What are the symptoms of severe aortic stenosis?
Symptoms of severe aortic stenosis include shortness of breath, chest pain, fatigue, lightheadedness, rapid or irregular heartbeat, swollen ankles/feet or difficulty exercising.3 These symptoms may indicate your aortic stenosis has progressed to a life-threatening point.
How serious is severe aortic stenosis (also known as severe aortic valve stenosis)?
Approximately 50 percent of people who develop severe aortic stenosis symptoms will die within an average of two years if they do not have their aortic valve replaced.4 If you have been diagnosed with severe aortic stenosis and have symptoms, talk to your doctor right away about your treatment options.

Diagnosis and Treatment of Aortic Stenosis

How is aortic stenosis diagnosed?
Your doctor will perform a few tests to determine if you have aortic stenosis. This is primarily done by listening to the sounds of your heart with a stethoscope. Diagnosis may also be done through a test called echocardiogram, which uses ultrasound waves to obtain images of the heart chambers and valves.
What are the treatment options for aortic stenosis?
Depending on how far your aortic stenosis has progressed, your doctor may prescribe medication to help control your symptoms. However, it’s important to know the only effective way to treat aortic stenosis is by replacing your valve. This can be done through transcatheter aortic valve replacement (TAVR) or open heart surgery.

About Transcatheter Aortic Valve Replacement (TAVR)

What is TAVR (transcatheter aortic valve replacement)?
TAVR (also known as transcatheter aortic valve implantation or TAVI for short) is a less invasive procedure for replacing a diseased aortic valve. During the procedure, your TAVR Doctor will use a catheter to implant a new valve within your diseased valve. TAVR can be performed through multiple approaches, however, the most common is through a small incision in the leg.
What are the different approaches used to perform TAVR?
TAVR allows for a variety of access points, depending on patient anatomy, including: transfemoral, subclavian, transaortic, transapical, and others. The transfemoral approach is the most common.
How could I benefit from a transcatheter valve replacement?
With the less invasive TAVR procedure, people may return to daily activities sooner than with open heart surgery. People who undergo TAVR report improved quality of life following the procedure. Other TAVR benefits include: short hospital stay, relief of symptoms (sometimes immediately), improved heart function, and reduced pain and anxiety.5-8
How long is the TAVR procedure?
Depending on your health and the procedural approach recommended by your doctor, the average TAVR procedure lasts approximately 1.5 hours. In comparison, the average open heart surgery lasts approximately 4 hours.
How long does a transcatheter heart valve last?
How long your transcatheter heart valve will last depends on many factors and will vary per person. However, regular follow-ups will help your doctor know how your valve is working.
What is TAVI, and is it different from TAVR?
TAVI stands for transcatheter aortic valve implantation. The procedure and its approaches are the same as TAVR. Your doctor may use the terms interchangeably when discussing your treatment options.
How long have TAVR procedures been performed?
TAVR has been commercially available in Europe since 2007 and in the United States since 2011.
Are there different types of transcatheter heart valves and can I ask for a specific valve?
Transcatheter heart valves are made by different manufacturers. You can check which valves are used and available at your hospital. Although you can ask for a specific valve, your TAVR Doctor will recommend the best valve for you. Learn More About Edwards Transcatheter Heart Valves
Does my insurance cover TAVR and do I need a referral?
You should contact your insurance carrier directly prior to your first appointment with your TAVR Doctor to determine if your TAVR evaluation and TAVR procedure are covered, and if a referral is required. The Centers for Medicare and Medicaid Services (CMS) cover TAVR under certain conditions. You can learn more by visiting our Helpful Websites page. Learn More on Our Helpful Websites Page

Getting a TAVR Evaluation

How do I know if TAVR is right for me?
TAVR used to only be available for people who were too weak to undergo open heart surgery. But now, the procedure is available to more people depending on their risk for open heart surgery. It is also an option for people who previously had their aortic and/or mitral valve replaced. You need to consult an interventional cardiologist at a TAVR hospital to determine if TAVR is an option for you. You can use our Find a TAVR Hospital tool to identify the nearest location to you.
What tests will my doctor perform to determine if TAVR is right for me?
Your doctor may use one or more of these tests to determine if TAVR is the best option for you.
  • Chest X-ray: A type of imaging to view images of the organs and structures inside your chest. You will be placed between a metal plate and the x-ray machine. The x-ray technician will take several images of your chest in a variety of positions. This may take up to 30 minutes to perform.
  • Transthoracic echochardiogram (TTE): This diagnostic test (also known as an echo) uses ultrasound to obtain 3D images of the heart. While you are lying on a table, a probe will be placed on your chest wall and will use sound waves to provide detailed pictures of your heart. This usually takes 30-60 minutes.
  • Magnetic resonance imaging (MRI): A diagnostic test that uses magnetic and radio waves to take detailed pictures of your heart. You will be asked to lie down on a bed that moves into a large tube. You won’t feel anything but will hear a noise as the images are acquired. You will be asked to lie very still for duration of test. This usually takes 30-90 minutes.
  • Pulmonary function test (PFT): A group of tests, using special breathing equipment, that will measure how well your lungs are moving oxygen to the blood. These can take 60-120 minutes.
  • Computerized tomography (CT) scan: An imaging test that uses x-rays to obtain detailed pictures of your heart and blood vessels. You will be injected with contrast dye through an IV. You will be asked to lie down on a bed that passes through a donut-shaped x-ray scanner to take clear images of your heart. This takes up to 60 minutes.
  • Angiogram (cardiac cath): An imaging test that uses x-ray and dye to see how blood flows through your arteries and veins. You will lie on your back on an x-ray table. A small incision will be made and a small tube, called a catheter, will be inserted either in your groin or near your elbow. Dye will be injected into the vessel to make the area show clearly on the x-ray pictures. This takes up to 60 minutes.
  • Transesophageal echocardiogram: A test that obtains detailed pictures of your heart by inserting a probe down the esophagus (throat). While lying on a table, a technician will spray your throat with medicine to numb and suppress your gag reflex. A thin flexible tube will be guided down your throat. The probe will send and receive sound waves which will become pictures on a video screen. This may take up to 60 minutes.
How can I get evaluated for TAVR?
To see if the TAVR procedure is right for you, you need to seek out expert care from a specialized heart doctor called an interventional cardiologist at a TAVR Hospital. Only a TAVR hospital can evaluate you for both TAVR and open heart surgery to determine what the best treatment option is for you. Not all hospitals perform TAVR, but you can find the nearest TAVR hospital using the Find a TAVR Hospital Tool.
What is a Heart Team?
You may have heard the term Heart Team while researching your aortic stenosis treatment options. A Heart Team is a specialized care team that includes interventional cardiologists, cardiothoracic surgeons, imaging specialists, anesthesiologists, cardiac cath lab staff, and a cardiologist. Together, the specialized Heart Team will conduct a comprehensive evaluation to determine whether the TAVR procedure is appropriate for you.
What if my doctor doesn’t know about TAVR or perform TAVR?
If your doctor doesn’t perform TAVR, you should ask for a referral to a TAVR Hospital. The doctors at a TAVR Hospital are experts in valvular disease and valve replacement and are able to determine the best treatment option for you. Find the nearest TAVR Hospital
What if my doctor does not think I am a good candidate for TAVR?
If your doctor does not think you are a good candidate for TAVR, you may still contact a TAVR Hospital to receive a second opinion. Find a TAVR Hopsital

Recovery from TAVR

What should I expect directly after my TAVR procedure?
Typically following a TAVR procedure, you may be taken to the intensive care unit (ICU) for a little while or moved directly to a recovery room. Your doctor will update your caregiver or loved ones on how you are doing.
What does life after TAVR look like?
Research has shown that patients that undergo the less invasive TAVR procedure have improved health within 30 days of their procedure. To optimize your recovery, your doctor will give you specific instructions, which may include a special diet, exercise, and medication therapy. It is important to carefully follow your doctor’s directions, especially if blood-thinning drugs are prescribed.

Patient Resources for Aortic Stenosis and TAVR

Are there resources available to better understand aortic stenosis and treatment options?
There are many free patient resources available to learn more about aortic stenosis and TAVR, including patient stories, TAVR brochures and procedure videos. A personalized information kit is also available to help answer your questions on aortic stenosis and TAVR.
How can I connect with other patients like me to learn about their TAVR journey?

You can get connected with others who have gone through TAVR and ask them questions and hear their stories through the Edwards PatientConnect program. Simply call our toll-free number (1-877-209-8638) or fill out the Edwards PatientConnect program form and a dedicated team member will reach out to help you get started.

Get Support
Are there support groups or other helpful websites I can visit for more information?
There are a variety of helpful websites that may provide additional information on diagnosis and treatment of aortic stenosis as well as support services. Visit our helpful websites page to learn about these available resources. Learn More on Our Helpful Websites Page
How can I find a TAVR hospital near me?
You can search for TAVR hospitals by zip code, city/state, or by hospital name using our Find a TAVR Hospital tool. Once you find a TAVR hospital near you, you may click on the provider to view listing details. Find a TAVR Hospital

References: 1. US Census Bureau, 2013-2017 5-Year American Community Survey. American FactFinder website. https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=bkmk. Accessed April 17, 2019. 2. Osnabrugge RL, Mylotte D, Head SJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013;62(11):1002-1012. 3. Aortic Valve Stenosis. Mayo Clinic website. www.mayoclinic.org/diseases-conditions/aortic-stenosis/symptoms-causes/syc-20353139. Published March 9, 2018. Accessed February 7, 2019. 4. Ross J Jr, Braunwald E. Aortic stenosis. Circulation. 1968;38:61–67. 5. Kleczyński P, Bagieński M, Sorysz D, et al. Short- and intermediate-term improvement of patient quality of life after transcatheter aortic valve implantation: a single-centre study. Kardiol Pol. 2014;72:612–616. 6. Arnold SV, Spertus JA, Vemulapalli S, et al. Quality-of-life outcomes after transcatheter aortic valve replacement in an unselected population: A report From the STS/ACC Transcatheter Valve Therapy Registry. JAMA Cardiol. 2017;2(4):409–416. 7. Minutello RM, Wong SC, Swaminathan RV, et al. Costs and in-hospital outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement in commercial cases using a propensity score matched model. Am J Cardiol. 2015;115:1443–1447. 8. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2016;374:1609–1620.

Important Safety Information

Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System

Indications: The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System 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 appropriate for the transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or 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 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: Safety, effectiveness, and durability have not been established for THV-in-THV procedures. Long-term durability has not been established for the valve. Regular medical follow-up is advised to evaluate valve 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 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; congenital bicuspid aortic valve in low surgical risk patients; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+); 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; access characteristics that would preclude safe placement of the 14F or 16F Edwards eSheath introducer set or the 14F Axela sheath, such as severe obstructive calcification, severe tortuosity, or diameter less than 5.5 mm (14F Axela or 14F eSheath introducer set) or 6 mm (16F eSheath introducer set or 14F Axela in subclavian access); excessive calcification at access site; 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. 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; 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; 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; injury to the mitral valve; device explants; mediastinitis; mediastinal bleeding; 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 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 eSheath

Indications: The Edwards eSheath introducer set is indicated for the introduction and removal of devices used with the Edwards SAPIEN 3 and the SAPIEN 3 Ultra transcatheter heart valves.

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. The Edwards eSheath introducer set must be used with a compatible 0.035” (0.89 mm) guidewire to prevent vessel injury.

Precautions: Caution should be used in vessels that have diameters less than 5.5 mm or 6 mm as it may preclude safe placement of the 14F and 16F Edwards eSheath introducer set respectively. Use caution in tortuous or calcified vessels that would prevent safe entry of the introducer set. Do not use the Edwards eSheath introducer set if the packaging sterile barriers and any components have been opened or damaged. 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.

Find a TAVR Team