See the clinical difference

The PARTNER Trials represent the largest, most rigorous comparative body of evidence in the history of aortic valve replacement, with >10,000 patients studied.

*The PARTNER II Trial intermediate-risk cohort 30-day unadjusted clinical rates for TAVR with the SAPIEN 3 valve, AT population (n=1,077).

Low all-cause mortality and disabling stroke

TAVR with the SAPIEN 3 valve demonstrated 75% lower rates of 30-day all-cause mortality and disabling stroke compared with surgery.

The PARTNER II Trial intermediate-risk cohort unadjusted clinical event rates, AT population.

The valve you trust is now available for more patients

The SAPIEN 3 valve is the only valve approved for valve-in-valve procedures due to failure of a surgical aortic or mitral valve.

Aortic

Mitral

Transformational valve design

Click animation below to play video:

 
PARTNER II Trial intermediate-risk SAPIEN 3 valve cohort (VARC II) versus PARTNER IIA Trial intermediate-risk SAPIEN XT valve cohort (VARC I) 30-day results.
*PARTNER II Trial intermediate-risk SAPIEN 3 valve cohort, core lab assessed paravalvular leak at 30 days, n=1,106
 
 

Complete range of valve sizes and access routes expands the treatable patient population

Video library

*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.
Resources & events

Upcoming events

Oct 29

October 29-November 2 TCT—Denver, CO TCT offers insight on interventional topics and cutting-edge educational content, informative booths, a wide panel of speakers, and discussions on the latest therapies and clinical research. Visit conference website

Nov 11

November 11-15 AHA—Anaheim, CA Experience the leading cardiovascular conference for basic, clinical, and population science in the US. AHA showcases the latest scientific discoveries, keynote speakers, and hands-on learning opportunities. Visit conference website

Dec 8

December 8-12 SCAI Fall Fellows—Las Vegas, NV SCAI Fall Fellows Conference will host an impressive lineup of speakers and educational cases from across the US. SCAI Fall Fellows will challenge and motivate you to focus on saving and enhancing lives. Visit conference website

Jan 27

January 27-31 STS—Fort Lauderdale, FL STS showcases presentations of cardiothoracic specialty areas, including international representations, with abstracts on catheter-based therapy and new technology. Visit conference website

Mar 3

March 3-6 CRT—Washington, DC CRT presents the opportunity to share ideas, collaborate on interventional cardiology solutions, receive interventional cardiology training, and network with other professionals. Visit conference website

Mar 10

March 10-12 ACC—Orlando, FL ACC provides cardiovascular professionals opportunities to stay up to date with the latest advances and practices in heart care and cardiovascular medicine. Visit conference website

Apr 12

April 12-15 CRF Fellows—Orlando, FL Experience lectures, panel discussions of clinical case scenarios and hot topics in interventional cardiology, and interactive angiographic reviews of challenging cases. Visit conference website

Apr 25

April 25–28 SCAI—San Diego, CA SCAI hosts the annual Interventional Cardiology meeting where there will be an impressive lineup of speakers and educational cases from across the US that will challenge and motivate you to focus on saving and enhancing lives. Visit conference website

Apr 28

April 28-May 1 AATS—San Diego, CA Join cardiothoracic surgeons from all over the world to enhance your knowledge and skills across a wide range of subjects including general and specialized cardiac surgery, emerging technologies, congenital heart disease, critical care, and aortic/endovascular surgery. Visit conference website

Jun 17

June 17-20 C3—Orlando, FL The annual Complex Cardiovascular Catheter Therapeutics Conference showcases presentations and debates with expert global faculty, live and prerecorded cases, symposia, booths and simulations, poster sessions, case presentations, and hands-on workshops. Visit conference website

Jun 21

June 21-23 TVT—Chicago, IL Experience the TVT Conference, which will offer a mix of top international faculty, educational live cases, and exciting new ideas across the topics of transcatheter valve repair and replacement. Visit conference website

Sep 5

September 5-9 PICS/AICS—Las Vegas, NV PICS/AICS is a clinically focused conference with sessions on both congenital and structural heart disease, as well as live case demonstrations from around the globe. Visit conference website

Sep 21

September 21-25 TCT- San Diego, CA TCT offers insight on interventional topics and cutting-edge educational content, informative booths, a wide panel of speakers, and discussions on the latest therapies and clinical research. Visit conference website

Important safety information

Edwards SAPIEN 3 transcatheter heart valve with the Edwards COMMANDER and Certitude delivery systems

Important safety information

Edwards SAPIEN 3 transcatheter heart valve with the Edwards COMMANDER and Certitude delivery systems

Indications:

The Edwards SAPIEN 3 transcatheter heart valve (THV), model 9600TFX, and accessories are indicated for patients with symptomatic heart disease due to severe native calcific 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 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 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. 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 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: non-calcified 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 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 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; or bulky calcified aortic valve leaflets 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 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; 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; and 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; 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 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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