6/21/2017
`
`SAPIEN XT transcatheter heart valve | Edwards Lifesciences
`
`SAPIEN XT valve
`
`(/)
`
`Therapies
`
`About Us
`
`Specialty Teams
`
`Devices
`
`Education
`
`Patients
`
`Careers
`
`Investors
`
`Select your region:
`
`United States - English
`
`Product overview
`
`Find a TAVR hospital
`
`Product overview
`
`Edwards SAPIEN XT transcatheter heart valve is approved for delivery with the NovaFlex+ system and Ascendra+ system in 23 mm, 26 mm and 29 mm valve
`sizes.
`
`Balloon-expandable valve design for predictable deployment
`Low proᡃle 16F access
`*
`
`• •
`
`For the 23 mm Edwards SAPIEN XT valve via the transfemoral procedure.
`*
`
`Approved for valve-in-valve procedures
`
`In failed surgical aortic bioprostheses for patients at high or greater surgical risk
`
`Edwards SAPIEN XT valve features
`
`
`Pause
`
`Important safety information
`
`http://www.edwards.com/devices/heart­valves/sapien­xt­valve
`
`1/7
`
`Page 1 of 7
`
`
`

`

`6/21/2017
`
`SAPIEN XT transcatheter heart valve | Edwards Lifesciences
`
`Expanded treatment options
`
`Predictable deployment
`
`Find a TAVR hospital
`
`Enter a ZIP Code, city or state or part of a TAVR hospital name to locate a TAVR hospital near you (US Only).
`
`Important safety information
`
`http://www.edwards.com/devices/heart­valves/sapien­xt­valve
`
`2/7
`
`Page 2 of 7
`
`
`
`
`
`
`

`

`6/21/2017
`
`SAPIEN XT transcatheter heart valve | Edwards Lifesciences
`
`*Enter city and/or state, zip code, or hospital name and select from the list.
`
`  SEARCH 
`
`Important safety information
`
`Edwards SAPIEN XT transcatheter heart valve with the NOVAFLEX+ delivery system
`
`Indications: The Edwards SAPIEN XT transcatheter heart valve is indicated for use in patients with symptomatic heart disease due to either severe native calciᡃc
`aortic stenosis or failure (stenosed, insu᠄cient, or combined) of a surgical bioprosthetic aortic 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., Society of Thoracic Surgeons operative risk score ≥ 8% or at a ≥ 15% risk of mortality 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 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. Care should be exercised when sizing the native annulus or surgical valve; implanting a THV that is too small may
`lead to paravalvular leak, migration or embolization, whereas implanting a THV that is too large may lead to residual gradient (patient-prosthesis mismatch) 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 leaᬄets 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
`signiᡃcant 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 NovaFlex+ 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-ᬄexed 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 ᬄuoroscopic guidance. Some ᬄuoroscopically
`guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful, disᡃguring, 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.
`
`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 ᬄush the a摠ected 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. To maintain proper valve leaᬄet coaptation, do not
`overinᬄate the deployment balloon. Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and
`endocarditis. Safety, e摠ectiveness, and durability have not been established for THV in THV procedures.  Safety and e摠ectiveness have not been established for
`patients with the following characteristics/comorbidities: non-calciᡃed 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 ring in any position, severe mitral annular calciᡃcation (MAC), severe (> 3+) mitral insu᠄ciency, or Gorlin syndrome, blood dyscrasias deᡃned
`Important safety information
`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
`
`http://www.edwards.com/devices/heart­valves/sapien­xt­valve
`
`3/7
`
`Page 3 of 7
`
`
`
`

`

`6/21/2017
`
`SAPIEN XT transcatheter heart valve | Edwards Lifesciences
`
`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, signiᡃcant aortic disease, including abdominal aortic or thoracic aneurysm deᡃned 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 calciᡃcation 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 16F, 18F, or 20F Edwards expandable introducer sheath set, such as severe obstructive calciᡃcation, severe tortuosity or diameter less than 6 mm,
`6.5 mm, or 7 mm, respectively, bulky calciᡃed aortic valve leaᬄets in close proximity to coronary ostia, a concomitant paravalvular leak where the surgical
`bioprosthesis is not securely ᡃxed in the native annulus or is not structurally intact (e.g. wireform frame fracture), and a partially detached leaᬄet of the surgical
`bioprosthesis that in the aortic position may obstruct a coronary ostium.  The safety and e摠ectiveness have not been established for implanting the THV inside a
`stented bioprosthetic valve < 21 mm (labeled size) or an unstented bioprosthetic aortic valve.  Residual mean gradient may be higher in a “TAV-in-SAV”
`conᡃguration than that observed following implantation of the THV 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 surgical bioprosthetic aortic valve be
`determined, so that the appropriate THV 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 internal oriᡃce 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 deᡃcit; paralysis; permanent disability; respiratory insu᠄ciency 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 e摠usion or cardiac tamponade; embolization including air, calciᡃc valve material or thrombus; infection including septicemia and endocarditis; heart
`failure; myocardial infarction; renal insu᠄ciency or renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia;
`retroperitoneal bleed; AV ᡃstula or pseudoaneurysm; reoperation; ischemia or nerve injury; restenosis; pulmonary edema; pleural e摠usion; 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; inᬄammation; 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 ᬄow obstruction/transvalvular ᬄow 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,
`calciᡃcation, leaᬄet tear/tearing from the stent posts, leaᬄet 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.
`
`Edwards expandable introducer sheath set
`
`Indications: The Edwards expandable introducer sheath is indicated for the introduction and removal of devices used with the Edwards SAPIEN XT transcatheter
`heart valve.
`
`Contraindications: This product is contraindicated for tortuous or calciᡃed vessels that would prevent safe entry of the introducer and sheath.
`
`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 expandable introducer sheath set must be used with a compatible
`0.035” guidewire.
`
`Precautions: Do not use the introducer sheath set if the packaging sterile barriers and any components have been opened or damaged. The Edwards Expandable
`Sheath temporarily enlarges to allow the passage of devices; ensure that the vasculature can accommodate the maximum diameter of the expanded sheath. When
`inserting, manipulating or withdrawing a device through the expandable 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, stroke, infection,
`and/or death.
`
`Edwards SAPIEN XT transcatheter heart valve with the ASCENDRA+ delivery system
`
`Indications: The Edwards SAPIEN XT transcatheter heart valve is indicated for use in patients with symptomatic heart disease due to either severe native calciᡃc
`aortic stenosis or failure (stenosed, insu᠄cient, or combined) of a surgical bioprosthetic aortic 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., Society of Thoracic Surgeons operative risk score ≥ 8% or at a ≥ 15% risk of mortality 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 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. Care should be exercised when sizing the native annulus or surgical valve; implanting a THV that is too small may
`lead to paravalvular leak, migration or embolization, whereas implanting a THV that is too large may lead to residual gradient (patient-prosthesis mismatch) or
`Important safety information
`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 leaᬄets mishandled or
`
`http://www.edwards.com/devices/heart­valves/sapien­xt­valve
`
`4/7
`
`Page 4 of 7
`
`
`

`

`6/21/2017
`
`SAPIEN XT transcatheter heart valve | Edwards Lifesciences
`
`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
`signiᡃcant 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. Patients presenting with combination AV low ᬄow, low gradient should undergo additional evaluation to establish the degree of
`aortic stenosis. 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 Ascendra+ 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. 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 ᬄuoroscopic guidance. Some ᬄuoroscopically guided procedures are associated with a risk of radiation injury to the skin. These injuries may be painful,
`disᡃguring, 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.
`
`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 ᬄush the a摠ected 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. To maintain proper valve leaᬄet coaptation, do not
`overinᬄate the deployment balloon. Appropriate antibiotic prophylaxis is recommended post-procedure in patients at risk for prosthetic valve infection and
`endocarditis. Safety, e摠ectiveness, and durability have not been established for THV in THV procedures. Safety and e摠ectiveness have not been established for
`patients with the following characteristics/comorbidities: Non-calciᡃed 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 ring in any position, severe mitral annular calciᡃcation (MAC), severe (> 3+) mitral insu᠄ciency, or Gorlin syndrome, blood dyscrasias deᡃned
`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, excessive calciᡃcation of vessel at access site, bulky calciᡃed aortic valve leaᬄets in close proximity to coronary ostia, a concomitant
`paravalvular leak where the surgical bioprosthesis is not securely ᡃxed in the native annulus or is not structurally intact (e.g. wireform frame fracture), and a
`partially detached leaᬄet of the surgical bioprosthesis that in the aortic position may obstruct a coronary ostium.  The safety and e摠ectiveness have not been
`established for implanting the THV inside a stented bioprosthetic valve < 21 mm (labeled size) or an unstented bioprosthetic aortic valve.  Residual mean gradient
`may be higher in a “TAV-in-SAV” conᡃguration than that observed following implantation of the THV 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
`surgical bioprosthetic aortic valve be determined, so that the appropriate THV 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 internal oriᡃce 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 deᡃcit; paralysis; permanent disability; respiratory insu᠄ciency 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 e摠usion or cardiac tamponade; embolization including air, calciᡃc valve material or thrombus; infection including septicemia and endocarditis; heart
`failure; myocardial infarction; renal insu᠄ciency or renal failure; conduction system defect which may require a permanent pacemaker; arrhythmia;
`retroperitoneal bleed; AV ᡃstula or pseudoaneurysm; reoperation; ischemia or nerve injury; restenosis; pulmonary edema; pleural e摠usion; 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; inᬄammation; 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 ᬄow obstruction/transvalvular ᬄow 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,
`calciᡃcation, leaᬄet tear/tearing from the stent posts, leaᬄet 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.
`
`ASCENDRA+ introducer sheath set
`
`Indications: The Ascendra+ introducer sheath set is indicated for the introduction and removal of devices used with the Edwards SAPIEN XT transcatheter heart
`valve.
`
`Contraindications: 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. Do not mishandle the device 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. Should not be used in patients with left ventricular
`aneurysm. The Ascendra+ introducer sheath set must be used with a 0.035” guidewire.
`
`Precautions: No known precautions.
`
`Potential adverse events: Complications associated with cardiac surgical intervention and use of angiography include, but are not limited to, allergic reaction to
`anesthesia or to contrast media, injury including myocardial injury, thrombus formation, and plaque dislodgement which may result in myocardial infarction,
`arrhythmia, stroke, and/or death. Reference the Edwards SAPIEN XT transcatheter heart valve with the Ascendra+ delivery system Instructions for Use for a full
`list of potential adverse events.
`
`Important safety information
`Edwards crimper
`
`http://www.edwards.com/devices/heart­valves/sapien­xt­valve
`
`5/7
`
`Page 5 of 7
`
`
`

`

`6/21/2017
`
`SAPIEN XT transcatheter heart valve | Edwards Lifesciences
`
`Indications: The Edwards crimper is indicated for use in preparing the Edwards SAPIEN XT transcatheter heart valve for implantation.
`
`Contraindications: No known contraindications.
`
`Warnings: The device is designed, intended, and distributed for single use only. Do not resterilize or reuse the device. There are no data to support the sterility,
`nonpyrogenicity, and functionality of the device after reprocessing. Do not mishandle the device. Do not use the device if the packaging or any components are
`not sterile, have been opened or are damaged, or the expiration date has elapsed.
`
`Precautions: For special considerations associated with the use of this device prior to THV implantation, refer to the SAPIEN XT transcatheter heart valve
`Instructions for Use.
`
`Potential adverse events: No known potential adverse events.
`
`Search Edwards.com
`
`Follow Edwards on:
`
`
`
`
`
`
`
`
`
`
`
`
`(https://www.facebook.com/EdwardsGiving)(https://twitter.com/edwardslifesci)(https://www.linkedin.com/company/edwards-(https://www.youtube.com/user/EdwardsGlobal)
`About us (/aboutus/home)
`lifesciences)
`Careers (/careers/home)
`Investors (http://ir.edwards.com)
`MRI safety (/mri-safety)
`Contact us (/aboutus/contactus)
`Ecommerce (/aboutus/ecommerce)
`Site map (/sitemap)
`Legal terms (/legal/legalterms)
`Privacy policy (/legal/privacypolicy)
`
`© 2017 Edwards Lifesciences Corporation.
`All rights reserved.
`
`(/)
`
`Important safety information
`
`http://www.edwards.com/devices/heart­valves/sapien­xt­valve
`
`6/7
`
`Page 6 of 7
`
`
`
`
`
`
`
`

`

`6/21/2017
`
`SAPIEN XT transcatheter heart valve | Edwards Lifesciences
`
`http://www.edwards.com/devices/heart­valves/sapien­xt­valve
`
`7/7
`
`Page 7 of 7
`
`