Patients who have already had a valve replaced should be carefully assessed by their physician prior to receiving a new valve to ensure proper placement of the new valve. © 2020 Edwards Lifesciences Corporation. The long-term durability of the Edwards SAPIEN XT transcatheter heart valve is not known, at this time. Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly. Transcatheter aortic heart valve patients should take medications that thin the blood or prevent blood clots from forming, except when likely to have an adverse reaction, as determined by their physician. Treating your severe aortic stenosis is an important step toward a healthier heart and improved quality of life, but for some, it can be a lot to take in. X-ray guidance used during the procedure may cause injury to the skin, which may be painful, damaging, and long-lasting. Our Edwards PatientConnect team is here for you. Allergies to blood-thinning medications or dye injected during the procedure. FloTrac eLearning courses ev1000 btn-eLearning. Physiologic Implications of Appropriate Volume Administration. Dive Brief: Edwards Lifesciences raised expectations for 2020 transcatheter aortic valve replacement (TAVR) sales in a report to investors Thursday after seeing demand rebound faster than expected amid disruptions from COVID-19. Previous heart valve replacement or repair, A heart that does not pump well, has thickening of the heart muscle, with or without blockage, unusual ultrasound images of the heart that could represent irregularities such as a blood clot, a diseased mitral valve that is calcified or leaking, or Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing various cancers and tumors, Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly, Diseased or irregularly shaped vessels leading to the heart. Risks involving bleeding or your blood supply, including formation of a blood clot, high or low blood pressure, limited blood supply, a decrease in red blood cells, or abnormal lab values, bleeding in the abdominal cavity, collection of blood under the skin. FloTrac sensor on EV1000 monitor Product Mastery Sign in here to gain access to your personal learning portal. Vessels which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry. Previous heart valve replacement or repair, A heart that does not pump well, has thickening of the heart muscle, with or without blockage, unusual ultrasound images of the heart that could represent irregularities such as a blood clot, a diseased mitral valve that is calcified or leaking, or Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing various cancers and tumors, Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly, Diseased or irregularly shaped vessels leading to the heart. An aortic heart valve that is not calcified, contains only one leaflet, two leaflets in low surgical risk patients, has leaflets with large pieces of calcium that may block the vessels that supply blood to the heart or in which the main problem is that the valve leaks. Have an active infection in the heart or elsewhere. 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Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. We’re here to help and we can even connect you with others who have received transcatheter aortic valve replacement (TAVR) and know what you are going through. Previous prosthetic ring in any position. The Acumen IQ sensor connects to any existing radial arterial line and provides advanced hemodynamic parameters that offer continuous insight into your patient's hemodynamic status. Edwards EV1000 Clinical Platform elearning courses FREE. Vessels which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry. Edwards TAVR is the only FDA approved valve that has been proven superior to surgery. A pocket card summarizing normal hemodynamic and laboratory values. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Indications: Transcatheter heart valve patients should talk to their physicians about the potential need for medications that thin the blood or prevent blood clots from forming. Patients who have already had a valve replaced should be carefully assessed by their physician prior to receiving a new valve to ensure proper placement of the new valve. Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are sensitive to cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or polymeric materials. Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery and possible removal of the SAPIEN 3 Ultra or SAPIEN 3 valves, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), nonstructural valve dysfunction (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue in growth, blood cell damage, etc.) We’re here to help and we can even connect you with others who have received transcatheter aortic valve replacement (TAVR) and know what you are going through. or mechanical failure of the delivery system and/or accessories. The most serious risks of TAVR include death, stroke, serious bleeding, and serious damage to the arteries. During the transfemoral procedure, your doctors should monitor the dye used in the body; if used in excess it could lead to kidney damage.

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