Please talk to your doctor to decide whether this therapy is right for you. Selecione a sua regio. `)\;>! CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI During the procedure, monitor contrast media usage. Update my browser now. Antibiotics maybe recommendedfor patients who are at risk of infections. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. United States of America * Country / Region. January 2016;102(2):107-113. Keep appointments with your doctor. 2020 Medtronic. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Less information (see less). Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. You may also call800-961-9055 for a copy of a manual. Cardiovascular Proper sizing of the devices is the responsibility of the physician. endstream endobj startxref From CoreValve to Evolut PRO: Reviewing the Journey of Self - PubMed Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: With an updated browser, you will have a better Medtronic website experience. Indications, Safety, & Warnings. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system. Damage may result from forceful handling of the catheter. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). See how the external tissue wrap on the Evolut PRO TAVI performs. THE List - MRI Safety For best results, use Adobe Acrobat Reader with the browser. In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure. Medtronic Launches Head-to-Head TAVR Study Comparing the Corevalve Find more detailed TAVRinformation, educationalresources, and tools. THE List - MRI Safety Home If you continue, you may go to a site run by someone else. See how the external tissue wrap on the Evolut PRO TAV performs. Update my browser now. Broadest annulus range based onCT-derived diameters. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Medtronic MRI Resource Library Technical Information for Healthcare Professionals. Update my browser now. T`2r@P~[HX$AQ]Iq7S!3]j&3\@&~)k 1*rLF~- D5@6H00 n9@ s Or, you may contact technical support online. Search by the product name (e.g., Evolut) or model number. Transcatheter Aortic Heart Valves | Medtronic The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. Products These legacy and new design features provide the following sealing mechanisms: The Evolut TAVI platform demonstrates EOAs that are consistently large and may have a benefit for healthier, more active patients. For best results, use Adobe Acrobat Reader with the browser. EVOLUT PRO+ SYSTEM Transcatheter Aortic Valve Implantation (TAVI) The next generation Evolut TM PRO+ transcatheter aortic valve system provides industry-leading hemodynamics allowing your patients to return to activity faster. Products 2020 Medtronic. Click OK to confirm you are a Healthcare Professional. The Evolut TAVR platform, including the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems, is indicated for symptomatic patients with severe aortic stenosis across all surgical risk categories (extreme, high, intermediate and low) in the U.S. and countries that recognize CE Mark. Not doing so could result in injury or death. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. Products Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. Update my browser now. Safety Info ID# Safety Topic / Subject Article Text 179: . Learn how the Evolut platform isdesigned to go beyond proceduraloutcomes to benefit your patients. Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. The external wrap increases surface contact with native anatomy, providing advanced sealing. With an updated browser, you will have a better Medtronic website experience. Allows access down to5.0 mm vessels with2329 mm valves. The SMall Annuli Randomized To Evolut or Sapien (SMART) post-market trial will compare valve safety and performance of the self-expanding Medtronic CoreValve Evolut Pro and Pro . You may also call 800-961-9055for a copy of a manual. Indications, Safety, and Warnings Product Details The Evolut PRO valve features an external tissue wrap added to the proven platform design. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. Home Healthcare Professionals Flameng, W, et al. More information (see more) Heart Valves and Annuloplasty Rings More. English. Reach out to LifeLine CardioVascular Tech Support with questions. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Complications at the area where the doctor cutthe skin or related to cutting the skin, includingbut not limited to: Hematoma blood collecting under the skin, Pseudoaneurysm blood collecting on theoutside of a vessel wall causing a balloon-likewidening, Irreversible nerve damage permanentdamage to nerves, Compartment syndrome squeezing ofnerves and muscles in a closed space thatcould cause muscle or nerve damage, Stenosis narrowing of a blood vessel(artery), Mitral valve regurgitation blood leakingbackward through the valve between the leftlower chamber of the heart to the left upperchamber of the heart, Hypotension or hypertension low or highblood pressure, Bowel ischemia decreased blood supply tothe intestines. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. The safety and effectiveness of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a failed preexisting transcatheter bioprosthesis have not been demonstrated. Healthcare Professionals Your doctor can let you know which risks will most likely apply to you. The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems 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. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. November 1, 1999;34(5):1609-1617. 2010; 121:2123-2129. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. Re-engineered delivery system expands flexibility for360 range of motion and increases conformability to the anatomy for a 50% reduction in tracking forces*1 in challenging anatomies. Treatments & Therapies 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. What is Evolut pro valve made of? - Studybuff Access instructions for use and other technical manuals in the Medtronic Manual Library. Healthcare Professionals Search by the product name (e.g., Evolut) or model number. The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Anatomical characteristics should be considered when using the valve in this population. Dysfunctions of a Medtronic TAVR valve,including but not limited to: Valve frame does not open (expand) allthe way, Pannus the formation of scar tissuethat may cover or block the valve fromfunctioning normally, Wear, tear, or movement forward (prolapse)or backward (retraction) from the normalposition of the valve leaflets, A break in the stitches (sutures) of the valveframe or leaflets, Leakage through or around the valve orvalve frame, Incorrect position of the valve, either toohigh or too low, Regurgitation backward flow of bloodthrough the valve, Stenosis narrowing of the opening ofthe valve, Valve migration upward or downwardmovement of the device from where itwasoriginally placed, Embolism an abnormal particle (air, bloodclots) floating in the blood stream or attachedto an object, including the valve or deliverysystem component, Infection of the heart, blood, or other areas, Thrombosis (including valve thrombosis) blood clot, including a blood clot on the valve, Individual or multi-organ insufficiency or failure. Expect more surface contact between the valve andthe native aortic annulus, with an external tissue wrap for all valve sizes. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. How long it lasts varies from patient to patient. The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. Pibarot P, Dumesnil JG. %%EOF Recapture and reposition Warnings:Younger patients, or patients with a diseasethat results in more calcium in their blood,may have early wear of their valve. Transcatheter Aortic Heart Valves - Cardiovascular | Medtronic 0 The bioprosthesis size must be appropriate to fit the patients anatomy. Less information (see less). J Am Coll Cardiol. Home Unfavorable reaction by the body (allergicreaction) to: Antiplatelet agents blood-thinningmedicines that keep blood clots from forming, Contrast medium a substance used toincrease the visualization of body structuressuch as X-ray dye. Home Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Products A number of factors determine a patients risk, including age and other medical conditionsthat make surgery more dangerous.
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