- (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Home During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Cardiovascular It is possible that some of the products on the other site are not approved in your region or country. Manuals can be viewed using a current version of any major internet browser. Update my browser now. The Evolut PRO valve features an external tissue wrap added to the proven platform design. The Evolut PRO+ system is indicated to treat annulus ranges up to 30 mm in diameter and hasthe ability to treat the broadest annulus range* of any commercially available TAVR system. Third attempt must be a complete recapture and retrieval from patient. Search by the product name (e.g., Evolut) or model number. Products 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. 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. 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. This study is a prospective, single arm, multi-center . GeneralImplantation of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems should be performed only by physicians who have received Medtronic CoreValve Evolut R, Evolut PRO+, or Evolut FX training. Home What is a Medtronic valve? PDF Summary of Safety and Effectiveness Data I. General Information endstream endobj startxref Medtronic Evolut TAVR System Shows Strong Performance at Two Years in Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. It is possible that some of the products on the other site are not approved in your region or country. The Medtronic TAVR valve hasbeen testedin the laboratory to mimic five years of typical use without failure. Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus. Heart Valves and Annuloplasty Rings More. Pibarot P, Dumesnil JG. Transcatheter Aortic Heart Valves - Evolut PRO | Medtronic During the procedure, monitor contrast media usage. January 2016;102(2):107-113. Warnings:Younger patients, or patients with a diseasethat results in more calcium in their blood,may have early wear of their valve. 2010; 121:2123-2129. - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. Evolut PRO+ - Transcatheter Aortic Heart Valves | Medtronic Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. cy[7Ju)z|~{B3% ^!pE~(u|@x9;D9DYY(bC4|fffn\W4Lr[QFX Evolut PRO+ Transcatheter Aortic Valve | Medtronic Broadest annulus range* Medtronic MRI Resource Library: Home This procedure should only be performed where emergency aortic valve surgery can be performed promptly. endstream endobj 4545 0 obj <. Healthcare Professionals Click OK to confirm you are a Healthcare Professional. Pibarot P, Dumesnil JG. Flameng, W, et al. Bleiziffer S, Eichinger WB, Hettich I, et al. (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5, l@ !W Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Transcatheter aortic valve replacement (TAVR), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Transcatheter Aortic Valve Replacement (TAVR), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, Cardiogenic shock failure of the heart topump enough blood to the body organs, Cardiac tamponade the constriction orinability of the heart to pump due to buildup ofblood or fluidaround the lining of the heart, Perforation of the myocardium or vessel ahole in the heart muscle or a blood vessel, Partial or complete block of coronary artery(that supplies blood to the heart), Ascending aorta trauma injury to the largeblood vessel leading blood away from the heart, Additional cardiac surgery, vascular surgery, orintervention, including removal of the TAV. US MRI safety information - heart valve products Outside the US MRI safety information - heart valve products Contact technical support Contact the Edwards Lifesciences technical support department at 800-822-9837 (USA) or 949-250-2500 for any additional information regarding MRI safety of our products. Indications, Safety, and Warnings Product Details CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI PERMANENT PACEMAKER RATE AT 30 DAYS3, 0 DEATHS Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement*1 so you get greater control when it matters most. Healthcare Professionals TAVR currentlyis approvedfor patients withheart diseasedue to symptomatic severe aortic stenosis of the native valve, and patients with a failingsurgical aortic valve who are at high risk or extreme riskdue to symptomatic, severe aortic stenosis for complications during surgery. Transcatheter aortic valve (bioprosthesis) Accelerated deterioration due to calcific degeneration of the bioprostheses may occur in: children, adolescents, or young adults; patients with altered calcium metabolism (e.g., chronic renal failure or hyperthyroidism). 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. With an updated browser, you will have a better Medtronic website experience. Medtronic MRI Resource Library: Region Click OK to confirm you are a Healthcare Professional. For applicable products, consult instructions for use on manuals.medtronic.com. Anatomical characteristics should be considered when using the valve in this population. Cardiovascular Broadest annulus range based on CT derived diameters. 2010; 121:2123-2129. Lowest delivery profile SPECIFICATIONS Evolut PRO+ TAV R BIOPROSTHESIS Evolut PRO+ 23 mm Valve Evolut PRO+ 26 mm Valve Model Number: EVPROPLUS-23US Size: 23 mm Aortic annulus diameter: 17*/18-20 mm Model Number: EVPROPLUS-26US Size: 26 mm Aortic annulus diameter: 20-23 mm LOADING SYSTEM Evolut PRO+ Loading System Model Number: L-EVPROP2329US The valve can be partially or fully recaptured up to three times prior to the point of no recapture. %%EOF Medtronic Launches Head-to-Head TAVR Study Comparing the Corevalve With an updated browser, you will have a better Medtronic website experience. Select country / region and language . Keep appointments with your doctor. In addition, patient age should be considered as long-term durability of the valve has not been established. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. The bioprosthesis size must be appropriate to fit the patients anatomy. Products Radiopaque gold markers provide a reference for deployment depth and commissure location. The supra-annular leaflet position keeps the working portion of the valve above and unconstrained by the native annulus. Find more detailed TAVRinformation, educationalresources, and tools. PDF PRO TAVR SPECIFICATIONS - asiapac.medtronic.com Prosthesis-patient mismatch: definition, clinical impact, and prevention. More information (see more) The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. Update my browser now. Recapture and reposition PDF Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk 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. Heart Valves and Annuloplasty Rings More. MRI Verify | Medtronic Veuillez slectionner votre rgion. Selecione a sua regio. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. The Evolut PRO+ system offers the lowest delivery profile for 2329 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealingwith an external tissue wrap on all valve sizes. Products Prevent kinking of the catheter when removing it from the packaging. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. Safety Topic / Subject Heart Valves and Annuloplasty Rings. The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO device is Medtronic CoreValve Evolut PRO System, and the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System. Transcatheter Aortic Heart Valves Prior to the procedure, measure the patients creatinine level. With an updated browser, you will have a better Medtronic website experience. The Evolut PRO valve features an external tissue wrap added to the proven platform design. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. More information (see more) Less information (see less). TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Up to 80% deployment. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO device is Medtronic CoreValve Evolut PRO System, and the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis, CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI, CORFLO UltraNon-weightedFeeding TubeStylet RemovedPolyurethangeViasys Healthcard SystemsWheeling, IL, CORFLO, ULTRA 7Enteral Feeding TubeViasys MedSystemsWheeling, IL, Corkscrew Suture Anchor, PEEK Arthrex, www.arthrex.com, Corkscrew Suture Anchor, Titanium, Stainless Steel Arthrex, www.arthrex.com, CorMARK, Biopsy MarkerHologic, www.hologic.com, CorMarkTissue Marker14 gaugeEthicon EndosurgeryCincinnati, OH, CORNERSTONE PSR ImplantMedtronic, Inc., www.medtronic.com- Please refer to the labeling documents available at www.medtronic.com/mri, Coroflex ISAR NEO Sirolimus Eluting, Coronary Artery Stent, B. Braun, www.bbraun.com, Coroflex ISAR Sirolimus Eluting, Coronary Artery Stent, B. Braun, www.bbraun.com, Corograft Arterial Graft L-HydroLabcor Laboratorios Ltda., www.labcor.com, CORolla TAA DeviceCorAssist Cardiovascular Ltd., www.corassist.com, Coronary Vein MarkerMed-Edge, Inc., www.med-edge.info, Cortical bone screw4.5 x 36 mm (titanium alloy)orthopedic implantDePuy ACE Medical Co.El Segundo, CA, Cortical bone screwlarge (titanium alloy)orthopedic implantZimmerWarsaw, I, Cortical bone screwsmall (titanium alloy)orthopedic implantZimmerWarsaw, I, corVCD (implant for vessel coupling)corLife GBR, www.corlife.eu, Corvita EndoluminalGraft for AbdominalAortic Aneurysm27 x 120coil, stent, filterSchneider (USA) Inc.Minneapolis, M, Cosgrove-Edwards Annuloplasty RingModel 4600, heart valveBaxter Healthcare CorporationISanta Ana, CA. Medtronic MRI Verify allows you to look up the MR conditionality of a patient's Medtronic cardiac implantable electronic device based on the information available. Home Heart. November 2016;18(11):67. AccessGUDID - DEVICE: Evolut PRO+ (00763000211127) Healthcare Professionals The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. The Evolut PRO+ system is indicated to treat annulus ranges up to 30 mm in diameter and has the ability to treat the broadest annulus range* of any commercially available TAVR system. 2020 Medtronic. For best results, use Adobe Acrobat Reader with the browser. You just clicked a link to go to another website. 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. Reach out to LifeLine CardioVascular Tech Supportwith questions. Medtronic, www.medtronic.com Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve Evolut PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR).
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