medtronic evolut pro valve mri safety medtronic evolut pro valve mri safety

All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. 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. Flameng, W, et al. 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. Reach out to LifeLine CardioVascular Tech Supportwith questions. EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. 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. Manuals and technical guides The Evolut PRO+ system offers the lowest delivery profile for 23-29 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealing with an external tissue wrap on all valve sizes. See how the external tissue wrap on the Evolut PRO TAVI performs. 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. English. 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. The bioprosthesis size must be appropriate to fit the patients anatomy. Medtronic MRI Resource Library: Region PDF PRO TAVR SPECIFICATIONS - asiapac.medtronic.com The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Search by the product name (e.g., Evolut) or model number. $/R$J101 Your dentist and all doctors need to know about your Medtronic TAVR valve. This study is a prospective, single arm, multi-center . For some patients, the Medtronic TAVR procedure risks may outweigh the benefits. Search by the product name (e.g., Evolut) or model number. Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: $G` Products If you require an MRI scan, tell the doctor that you have a Medtronic TAVR valve. 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. Evolut FX - Transcatheter Aortic Heart Valves | Medtronic The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. You may also call 800-961-9055for a copy of a manual. 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. MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS Heart. Broadest annulus range based on CT derived diameters. PDF Summary of Safety and Effectiveness Data I. General Information Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. 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). PDF View Shellock R & D Services, Inc. email: . Up to 80% deployment. Evolut PRO System Sealing + Performance Broadest annulus range based on CT derived diameters. Patients should stay onmedications that reduce the risk of blood clots after the procedure as instructed by your physician. Multiple clinical trials havebeen conductedto provide information about the chance of a risk from the Medtronic TAVR procedure. Transcatheter Aortic Heart Valves General surgical risks applicable to transcatheter aortic valve implantation: abnormal lab values (including electrolyte imbalance, allergic reaction to antiplatelet agents, contrast medium, or anesthesia, exposure to radiation through fluoroscopy and angiography. Medtronic Announces CE Mark of Evolut PRO+ TAVI System for Treatment Approval Order: Approval Order: Summary: Summary of Safety and Effectiveness . Learn how the Evolut platform isdesigned to go beyond proceduraloutcomes to benefit your patients. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. The Evolut PRO+ TAVI System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest annular range (for self-expanding TAVI technology) on the market. With an updated browser, you will have a better Medtronic website experience. The Medtronic TAVR valve has not been studied in patients: If the Medtronic TAVR valveis usedin these patients, it may not work right. Patients who do not are more likely to have a stroke. Object Info: - MRI Safety Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement*1 so you get greater control when it matters most. Selezionare la propria regione. Update my browser now. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). THE List - MRI Safety Update my browser now. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. Circulation. Transcatheter Aortic Heart Valves | Medtronic You may also call 800-961-9055 for a copy of a manual. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. 4564 0 obj <>/Filter/FlateDecode/ID[<2C0E24D68A9BFB4295F1AF0A6EE224DC>]/Index[4544 45]/Info 4543 0 R/Length 94/Prev 676184/Root 4545 0 R/Size 4589/Type/XRef/W[1 2 1]>>stream Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Select country / region and language . Search by the product name (e.g., Evolut) or model number. Heart Valves and Annuloplasty Rings More. Lowest delivery profile Your doctor can let you know which risks will most likely apply to you. Object Category Heart Valves and Annuloplasty Rings. See how the external tissue wrap on the Evolut PRO TAV performs. Bitte whlen Sie Ihre Region. endstream endobj 4545 0 obj <. Medtronic MRI Resource Library: Home The Evolut PRO valve features an external tissue wrap added to the proven platform design. %%EOF - (03:56), See how the porcine pericardial tissue wrap on the Evolut PRO transcatheter aortic valve provides advanced sealing and performance. See the CoreValve Evolut R, the CoreValve Evolut PRO and the Evolut PRO+ device manuals for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.