More than 450,000 people worldwide have had a Medtronic TAVR procedure offering patients the opportunity to return to their active lives. Edwards MC3 tricuspid annuloplasty ring. To enable surgeons to address these trends, we have developed the EDWARDS INTUITY Elite valve system. 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 Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices. With an updated browser, you will have a better Medtronic website experience. The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System, and the commercial name of the Evolut FX device is Medtronic Evolut System. You may also call 800-961-9055 for a copy of a manual. Otto CM, Nishimura RA, Bonow RO, et al. With an updated browser, you will have a better Medtronic website experience. If you consent, analytics cookies will also be used to improve your user experience. Public Relations The safety and effectiveness of the bioprosthesis for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis aortic valve area 1.0 cm2 or aortic valve area index 0.6 cm2/m2, a mean aortic valve gradient 40 mm Hg, or a peak aortic-jet velocity 4.0 m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis aortic valve area 1.0 cm2 or aortic valve area index 0.6 cm2/m2, a mean aortic valve gradient < 40 mm Hg, and a peak aortic-jet velocity < 4.0 m/s; congenital bicuspid valve patients who are at low surgical risk (predicted perioperative mortality risk of < 3%); with untreated, clinically significant coronary artery disease requiring revascularization; with a preexisting prosthetic heart valve with a rigid support structure in either the mitral or pulmonic position if either the preexisting prosthetic heart valve could affect the implantation or function of the bioprosthesis or the implantation of the bioprosthesis could affect the function of the preexisting prosthetic heart valve; patients with liver failure (Child-Pugh Class C); with cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support; patients who are pregnant or breastfeeding. That brings expected full-year . The CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. Raynham, MA. TAVR also demonstrated three times lower severe prosthesis-patient mismatch (PPM) (3.7% vs. 11.8%; p<0.001) at 30-days/discharge compared to surgery, which occurs when the valve is too small for the patient's body size. The bioprosthesis size must be appropriate to fit the patients anatomy. Update my browser now. The Interject Sclerotherapy Needle features a unique star-shaped inner catheter design to help promote reliable needle actuation in tortuous anatomy (even after kinking). Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, Patients with heart diseasedue to symptomatic, severe aortic stenosis of their native valve, Patients with a failing surgical aortic valve who are at high risk or extreme risk for complications during surgery, Serious bleeding (a bleeding event that requires a blood transfusion), Cannot take medications that reduce the risk of blood clots. 2019;380(18):1695-1705. Cardiovascular Table; View full table. Medtronic, www.medtronic.com. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it will participate in the 41st annual J.P. Morgan healthcare conference. Any and all information provided is intended for general overview. Conduct the procedure under fluoroscopy. Home Search by the product name (e.g., Evolut) or model number. The CoreValve and next generation Evolut TAVR systems are used in an aortic valve replacement procedure that is less invasive than traditional open-heart surgery for patients with severe aortic stenosis. There were no significant differences in rates of thrombosis (0.3% TAVR vs 0.2% SAVR, p=0.80) or endocarditis (1.1% TAVR vs. 1.3% SAVR, p=0.68). Explore our valve design and theperformance of the Evolut platform over time. AorTechAorticModel 3800TitaniumHeart ValveAortech Ltd.Strathclyde, U.K. AorTechMitralModel 4800titaniumheart valveAortech Ltd.Strathclyde, U.K. Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 19 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 29 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic SJM Regent ValveMechanical Heart ValveSize 27 mm27AGN-751Rotatable AorticStandard Cuff-Polyester, AGNSt. - (00:40), Watch this brief video comparing deployment stability from Evolut PRO+ to Evolut FX transcatheter aortic valves. Keep appointments with your doctor. Transcatheter Aortic Heart Valves Keep your Medtronic TAVR valve information card with you at all times. These data are summarized in the Instructions for Use and support the findings of the primary analysis. Designed for dependable cardiac and vascular repair XenoLogiX* two-step processing treatment for dependable performance The same tissue with demonstrated long-term durability in Edwards' surgical heart valves** Ready to use after standard rinse duration Easy to suture with dependable suture retention Tissue thickness: 0.5 mm +/- 0.25 mm N Engl J Med. Patients must present with transarterial access vessel diameters of 5mm when using models ENVEOR-US/D-EVPROP2329US/D-EVOLUTFX-2329 or 5.5mm when using model ENVEOR-N-US or 6mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site 60mm from the basal plane for both systems. The Evolut R transcatheter aortic heart valve can be recaptured and repositioned. 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. General Clinical long-term durability has not been established for the bioprosthesis. You may also call 800-961-9055for a copy of a manual. They will be with you throughout the TAVR journey to provide support and answer questions. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Reports from device programmers include references to the model number: Product Name search includes brand or trademark names for many Medtronic products; however, not all products are included. On the basis of available evidence to date, all patients with prosthetic heart valves or coronary stents can safely undergo MRI at 1.5 T and the vast majority at 3 T. What is a Tavr valve made of? Medtronic today announced five-year bioprosthetic valve dysfunction (BVD) data for the CoreValve/Evolut TM platform, the first and only transcatheter aortic valve replacement (TAVR) platform to show significantly better valve performance and durability compared to surgical aortic valve replacement (SAVR) at five years. The surgical heart valve market is evolving. These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system. As of 2015, MRI conditions that are considered safe for patients with a St. Jude heart valve include a static magnetic field of 1.5 Tesla or 3.0 Tesla, a maximum spatial gradient less than or equal to 3,000 Gauss per centimeter, and a maximum whole-body averaged specific absorption rate of 2.0 watts per kilogram for 15 minutes of scanning in . The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of > 30 for right subclavian/axillary access or > 70 for femoral and left subclavian/axillary access. If you have any questions about your TAVR device, reach out to our CardioVascular LifeLine Technical Support by phone or email. Evolut FX System for transcatheter aortic valve replacement (TAVR) The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Implanting a CoreValve Evolut R, Evolut PRO, or Evolut PRO+ bioprosthesis in a degenerated surgical bioprosthetic valve (transcatheter aortic valve in surgical aortic valve [TAV-in-SAV]) should be avoided in the following conditions: The degenerated surgical bioprosthetic valve presents with: a significant concomitant paravalvular leak (between the prosthesis and the native annulus), is not securely fixed in the native annulus, or is not structurally intact (e.g., wire form frame fracture); partially detached leaflet that in the aortic position may obstruct a coronary ostium; stent frame with a manufacturer-labeled inner diameter < 17 mm. "Most heart valves and coronary artery stents currently on the market and implanted in patients can go safely through an MRI scanner," Dr. Flamm says. Product Details TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Update my browser now. These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. With an updated browser, you will have a better Medtronic website experience. Transcatheter Aortic Valve Replacement Mack MJ, Leon MB, Thourani VH, et al. Search by the product name (e.g., Evolut) or model number. Contact Technical Support. Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus. Some patients may take longer to feel better. What is the optimal antithrombotic regimen after transcatheter aortic valve replacement? Medtronic, Inc., www.medtronic.com. Anatomical characteristics should be considered when using the valve in this population. Cardiovascular Improvement may include: How many people have had the Medtronic TAVR procedure? Evolut FX To . The pooled analysis of the CoreValve U.S. Pivotal and SURTAVI Trials evaluated valve performance and durability of surgical and transcatheter valves by incidence of overall BVD which includes structural valve deterioration (SVD), non-structural valve dysfunction (NSVD), thrombosis, and endocarditis. Most medical procedures have risks. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, R System, the commercial name of the Evolut, PRO+ System, and the commercial name of the Evolut, 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, myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade, coronary occlusion, obstruction, or vessel spasm (including acute coronary closure), cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention), emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty), prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement prosthetic valve migration/embolization, delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time, delivery catheter system component migration/embolization, stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits, individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure, major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding), vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis), conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker. 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