The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (e.g., STS predicted risk of operative mortality score 8% or at a 15% risk of mortality at 30 days). For best results, use Adobe Acrobat Reader with the browser. Heart. Reproduced with Permission from the GMDN Agency. for access down to 5.0 mm vessels with the 23-29 mm valves. Third attempt must be a complete recapture and retrieval from patient. Less information (see less). available. Broadest annulus range*
Click OK to confirm you are a Healthcare Professional. Your Resource for MRI Safety, Bioeffects,& Patient Management. Avoid prolonged or repeated exposure to the vapors.
Aortic transcatheter heart valve bioprosthesis, stent-like framework. 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM The valve can be partially or fully recaptured up to three times prior to the point of no recapture.
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Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. If you continue, you will leave this site and go to a site run by someone else.
Avoid freezing. The Evolut R system is built on the CoreValve platform including a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve. Find more detailed TAVRinformation, educationalresources, and tools. Evolut PRO+ TAVI System
Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Evolut PRO System Sealing + Performance The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Safety Topics ; Home; help (full/part words) . The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. Visit: IMRSER.org, Videos Available on IMRSER include: MRI Safety Training Programs for Levels 1 and 2 MR Personnel, What to Expect During Your MRI, Projectile/Missile Effect videos, and Superconducting magnet quenching shown from both inside and outside the MR system room. Indications, Safety, & Warnings. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Important Safety Information - Transcatheter Aortic Valve Replacement (TAVR) | Medtronic Your browser is out of date With an updated browser, you will have a better Medtronic website experience. Heart. January 2016;102(2):107-113.
MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. 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. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. The next-generation self-expanding transcatheter aortic valve replacement (TAVR) system, the CoreValve Evolut PRO was designed with an outer pericardial skirt to improve valve-sealing performance. Floor polishers are poor MRI system cleaners! Products It is possible that some of the products on the other site are not approved in your region or country. More information (see more) The Evolut FX system incorporates the same supra-annular valve design that has shown hemodynamic performance superior to surgical aortic valve replacement (SAVR) across large-scale, randomized clinical trials. Products As the first Medtronic self-expanding TAVR system approved in China, the Evolut PRO system approval is based on clinical data from more than 32,000 patients, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics (blood flow). Damage may result from forceful handling of the catheter. If you continue, you may go to a site run by someone else.
It is possible that some of the products on the other site are not approved in your region or country. You just clicked a link to go to another website. November 1, 1999;34(5):1609-1617.
Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic DUBLIN, Aug. 24, 2021 /PRNewswire/ --Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut FX TAVR system.
More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. The Evolut PRO+ system is currently the only TAVI platform indicated to treat annulus ranges up to 30 mm diameter and has the ability to treat the broadest annulus range* of any commercially available TAVI system.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The frame oversizing and cell geometry provide consistent radial force across the treatable annulus range. Pibarot P, Dumesnil JG. MRIsafety.com is Exclusively Sponsored by BRACCO, MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials.
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Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland The Evolut TAVR platform (including the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX) is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S. Limited commercial release is planned for the fall with a full launch anticipated in early 2022.
9850 NW 41st Street, Suite 450, Doral, FL 33178 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. Evolut PRO+ Transcatheter Aortic Valve, The next generation EvolutTM PRO+ transcatheter aortic valve system provides industry-leading hemodynamics allowing your patients to return to activity faster.1,2,3, Evolut PRO+ TAVI System Evolut provides an outstanding range of professionally prepared, "return to work" and "safety at work" training courses which you can now complete online at a time and pace suited to your personal situation. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand.
Advanced sealing
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.
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.
Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Aortic transcatheter heart valve bioprosthesis, stent-like framework. For information, visit MagneticResonanceSafetyTesting.com.
Broadest annulus range based on CT derived diameters.
These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. For applicable products, consult instructions for use on manuals.medtronic.com. You may also call800-961-9055 for a copy of a manual.
Evolut PRO. Transcatheter Aortic Heart Valves
Search by the product name (e.g., Evolut) or model number.
Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Object Description Object Status Safety Topic / Subject Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Update my browser now.
With performance at its core, the CBG features a continuous, tapered core and pre-shaped curve for secure deployment. Medtronic, www.medtronic.com Excessive contrast media may cause renal failure. Refer to the Instructions for Use for available sizes.
Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. About MedtronicMedtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies alleviating pain, restoring health and extending life for millions of people around the world. Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body.
Cardiovascular These studies reported consistent data regarding the safety and efficacy of the CoreValve system, and several confirmed its durability out to at least five years. If 2 of these factors are present, consider an alternative access route to prevent vascular complications. A steel oxygen tank is never permitted inside of the MRI system room.
Find safety related information pertaining to thousands of specific implants or devices.
Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM.
document.write(new Date().getFullYear()) by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Healthcare Professionals Conduct the procedure under fluoroscopy. By choosing to accept, you acknowledge that you are a Certified Healthcare Professional. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician.
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.
Cardiovascular The Evolut PRO valve features an external tissue wrap added to the proven platform design. We currently do not have this item in stock, but we can email you as soon as it is available. The safety and effectiveness of the bioprostheses 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 1.0cm2 or aortic valve area index 0.6cm2/m2, a mean aortic valve gradient 40mmHg, or a peak aortic-jet velocity 4.0m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis aortic valve area 1.0cm2 or aortic valve area index 0.6cm2/m2, a mean aortic valve gradient <40mmHg, and a peak aortic-jet velocity <4.0 m/s; 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.
Significant ascending aortopathy requiring surgical repair 2. Avoid exposing to extreme fluctuations of temperature. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Find additional feature information, educational resources, and tools.
Update my browser now. Anatomical characteristics should be considered when using the valve in this population. 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). Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name.
If you continue, you may go to a site run by someone else. August 2006;92(8);1022-1029.
Flameng, W, et al. Safety Info ID# Safety Topic / Subject Article Text 179: Heart Valves and Annuloplasty Rings: Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera. Reach out to LifeLine CardioVascular Tech Supportwith questions. Lowest delivery profile
Special Storage Condition, Specify: Keep dry, Special Storage Condition, Specify: Keep away from sunlight, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 26 MM.
After the procedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment.
Products Third attempt must be a complete recapture and retrieval from patient. CONTROL DURING DEPLOYMENT The Evolut PRO+ delivery system: Assists in accurate positioning of the 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.
The Evolut PRO system goes beyond the CoreValve and Evolut R systems' unique design: a supra-annular, self-expanding nitinol frame with a porcine pericardial tissue valve.
Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. 4 Based on these data, the FDA expanded the indications for CoreValve and the next generation Evolut systems to include patients at intermediate or greater risk for open-heart surgery. Reproduced with Permission from the GMDN Agency. Have access to the minimally invasive TAVI procedure because of the expanded annulus range * Click OK to you! Medtronic, Medtronic, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic ) or number..., hospitals and patients in more than 90,000 people worldwide, serving,! * Click OK to confirm you are a Certified Healthcare Professional not approved in your region or country to... East & Africa find more detailed TAVRinformation, educationalresources, and tools of patient-prosthesis mismatch on exercise in. 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