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, 8.8% It is possible that some of the products on the other site are not approved in your region or country. Treatments & Therapies The Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. PDF View Shellock R & D Services, Inc. email: . 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). Damage may result from forceful handling of the catheter. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations. Cardiovascular Object Info: - MRI Safety Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . See how the external tissue wrap on the Evolut PRO TAV performs. Transcatheter Aortic Heart Valves | Medtronic You may also call 800-961-9055 for a copy of a manual. 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 Heart. EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. The external wrap increases surface contact with native anatomy, providing advanced sealing. Products 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 . Follow all care instructions to ensure the best possible results. Bench testing may not be indicative of clinical performance. You may also call 800-961-9055for a copy of a manual. November 1, 1999;34(5):1609-1617. Products It is possible that some of the products on the other site are not approved in your region or country. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. A number of factors determine a patients risk, including age and other medical conditionsthat make surgery more dangerous. . During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Your use of the other site is subject to the terms of use and privacy statement on that site. Broadest annulus range* 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. Loading System: L-EVPROP2329US; Delivery Catheter System: D-EVPROP2329US 2010; 121:2123-2129. 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 Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Update my browser now. endstream endobj startxref General Clinical long-term durability has not been established for the bioprosthesis. `)\;>! PRODUCT DETAILS EXCEPTIONAL DESIGN Find MRI Technical Information (select one) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. Broadest annulus range* AccessGUDID - DEVICE: Evolut PRO+ (00763000211127) Prosthesis-patient mismatch: definition, clinical impact, and prevention. Anatomical characteristics should be considered when using the valve in this population. All other brands are trademarks of a Medtronic company. 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. Keep appointments with your doctor. For applicable products, consult instructions for use on manuals.medtronic.com. hb```lu eah(x B Less information (see less). X'AD`4.$ 2 * Third party brands are trademarks of their respective owners. Dahou A, Mahjoub H, Pibarot P. Prosthesis-Patient Mismatch After Aortic Valve Replacement. Update my browser now. 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. Medtronic MRI Resource Library: Home This library contains technical information on whether an MRI scan can be performed and how to perform a scan on patients with Medtronic implantable devices. January 2016;102(2):107-113. All other brands are trademarks of a Medtronic company. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Manuals can be viewed using a current version of any major internet browser. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. Medtronic, www.medtronic.com At some point, the Medtronic TAVR valve may need tobe replaced. TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. Select country / region and language . Products * Third party brands are trademarks of their respective owners. %PDF-1.5 % The external wrap increases surface contact with native anatomy, providing advanced sealing. 2010; 121:2123-2129. Or, you may contact technical support online. With an updated browser, you will have a better Medtronic website experience. Go . 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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Update my browser now. Indications, Safety, and Warnings Product Details Cardiovascular The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. Safety Info ID# Safety Topic / Subject Article Text 179: . If 2 of these factors are present, consider an alternative access route to prevent vascular complications. With an updated browser, you will have a better Medtronic website experience. Evolut PRO China Clinical Study - Full Text View - ClinicalTrials.gov You may also call800-961-9055 for a copy of a manual. Home Manuals can be viewed using a current version of any major internet browser. Evolut FX. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. Object Info: - MRI Safety More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. $/R$J101 Transcatheter Aortic Heart Valves The Evolut R valve was built on the proven design of our CoreValve platform and features a supra-annular, self-expanding nitinol frame with a low delivery profile. 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 <4.0m/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.