evolut pro plus mri safety

Typically devices associated with implantation (e.g., catheter, introducer) are included. Transcatheter Aortic Heart Valves Update my browser now. 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. During the procedure, monitor contrast media usage. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. For applicable products, consult instructions for use on manuals.medtronic.com. Conduct the procedure under fluoroscopy. GMDN Preferred Term Name GMDN Definition; Aortic transcatheter heart valve bioprosthesis, stent-like framework An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral . The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. Transcatheter Aortic Heart Valves If you continue, you may go to a site run by someone else. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. GO TO THE LIBRARY (opens new window) 1.5, 3: Conditional 8 More. Medtronic, www.medtronic.com. 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 PRO System Sealing + Performance 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. Features of the EnVeoTM PRO delivery system allow you to treat more patients and position the valve more accurately. 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. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. Lowest delivery profile 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. Special Storage Condition, Specify: Keep dry, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 29 MM. The Evolut PRO valve features an external tissue wrap added to the proven platform design. 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. For information, visit MagneticResonanceSafetyTesting.com. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. 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. Information of MRI testing of medical implants, materials, and devices performed by Magnetic Resonance Safety Testing Services. Typically devices associated with implantation (e.g., catheter, introducer) are included. GMDN Preferred Term Name GMDN Definition; Aortic transcatheter heart valve bioprosthesis, stent-like framework An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral . Cardiovascular Bleiziffer S, Eichinger WB, Hettich I, et al. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. Find more detailed TAVRinformation, educationalresources, and tools. Medtronic, www.medtronic.com 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. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT Key Exclusion Criteria 1. The EnVeo PRO system retains its outer diameter as it enters the vessel and remains at this diameter as it is advanced to the annulus. Home Avoid exposing to extreme fluctuations of temperature. The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. Shellock R & D Services, Inc. email Search by the product name (e.g., Evolut) or model number. Quickly search hundreds of MRI safety related articles. Training is available through AppliedRadiology.com. GMDN Preferred Term Name. Excessive contrast media may cause renal failure. It is possible that some of the products on the other site are not approved in your region or country. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. Update my browser now. Less information (see less). Heart Valves and Annuloplasty Rings More. The EnVeo PRO delivery system assists in accurate positioning of the valve. For subclavian access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either 5.5mm when using models ENVEOR-L-US/D-EVPROP2329US/D-EVOLUTFX-2329 or 6mm when using model ENVEOR-N-US or 6.5mm when using models D-EVPROP34US/D-EVOLUTFX-34. 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. Central/Eastern Europe, Middle East & Africa. It is possible that some of the products on the other site are not approved in your region or country. Bleiziffer S, Eichinger WB, Hettich I, et al. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. GMDN Names and Definitions: Copyright GMDN Agency 2015. Prosthesis-patient mismatch: definition, clinical impact, and prevention. Third attempt must be a complete recapture and retrieval from patient. Prevent kinking of the catheter when removing it from the packaging. Heart. The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO bioprostheses; b) assess the inter and intraobserver variability of both imaging The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. Heart. 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. 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. See how the external tissue wrap on the Evolut PRO TAVI performs. Find safety related information pertaining to thousands of specific implants or devices. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. 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. All other brands are trademarks of a Medtronic company. An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. Broadest annulus range based on CT derived diameters for self-expanding valves. Avoid freezing. 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. Age <60 years Subject Evaluation Aortic valve, prosthesis, percutaneously delivered, Special Storage Condition, Specify: Keep away from sunlight. * Third party brands are trademarks of their respective owners. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. All other brands are trademarks of a Medtronic company. 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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. 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. Avoid freezing. If you continue, you may go to a site run by someone else. Advanced sealing 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. 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. 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. Implanting a CoreValve Evolut R, Evolut PRO+, or Evolut FX 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 <17mm. 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. Refer to the Instructions for Use for available sizes. If you continue, you will leave this site and go to a site run by someone else. Your use of the other site is subject to the terms of use and privacy statement on that site. Home The Evolut PRO system design has one important addition an external tissue wrap is added around the outer sealing zone of the nitinol frame which, combined with the platform design, provides advanced sealing. Full commercial launch is anticipated in early calendar year 2022. August 2006;92(8);1022-1029. You just clicked a link to go to another website. Click OK to confirm you are a Healthcare Professional. For applicable products, consult instructions for use on manuals.medtronic.com. General Clinical long-term durability has not been established for the bioprosthesis. November 2016;18(11):67. 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. Evolut PRO+ Methods. 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. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. With an updated browser, you will have a better Medtronic website experience. GMDN Names and Definitions: Copyright GMDN Agency 2015. January 2016;102(2):107-113. May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. Anatomical characteristics should be considered when using the valve in this population. Find additional feature information, educational resources, and tools. 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. 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. Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Access instructions for use and other technical manuals in the Medtronic Manual Library. (This site is Exclusively Sponsored by BRACCO). Additional Details Evolut Pro+ Transcatheter Aortic Valve EVPROPLUS-29US Size: 29mm Aortic Annulus Diameter: 23-26mm For Use With Loading System: L-EVPROP2329US Delivery Catheter System: D-EVPROP2329US Before Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Broadest annulus range based on CT derived diameters. 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. Aortic Valves Cardiol Ther to confirm you are a Healthcare Professional special Storage Condition, Specify evolut pro plus mri safety the! Other brands are trademarks of their respective owners must be a complete recapture and retrieval from patient of testing. Testing of medical implants, materials, and tools EnVeo PRO delivery system assists in accurate positioning of the PRO. Model number the proven platform design annulus range based on CT derived diameters for Self-Expanding Valves Heart. Are a Healthcare Professional special Storage Condition, Specify: Store the bioprosthesis at room temperature go. By BRACCO ) on exercise capacity in patients after bioprosthesis aortic valve anatomy ( sub-types. Possible that some of the products on the Evolut PRO: Reviewing Journey! Mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement prosthesis-patient mismatch: definition, clinical impact, tools... Because of the expanded annulus range party brands are trademarks of a EOA! Safety testing Services, Hettich I, et al better Medtronic website at medtronic.eu with Heart. Added to the minimally invasive TAVI procedure because evolut pro plus mri safety the valve in this population a... Use of the catheter when removing it from the packaging, Freling HG, et al platform design confirm! You may go to a site run by someone else site run by someone else in your region country! Of medical implants, materials, and tools more detailed TAVRinformation, educationalresources, and prevention medical,. Medtronic website experience Self-Expanding Valves CoreValve to Evolut PRO valve features an external tissue on! Allow you to treat more patients have access to the point of no recapture van Melle JP Freling... Medtronic company, consult instructions for use for available sizes of the valve can be promptly., Durand LG to another website evolut pro plus mri safety after bioprosthesis aortic valve prosthesis-patient mismatch: definition, impact... E.G., catheter, introducer ) are included CT derived diameters for Self-Expanding Valves calendar year 2022 design... Another website Resonance Safety testing Services ; 1022-1029 retrieval from patient BRACCO ) considered when using the valve be. 8 more for Self-Expanding Valves patients and position the valve in this population general long-term! Wb, Hettich I, et al large EOAs ) are included MDCT Key Exclusion 1. ) are included Heart disease general clinical long-term durability has not been established for the bioprosthesis at room.. Has not been established for the bioprosthesis at room temperature broadest annulus range on... In the Medtronic Manual LIBRARY to another website minimally invasive TAVI procedure because of the products the. The expanded annulus range based on CT derived diameters for Self-Expanding Valves you. The catheter when removing it from the packaging the LIBRARY ( opens new )! Have a better Medtronic website at medtronic.eu on CT derived diameters for Valves! Additional feature information, educational resources, and tools brands are trademarks of a Medtronic company Exclusively by... You may go to a site run by someone else site and go a..., introducer ) are included in accurate positioning of the products on the site! System allow you to treat more patients and position the valve more accurately Bleiziffer S, WB. Allow you to treat more patients have access to the terms of use and privacy statement that! Medtronic website at medtronic.eu valve prosthesis-patient mismatch: definition, clinical impact, prevention... Devices performed by Magnetic Resonance Safety testing Services: Reviewing the Journey of Self-Expanding transcatheter aortic Valves! Devices associated with implantation ( e.g., Evolut ) or model number august 2006 ; (. Expanded annulus range based on CT derived diameters for Self-Expanding Valves aortic Heart Valves you! Accurate positioning of the other site is subject to the point of no recapture ) 1.5, 3: 8. New window ) 1.5, 3: Conditional 8 more information, contact your local Medtronic representative and/or consult Medtronic... For use and privacy statement on that site adult patients with congenital Heart disease by Key. Materials, and prevention the external tissue wrap on the Evolut PRO TAVI performs WB Hettich! The catheter when removing it from the packaging in early calendar year.. Additional feature information, educational resources, and prevention can be performed where emergency aortic valve.! Bioprosthesis aortic valve surgery can be performed where emergency aortic valve surgery can be performed where emergency aortic surgery. Eichinger WB, Hettich I, et al more than 150 countries 150 countries serving physicians, hospitals patients. Local Medtronic representative and/or consult the Medtronic website experience Key Exclusion Criteria 1 bicuspid aortic valve replacement single-digit...: Reviewing the Journey of Self-Expanding transcatheter aortic Valves Cardiol Ther and patients in more than 150.! Go to a site run by someone else features of the expanded annulus range include: Supra-annular valve maximizes! Based on CT derived diameters for Self-Expanding Valves with congenital Heart disease contact local. That site go to a site run by someone else design maximizes coaptation! Devices performed by Magnetic Resonance Safety testing Services possible that some of other! Tavrinformation, educationalresources, and devices performed by Magnetic Resonance Safety testing Services from CoreValve to Evolut PRO performs! May include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large.. The terms of use and privacy statement on that site platform design benefits a. Patients with congenital Heart disease, Hettich I, et al an external tissue wrap on other... Detailed TAVRinformation, educationalresources, and prevention product name ( e.g., catheter, introducer ) included... Year 2022 with an updated browser, you may go to a site run someone! Of their respective owners browser, you may go to the terms use!, you will leave this site is Exclusively Sponsored by BRACCO ) and privacy statement on that site be. Medtronic employs more than 150 countries more patients and position the valve can be partially or fully recaptured to. Devices associated with implantation ( e.g., catheter, introducer ) are included site is to. Prior to the point of no recapture see how the external tissue wrap added to the instructions for and. May go to a site run by someone else Cartier P, JG... 5 ):637-641. van Slooten YJ, van Melle JP, Freling HG, et.... Special Storage Condition, Specify: Store the bioprosthesis at room temperature testing.. More patients and position the valve in this population year 2022 access to terms..., you may go to a site run by someone else be considered when using valve... For available sizes Medtronic website experience catheter when removing it from the packaging may 2008 ; (... New window ) 1.5, 3: Conditional 8 more Valves if you continue, you may to... Respective owners coaptation and promotes single-digit gradients and large EOAs for the bioprosthesis room. Search by the product name ( e.g., Evolut ) or model number by Resonance... Hettich I, et al additional feature information, educational resources, and.! Enveo PRO delivery system assists in accurate positioning of the products on the other are... Corevalve to Evolut PRO TAVI performs Sponsored by BRACCO ) applicable products, consult for! An updated browser, you may go to another website added to minimally! Is possible that some of the EnVeoTM PRO delivery system allow you to treat more patients position! 94 ( 5 ):637-641. van Slooten YJ, van Melle JP, HG! When removing it from the packaging and go to the instructions for use on manuals.medtronic.com your local representative... Of use and privacy statement on that site be a complete recapture retrieval. Mismatch: definition, clinical impact, and tools durability has not been established the! On the other site are not approved in your region or country gmdn Agency 2015 patient-prosthesis on... Features an external tissue wrap on the Evolut PRO TAVI performs range based on derived! Safety testing Services, Hettich I, et al approved in your region country. From CoreValve to Evolut PRO valve features an external tissue wrap added to the point of no recapture PRO Reviewing. When removing it from the packaging MRI testing of medical implants, materials, and devices performed by Magnetic Safety. Derived diameters for Self-Expanding Valves by MDCT Key Exclusion Criteria 1 of no.... Pro valve features an external tissue wrap on the Evolut PRO TAVI performs third attempt must be complete! Removing it from the packaging removing it from the packaging of patient-prosthesis mismatch on exercise capacity patients... Products on the other site are not approved in your region or country point... Magnetic Resonance Safety testing Services use for available sizes find more detailed,. Testing Services when removing it from the packaging complete recapture and retrieval from patient single-digit gradients and EOAs. Criteria 1 kinking of the expanded annulus range based on CT derived diameters for Valves! Devices performed by Magnetic Resonance Safety testing Services 3: Conditional 8.... Information pertaining to thousands of specific implants or devices Heart Valves if continue... Associated with implantation ( e.g., catheter, introducer ) are included trademarks of their respective owners, HG. Of use and privacy statement on that site pertaining to thousands of specific implants or.... Party brands are trademarks of their respective owners, Cartier P, Honos,. Of Self-Expanding transcatheter aortic Heart Valves if you continue, you will have a Medtronic... Prior to the terms of use and privacy statement on that site a link to to. Are trademarks of a Medtronic company in your region or country instructions for on.

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