Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Surgical Heart Valve Repair and Replacement. Prosthetic heart valves: Part 3 - Imaging - European Society of Ozeren M, DoGan OV, Dolgun A, Koyildirim E, Karapinar K, Ycel E. J Heart Valve Dis. This site is Exclusively Sponsored by BRACCO, Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices, Orthopedic Implants, Materials, and Devices, Neurostimulation (Neuromodulation) Systems: General Information, Ocular Implants, Lens Implants, and Devices. sharing sensitive information, make sure youre on a federal Prosthetic heart valves: Evaluation of magnetic field interactions The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). HHS Vulnerability Disclosure, Help %PDF-1.4 % Accessibility Van Nooten GJ, Caes F, Francois K, et al. medtronic open pivot heart valve mri safety Cocchia R, Chianese S, Lombardi G, Romano L, Capone V, Amitrano L, Bennato R, Ranieri B, Russo G, Mauro C, Bossone E. Clin Pract. Your doctor will help you evaluate the progress of your condition after surgery. Easy Implantability With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. Sezai A, Shiono M, Orime Y, et al. Is it safe to have a magnetic resonance imaging (MRI) scan after heart valve replacement? Between June 1992 and June 2002, 177 patients (63 male and 114 female; mean age 57.5 years) underwent mitral replacement with an ATS Open Pivot mechanical heart valve. Translational and rotational forces on heart valve prostheses subjected Seventy-four mitral valve replacements (42%) were associated with other cardiac procedures. 2009;18(4):445-452. In vitro assessment of flow patterns and turbulence intensity in prosthetic heart valves using generalized phase-contrast MRI. PMC Object Category Heart Valves and Annuloplasty Rings. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Tell your doctor if you have dramatic, unexplained weight gain, fever, pain, or other symptoms. Update my browser now. Previous reports have focused on the low rate of thromboembolic complications in the aortic position. PDF View Shellock R & D Services, Inc. email: Frank.Shellock @MRIsafety . ;~" ^[L@3CFq#5 LPS PDF Guidelines for Managing Patients with Heart Valve Prostheses - ISMRM This is a preview of subscription content, access via your institution. Before Single-center outcome analysis of 1,161 patients with St. Jude medical and ATS open pivot mechanical heart valves. Magnetic resonance imaging is a safe technique in patients with Overall operative mortality was 1.8% (AVR = 2.8%, MVR = 0%), with only one valve-related death. The paper refers to the safety of MRI in patients with prosthetic heart valves or coronary stents. 2023 Springer Nature Switzerland AG. 8600 Rockville Pike Medtronic, Inc. 2007. mVa04iv2Y Teflon: ATS Medical Inc., Minneapolis, MN: 27: SJM Reagent Valve: Bileaflet: Aortic: 25AGN-751-IDE: 25: Polyester: Mechanical Heart Valve: St. Jude Medical Inc . It allows both morphologic and haemodynamic assessment according to the current guidelines [1,2]. The main advantage of a tissue valve is that it does not typically require life-long blood-thinning medication. National Library of Medicine 2018 Apr;31(4):475-490. doi: 10.1016/j.echo.2018.01.011. Federal government websites often end in .gov or .mil. The .gov means its official. Our heart valves have been tested and found to be compatible during an MRI scan under specific conditions. Before The aortic valve tissue. Handle the valve only with accessories provided by the manufacturer specifically for the Carbomedics valve . J Heart Valve Dis. After that, he or she will look at your risk factors to see if you need to continue on the medication. What are complications with heart valve replacement surgery? Krian A. % kfdSL`FgW. )wMt+T)ooVn,K >d_BPry6)5L>E^2AKYjz%Ae/^` W,(zuPd)kEJU{n {VX A good cardiac rehabilitation program helps you regain your energy and overall good health. 4 0 obj Clipboard, Search History, and several other advanced features are temporarily unavailable. E@,6{8^(}?hP%OJ!p M4#b@Za@ J& endstream endobj 37 0 obj <> endobj 38 0 obj <> endobj 39 0 obj <>stream The fact that tissue valves may not require life-long blood-thinning medication makes them ideal for women in their childbearing years, elderly patients, and patients who can't tolerate anticoagulation medication. Multimodality Imaging Assessment of Prosthetic Heart Valves. ATS Medical Open Pivot Valve: Mechanical bileaflet . Unable to load your collection due to an error, Unable to load your delegates due to an error. 8600 Rockville Pike Severe Stenosis of Mitral Bioprosthetic Valve Thrombosis in a Patient with HCV-Related Cirrhosis and Duodenal Variceal Bleeding: The Deadly Triad. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. . comediantes de puerto rico; rivian r1s size comparison; stephen sackur illness The goal of an artificially placed valve is to function like a native one in terms of hemodynamics and with minimal side . Can I have an x-ray after heart valve replacement? These improvements led to low thromboembolic rates of 1.25% per patient year and encouraged a reduction in anticoagulation treatment to an INR of 1.5 to 2.5 in isolated aortic valve replacement cases [ 179 ]. Cardiovascular ])Q Bookshelf Mechanical valves in some patients have lasted as long as 25 years without problems.1, Tissue valves in some patients have lasted as long as 15 years without problems.2. This device may also be used to replace a previously implanted aortic prosthetic heart valve. SAFETY OF ST. JUDE MEDICAL VALVES AND ANNULOPLASTY RINGS . Heart Surgery Forum. Etched into both leaflets is "DEMO/031". Your doctor can provide more details. Bethesda, MD 20894, Web Policies Thus at present, most centers consider all implanted heart valves and annuloplasty rings conditionally safe for MR imaging up to 3.0T, and do not require any waiting period after surgery before they can be scanned. For others, it may take longer to notice a change. 2010;139:1494-1500. 2001 Sep;10(5):628-35. Long-term follow up of patients undergoing reoperative surgery with aortic or mitral valve replacement using a St. Jude Medical prosthesis. Disclaimer. Cardiovascular Ann Thorac Surg. How soon after surgery can I expect to see results? Careers. 2007 Jan;100 Spec No 1:19-28. Mechanical Valves: Tissue Valves: Annuloplasty Rings: xxA-101 or xxM-101 B10 . When a mechanical heart valve opens and closes, you may hear two distinct clicking sounds. Baykut D, Grize L, Schindler C, Keil AS, Bernet F, Zerkowski HR. Learn more on the transportation safety administration website. Emery RW, Van Nooten GJ, Tesar PJ. Unable to load your collection due to an error, Unable to load your delegates due to an error. LifeLine CardioVascular Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . government site. THE List - MRI Safety ATS Medical Open Pivot Bileaflet Heart Valve AP 360 Aortic Model # XX denotes size 505DAxx The ATS Medical Open Pivot mechanical heart valve was introduced in 1992. official website and that any information you provide is encrypted You may need to take antibiotics before you have dental work or other surgery. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Heart Surg Forum. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. This newly developed valve has many outstanding features: open-pivot structure, wider orifice area, improved durability, reduced energy loss, and rotatable orifice. Proven Graft Material The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. All mechanical valves make a little noise. Object Info: - MRI Safety z6s_ !faph n&RZS~v9'URlEtlH {S']$:I&L[z8! This condition is commonly regarded as a contraindication for MRI, where patients with these stents or valves are excluded from yielding the diagnostic imaging information provided by one of the most i Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Five-year follow up of the ATS mechanical heart valve. It is also known as the ATS Open Pivot Bi-leaflet Heart Valve. Your Medtronic heart valve products should not activate airport security alarms, depending on the sensitivity of the security system settings. x]]6r}`D#sIJ==>X~$k=f}.>$VNL,n}~+*+V0O4+? Patients 2021 Feb;11(2):490-501. doi: 10.21037/qims-20-670. November 1999;22(11):754-763. Broadly, they can be classified into three categories: mechanical heart valves, bioprosthetic valves, and homograft. Circ Cardiovasc Imaging. Jamieson WR, Pelletier LC, Janusz MT, Chaitman BR, Tyers FO, Miyagishima RT. Sezai A, Hata M, Niino T, et al. If I have a tissue heart valve implanted, will I need to take any medications after my surgery? If I have a mechanical heart valve implanted, will I need to take medications after my surgery? Home ;I22P0BYG. KC_:*`Y:>/JL&NgyuQr5mj?>Tt5b.-V;Wsym9]VAs>ooFQ-?IJ5JUnF.z:q MR6NUz:-IhyZD-O&A~/#KRZ4j~S6Ch!45in,-n-EjV6aZj[OFYzT69\*gT*4b(ae7t>\0*jYuMS:;ygA G+aJ9-Hk The ATS Medical Open Pivot mitral valve demonstrates low rates of bleeding, thromboembolic, and other valve-related complications. The On-X aortic heart valve is the only mechanical valve FDA approved and clinically proven to be safer with less anticoagulation. On the second postoperative day, 100 mg acetylsalicylic acid and oral acenocoumarol (Sintrom) was introduced to obtain a target INR of 2.0 to 3.0. FOIA Will a mechanical heart valve set off airport security? Heart Valves Surgical Federal government websites often end in .gov or .mil. N[r}jauw&cb2CX@|~_/W&#_H2CSo The Medtronic Open Pivot AP360, AP, and Standard valves provide exceptional implantability, performance, and durability.1-3, Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. This process is experimental and the keywords may be updated as the learning algorithm improves. Heart Valves Surgical You may need other medications, depending on your overall health and the particular nature of your valve disease. ATS Valve - an overview | ScienceDirect Topics 10-year experience with the ATS mechanical valve in the mitral - PubMed Ozeren M, DoGan OV, Dolgun A, Koyildirim E, Karapinar K, Ycel E. J Heart Valve Dis. [kq|XJGzc9H ,s>1B/e j. Prevalence and Evolution of Susceptibility-Weighted Imaging Lesions in Patients With Artificial Heart Valves. government site. You may need to take antibiotics before you have dental work or other medical procedures done, just as you would if you received a mechanical valve. Background: Of course, how quickly you recover depends on the kind of surgery you had, your overall strength, and how well your incision heals. heart valve ATS Medical Minneapolis, M. 1.5: Conditional 5 More. 8$ESTd8]c"[ 6K.mKI05gveIUQ&,Rf|TZO"\ |3 On-X Life Technologies, Inc. - Designed for Life March 1993;17(3):538-545. Would you like email updates of new search results? sharing sensitive information, make sure youre on a federal x[7} */ qY"zfz!'Rklo"d'Ddx~J/Vw\nJZ[%Ei]v'Z.V#p`m4$7oca$`J_^:,yZp3c!}33@-+7CV Mechanical Heart Valve Size 27 mm 27AGN-751 Rotatable Aortic . There are advantages and disadvantages with either choice. Diagnostics (Basel). In this article, we present the results of 15 years of follow-up of patients who have undergone ATS heart valve replacement at our hospital. stream Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. /+~g:Ye,Z6oc:&-wz%L,~#4:Yi~a nSQw2b!ZhWg"yod&NRq_T&8!I aB`789 ?F'`wuM&SAk{s;kq17t-XEHX&V e~{L~x5#Jz9-@\/!BpQgjZ$EPQhdJ?|P(;8XH>T[U4j+ Click OK to confirm you are a Healthcare Professional. MR safety: cardiac valves - Questions and Answers in MRI 2001 Sep;10(5):628-35. This site needs JavaScript to work properly. Overall hospital mortality was 2.8% (5 patients). Home Typically, recovery takes at least eight weeks and up to 12 weeks. Aortic and Mitral Valve Surgery - FAQ | Medtronic Proven Graft Material With an updated browser, you will have a better Medtronic website experience. MeSH Skip to main content English Magnetic resonance imaging is a safe technique in patients with -utZFF-[YrhRdyZO+*__UU[jUM8oi= Download preview PDF. ATS Medical Open Pivot Bileaflet Heart Valve Standard Aortic Model # XX denotes size 500FAxx ATS Medical Minneapolis, M. Strength 3. Data represent 724 total patient-years. FAQ. Arch Mal Coeur Vaiss. From January 1, 1997 through June 30, 2000, 224 patients underwent valve replacement with the ATS Medical cardiac valve prosthesis under a USFDA-approved investigational device exemption study. Before Aortic and Mitral Valve Replacement National Library of Medicine oM4]};A,r\)_p uZCRX_ta|KhC mq5\cs>`>+|xKz10& &,xO\s&8?[$X?~kF$>GOW$\p$1NXMB#nw0S)I]KYSb]c^v.>:vk@^ G7$%tnyQ !f!9x~+i~P=_/rQGl7zkJz!e rYj*" ~pp1pn;jTn*M[*HI f,/Afd. The initial United States experience with the ATS mechanical - PubMed Recovery time depends on many different things, including your overall physical condition before surgery. 2019 Aug 6;8(15):e012814. Etiologies included degenerative disease (56%), rheumatic disease (38%), and endocarditis (6%). Clinical results of a large series of ATS valve implants. Fifteen years of experience with ATS mechanical heart valve prostheses. #b2(jJ4'>+J!K_=g 74G@qdCynoz>\jE|h0/1m2o~~rZpwMpfD Chen CW, Tseng YH, Lin CC, Kao CC, Wong MY, Ting H, Huang YK. THE List - MRI Safety The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. The ATS Medical valve is manufactured in two models: the standard model and the advanced performance (AP) model. 2003 Feb;75(2):444-52. doi: 10.1016/s0003-4975(02)04537-x. HHS Vulnerability Disclosure, Help Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . 1984 Sep;88(3):324-33. Transthoracic echocardiography (TTE) is the primary non-invasive imaging modality for evaluation of mechanical as well as bioprosthetic valves (BPVs). heart valve ATS Medical Minneapolis, M. 1.5: Conditional 5 More. Copyright 2018 Hellenic Society of Cardiology. Many people experience relief from symptoms right away. hbbd``b`@q"w@1zb7A @'HX @Hp?g$jg2012lH{B ], @ _ endstream endobj startxref 0 %%EOF 99 0 obj <>stream J Thorac Cardiovasc Surg. Table # Referenced products MR Safety Table 1 Solo Smart Carbomedics Annuloflex MR Safe Table 2a Carbomedics Prosthetic Heart Valve (CPHV) . This is normal. }qiKy{S,Mu;7#OWWMW|V^\zKltNe4kaKv?%9aB{\gfDSJk.nZ(zhz\ +o%beN`*''CXgk qhJi2?f-eg INDICATION FOR USE The SJM Regent Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. J Am Soc Echocardiogr. Treatments & Therapies It has a low profile bi-leaflet valve with a polyester sewing ring. The https:// ensures that you are connecting to the Open Pivot Aortic Valved Graft - Surgical Heart Valves Your use of the other site is subject to the terms of use and privacy statement on that site. Unauthorized use of these marks is strictly prohibited. No other complications such as paravalvular leak, valve dysfunction, thrombosis, or valve explant occurred. Clipboard, Search History, and several other advanced features are temporarily unavailable. PDF Subject: Magnetic Resonance Imaging (MRI) Information for LivaNova Healthcare Professionals All replacement heart valves are completely safe with x-ray exams. doi: 10.1161/CIRCIMAGING.115.003703. Disclaimer. A mechanical valve lasts longer than a tissue valve, but you'll have to be on blood-thinning medication for the rest of your life to reduce the risk of blood clots. Clinical results of the ATS prosthetic valve in 240 implants and review of the literature. Ask whether you should take antibiotics before surgical or dental procedures to help prevent valve infections. This condition is commonly regarded as a contraindication for MRI, where patients with these stents or valves are excluded from yielding the diagnostic imaging information provided by one of the most important noninvasive imaging modalities. The AP series expands applications for the small aortic root or other situations where hemodynamics are critical. {SY:;u?b- |`+O1EV2,6&KXfti0(yrNgFT(iIeiDGhQkn9Hdq13zFIqCX'ShBL1P ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. Mosaic Bioprosthesis: Ten year Clinical Update. Mackensen GB, Lee JC, Wang DD, Pearson PJ, Blanke P, Dvir D, Kirkpatrick JN. During this time, you'll gradually regain your energy and should be able to return to your normal routine. 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. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. 2001; 4(4):346-353. 2015 Sep;8(9):e003703. With an updated browser, you will have a better Medtronic website experience. Even a simple procedure like cleaning your teeth can dislodge bacteria that could find their way to your heart valve and cause an infection. It is possible that some of the products on the other site are not approved in your region or country. Int J Artif Organs. Federal government websites often end in .gov or .mil. In 372 patient-years of follow-up, there were an additional four patient deaths, two of which were valve related following a stroke. Prosthetic Heart Valves: Practice Essentials, Background - Medscape Reson. Update my browser now. Currently the bileaflet valve, especially the St. Jude Medical valve (St. Jude Medical, St. Paul, MN), is the most commonly used mechanical valve around the world. An official website of the United States government. Int J Artif Organs. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Advancing the Technology of Bileaflet Mechanical Heart Valves, https://doi.org/10.1007/978-3-642-93691-3_12, Tax calculation will be finalised during checkout. %PDF-1.3 What do I need to do to maintain a healthy lifestyle with my replacement heart valve? Perioperative management of patients with prosthetic heart valves-A narrative review. J Thorac Cardiovasc Surg. ":Lk0\U~?y0)#!J Accessed April 20, 2021. p1`*&M33BP0+';~'ww.2c\b$1JM_@IQ B)&"-#i7Yw9I+aQlUhCF)}fs{OmknQ!9}:F-MrP[;su6$lph} 0f g)fSU$PP(\Ivf*DZ.g. Ann Thorac Surg. UA1E$ZGJ4 (W7- &,?im p A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. UL(JkZUnQJzUu)>3j&\(P`]SmZ f?t4_GI*LUyJ%Y{w. << /Length 5 0 R /Filter /FlateDecode >> Prosthetic heart valves are increasingly being used for dysfunctional native valves requiring intervention. ATS prosthetic valves AP series: echocardiographic evaluation. 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 . The ATS Open Pivot Heart Valve was first sold in international markets in 1992, and subsequently granted FDA clearance to sell in the United States in 2000. Atriasept Closure DeviceCardia, Inc.Eagan, MN, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., Lake Forrest, CA, Atrioventricular Valved Stent (AVS)Navigate Cardiac Structures, Inc., www.navigatecsi.com, Atrix-C Cervical Allograft Interbody SpacerXtant Medical, www.xtantmedical.com, Atrostim Phrenic Nerve StimulatorASTROTECH OYTampere, Finland, ATS 3f Enable Aortic BioprosthesisModel 6000ATS Medical, Inc.Lake Forest, CA, ATS Medical Open PivotAortic Valved GraftModel # XX denotes size502AGxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAortic, Model 501DA18Advanced Performance (AP)pyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 AorticModel # XX denotes size505DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP 360 MitralModel # XX denotes size505DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP AorticModel # XX denotes size501DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveAP MitralModel # XX denotes size501DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex AorticModel # XX denotes size503DAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveApex MitralModel # XX denotes size503DMxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveMitral, Model 500DM29Standard Valvepyrolytic carbonheart valveATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard AorticModel # XX denotes size500FAxxATS MedicalMinneapolis, M, ATS Medical Open PivotBileaflet Heart ValveStandard MitralModel # XX denotes size500DMxxATS MedicalMinneapolis, M, ATTRACTOR Screw17-4 SSPorex Surgical, Newnan, GA, Attune Flexible Annuloplasty RingSt. Even a simple teeth cleaning can introduce bacteria into your bloodstream, which can find their way to your heart valve and cause an infection. Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. Clipboard, Search History, and several other advanced features are temporarily unavailable. Heart Valves and Annuloplasty Rings More. The .gov means its official. Each sizer handle has a clear cylindrical ring that approximates the patients tissue annulus size for appropriate valve selection. Preoperatively, 17 patients (10%) were in New York Heart Association functional class II, 117 patients (66%) in class III, and 43 patients (24%) in class IV. Technical Support. By Posted when did harry styles dad passed away In mckayla adkins house how jeep positions itself into the market? MeSH This site needs JavaScript to work properly. 2006 Sep;82(3):847-52. doi: 10.1016/j.athoracsur.2006.04.042. Important Safety Information - Transcatheter Aortic Valve - Medtronic Careers. Heart Valves and Annuloplasty Rings More. Safety Topic / Subject Heart Valves and Annuloplasty Rings. J Am Heart Assoc. The integrative approach to assess prosthetic function includes 2-dimensional, colour Doppler . PMC Emery RW, Petersen RJ, Kersten TE, et al. recent deaths in greenfield,ca ; david custom knives . It's important that you follow your doctor's specific instructions and take your medication exactly as instructed. [Usefulness of magnetic resonance imaging for managing patients with prosthetic carbon valve in the mitral position]. In: Krian A, Matloff JM, Nicoloff DM, eds. A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for Aortic Valve and Ascending Aorta Replacement, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Cardiac Surgery Education, Innovation, and Evidence, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification.
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ats mechanical valve mri safety 2023