ats mechanical valve mri safety

2010 May;31(5):1075-80. doi: 10.1002/jmri.22163. }qiKy{S,Mu;7#OWWMW|V^\zKltNe4kaKv?%9aB{\gfDSJk.nZ(zhz\ +o%beN`*''CXgk qhJi2?f-eg Van Nooten GJ, Caes F, Francois K, et al. Postoperative echocardiographic data revealed low mean pressure gradient as related to the valvular size. 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. Aortic and Mitral Valve Replacement 2011 May;29(2):229-36. doi: 10.1016/j.ccl.2011.01.007. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Object Status Conditional 6. Recovery time depends on many different things, including your overall physical condition before surgery. Premarket Approval (PMA). Would you like email updates of new search results? Bookshelf 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. 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. MRI at 1.5 T is also safe for patients who carry old mechanical prostheses such as the Pre-6000 Starr-Edwards caged-ball prosthesis (available from 1960 to 1964), including assessment of the heart itself (cardiovascular magnetic resonance [CMR]). 1999; 22:754-763. If I have a mechanical heart valve implanted, will I need to take medications after my surgery? It has a low profile bi-leaflet valve with a polyester sewing ring. Is it safe to have a magnetic resonance imaging (MRI) scan after heart valve replacement? Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Ann Card Anaesth. The site is secure. Previous reports have focused on the low rate of thromboembolic complications in the aortic position. 2001; 4(4):346-353. November 1999;22(11):754-763. For others, it may take longer to notice a change. Overall hospital mortality was 2.8% (5 patients). Before The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. Diagnostics (Basel). A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. Is it safe to have a magnetic resonance imaging (MRI) scan after heart valve replacement? J Am Soc Echocardiogr. J Heart Valve Dis. With tissue valves, the need for life-long blood-thinning medication is usually minimal. Ozeren M, DoGan OV, Dolgun A, Koyildirim E, Karapinar K, Ycel E. J Heart Valve Dis. SAFETY OF ST. JUDE MEDICAL VALVES AND ANNULOPLASTY RINGS . Ann Thorac Surg. Five early neurologic complications occurred: 3 transient cerebrovascular accidents and 2 strokes. Methods: Proven Graft Material The Hemashield*Woven Double Velour graftis made with a low-porosity graft material to improve hemostasis.6,7Excellent resorption rates facilitate healing.6The graft material also offers exceptional handling characteristics. official website and that any information you provide is encrypted A larger graft internal diameter minimizes stress on coronary anastomosis, and the rotatable valve allows for optimal leaflet positioning. MeSH FAQ. Copyright 2018 Hellenic Society of Cardiology. Disclaimer. Advanced Discussion (show/hide) References 2023 Springer Nature Switzerland AG. All patients were followed up by one cardiologist and underwent annual transthoracic echocardiographic examination. Be sure to tell your dentist or doctor you have a mechanical heart valve. Proven Graft Material Tell your doctor if you have dramatic, unexplained weight gain, fever, pain, or other symptoms. ]B&A]~i:QQD(X9&n({.:-B6JZTJ4S!`n,Jo;M'u)tGC{B@xxhC*^t(6 gJon8\d! This site needs JavaScript to work properly. Eat a low-salt diet if your doctor prescribes one for you. You and your doctor together will decide which option is best for you. Ann Thorac Surg. Mean follow-up was 48 +/- 34 months (range, 1 to 119). Criteria previously used for safety assessment of heart valve prostheses and expressed in terms of magnetic forces suggest the forces observed in this study are compatible with the safe use of these valves in magnetic resonance (MR) systems with static fields up to 4.7 T. J. Magn. 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. 2001 Sep;10(5):628-35. Such D, Symersky P, Tanis W, Mali WP, Leiner T, van Herwerden LA, Budde RP. (eds) Advancing the Technology of Bileaflet Mechanical Heart Valves. Clinical results of a large series of ATS valve implants. ATS Medical Open Pivot Bileaflet Heart Valve AP 360 Aortic Model # XX denotes size 505DAxx Can I have an x-ray after heart valve replacement? 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. Mosaic Bioprosthesis: Ten year Clinical Update. Emery RW, Petersen RJ, Kersten TE, et al. Prevalence and Evolution of Susceptibility-Weighted Imaging Lesions in Patients With Artificial Heart Valves. Accessibility recent deaths in greenfield,ca ; david custom knives . Download preview PDF. Echocardiographic gradients were proportional to valve size and did not significantly change over the follow-up period. The survival for postoperative thromboembolic . In vitro assessment of flow patterns and turbulence intensity in prosthetic heart valves using generalized phase-contrast MRI. PMC ATS Medical Open Pivot: . Chen CW, Tseng YH, Lin CC, Kao CC, Wong MY, Ting H, Huang YK. Ann Thorac Surg. Please enable it to take advantage of the complete set of features! sVUe:p+eeU6UfBdqC_5\a(#?n`pj4UpV_E+J1q!b$` E@,6{8^(}?hP%OJ!p M4#b@Za@ J& endstream endobj 37 0 obj <> endobj 38 0 obj <> endobj 39 0 obj <>stream Int J Artif Organs. Mechanical Valves: Tissue Valves: Annuloplasty Rings: xxA-101 or xxM-101 B10 . The site is secure. 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. {SY:;u?b- |`+O1EV2,6&KXfti0(yrNgFT(iIeiDGhQkn9Hdq13zFIqCX'ShBL1P Products 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. In: Krian A, Matloff JM, Nicoloff DM, eds. Open Pivot Standard Aortic Heart Valve The Open Pivot Standard Aortic Valve provides these additional features: Intra-annular valve with generous, compliant cuff for exceptional implantability Valve sizes ranging from 19 mm to 31 mm Open Pivot Standard Mitral Heart Valve The Open Pivot Standard Mitral Valve provides these additional features: Your use of the other site is subject to the terms of use and privacy statement on that site. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. medtronic open pivot heart valve mri safety. What do I need to do to maintain a healthy lifestyle with my replacement heart valve? 2010;139:1494-1500. If I have a tissue heart valve implanted, will I need to take any medications after my surgery? 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. Medtronic open pivot mechanical valves offer exceptional performance: The Open Pivot AP360 provides these additional features: The Open Pivot AP provides these additional features: The Open Pivot Standard Aortic Valve provides these additional features: The Open Pivot Standard Mitral Valve provides these additional features: A variety of accessories are available to quickly and easily select the optimal valve type, appropriate valve size, and ideal placement for valve positioning. The purpose of this retrospective study is to analyze the rate of midterm thromboembolic events and other valve-related complications when the ATS Open Pivot valve is implanted in the mitral position. There have been many mechanical valve prostheses developed and implanted clinically since the first implant of the ball valve. 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. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Unable to load your collection due to an error, Unable to load your delegates due to an error. Your doctor might put you on blood thinning medication while you're healing. March 1993;17(3):538-545. This study documented the ATS Medical prosthesis to be a valuable addition to the surgeon's armamentarium in the treatment of cardiac valvular disease. You just clicked a link to go to another website. Jamieson WR, Pelletier LC, Janusz MT, Chaitman BR, Tyers FO, Miyagishima RT. HHS Vulnerability Disclosure, Help Three late transient cerebrovascular ischemic accidents occurred at 3, 4, and 6 years, respectively. This newly developed valve has many outstanding features: open-pivot structure, wider orifice area, improved durability, reduced energy loss, and rotatable orifice. In this paper we report our early clinical investigation data with special regard to the AP series. morecambe fc owners medtronic open pivot heart valve mri safety. The ATS Medical valve is manufactured in two models: the standard model and the advanced performance (AP) model. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. LifeLine CardioVascular The AP series expands applications for the small aortic root or other situations where hemodynamics are critical. 2015 Sep;8(9):e003703. UL(JkZUnQJzUu)>3j&\(P`]SmZ f?t4_GI*LUyJ%Y{w. 2010 Jul;19(4):473-84. Central/Eastern Europe, Middle East & Africa, Supra-annular flanged cuff configuration for added flexibility, needle penetration, and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic valve replacement, Supra-annular compact cuff configuration for excellent suturability and conformability, Valve sizes ranging from 16 mm to 26 mm for aortic and mitral valve replacement, Intra-annular valve with generous, compliant cuff for exceptional implantability, Medtronic Open Pivot Sizer Kit includes AP Series and Standard Heart Valve sizers, a bendable holder handle, and a sterilization tray, Mitral Hex End Rotators and Holder provide additional length and flexibility when needed for rotation of mitral valves. Update my browser now. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Cardiac computed tomography (CT) and magnetic resonance imaging (MRI) have emerged as new potential imaging modalities for valve prostheses. Previous reports have focused on the low rate of thromboembolic complications in the aortic position. Cocchia R, Chianese S, Lombardi G, Romano L, Capone V, Amitrano L, Bennato R, Ranieri B, Russo G, Mauro C, Bossone E. Clin Pract. doi: 10.1161/JAHA.119.012814. Patient Booklet: Medtronic Surgical Valve Replacement, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. We present an overview of the possibilities and pitfalls of CT and MRI for PHV assessment based on a systematic literature review of all experimental and patient studies. 2022 Aug 29;12(5):686-691. doi: 10.3390/clinpract12050071. MeSH Multimodality Imaging Assessment of Prosthetic Heart Valves. The initial experience with the ATS Medical mechanical cardiac valve prosthesis. All replacement heart valves are completely safe with x-ray exams. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. J Thorac Cardiovasc Surg. Long term results of mitral valve replacement with preservation of the posterior leaflet. Federal government websites often end in .gov or .mil. Provided by the Springer Nature SharedIt content-sharing initiative, Over 10 million scientific documents at your fingertips. 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 ]. heart valve ATS Medical Minneapolis, M. 1.5: Conditional 5 More. J Vasc Surg. This medication helps prevent the formation of blood clots, which are a serious health risk. The mechanical heart valves are contraindicated or difficult to apply in patients unable to . Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . Before and after Endovascular Aortic Repair in the Same Patients with Aortic Dissection: A Cohort Study of Four-Dimensional Phase-Contrast Magnetic Resonance Imaging. . {5J,gLH o6"P;=^1!CNjpj }dA93 Hp3#EDY$L(-]ET! The ATS Medical Open Pivot mechanical heart valve was introduced in 1992. With a mechanical valve, your doctor will prescribe blood-thinning (anticoagulant) medication you'll take for the rest of your life. Product Type Product Name REF* MRI Information Mechanical Valve Carbomedics Prosthetic Heart Valve (CPHV) A5-0XX M7-0XX R5-0XX S5-0XX A1-0XX M2-0XX F7-0XX The https:// ensures that you are connecting to the and transmitted securely. %PDF-1.3 Typically, recovery takes at least eight weeks and up to 12 weeks. 8$ESTd8]c"[ 6K.mKI05gveIUQ&,Rf|TZO"\ |3 2004 Mar;13(2):231-238. %PDF-1.5 % The aortic valve tissue. official website and that any information you provide is encrypted Reson. MeSH Easy Implantability With no tapers or pleats, the Medtronic Open Pivot Aortic Valved Graft allows for easy anastomosis anywhere on the graft. heart valve ATS Medical Minneapolis, M. 1.5: Conditional 5 More. Careers. SJM REGENT MECHANICAL HEART VALVE. 4 0 obj The carbon orifice used in the design corresponds to a standard valve three millimeters larger, hence a 22 mm AP aortic valve is the same in GOA as a 25 mm standard valve. single family homes for rent in hamden, ct recent deaths in greenfield,ca Menu . Koito H, Imai Y, Suzuki J, Ohkubo N, Nakamura C, Takahashi H, Iwasaka T, Inada M. Cardiol Clin. J Heart Valve Dis. J Heart Valve Dis. HHS Vulnerability Disclosure, Help 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 Circ Cardiovasc Imaging. PMC Unlike other bileaflet valves, which use cavity pivots, the Medtronic Open Pivotaortic valved graft (AVG) has no recesses or cavities in the pivot area where thrombogenesis can occur.1,2This allows for continuous passive washing and gentle treatment of blood cells, resulting in low levels of hemolysis and thromboembolic events.1,3, In-vivo studies demonstrate excellent hemodynamics.3-5. Ann Thorac Surg. Broadly, they can be classified into three categories: mechanical heart valves, bioprosthetic valves, and homograft. Ann Thorac Cardiovasc Surg. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Accessed April 20, 2021. This process is experimental and the keywords may be updated as the learning algorithm improves. [kq|XJGzc9H ,s>1B/e j. Severe Stenosis of Mitral Bioprosthetic Valve Thrombosis in a Patient with HCV-Related Cirrhosis and Duodenal Variceal Bleeding: The Deadly Triad. This site needs JavaScript to work properly. Update my browser now. 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. Unauthorized use of these marks is strictly prohibited. Object Category Heart Valves and Annuloplasty Rings. Table # Referenced products MR Safety Table 1 Solo Smart Carbomedics Annuloflex MR Safe Table 2a Carbomedics Prosthetic Heart Valve (CPHV) . official website and that any information you provide is encrypted Emery RW, Petersen RJ, Kersten TE, et al. It is possible that some of the products on the other site are not approved in your region or country. With an updated browser, you will have a better Medtronic website experience. Bookshelf J Am Heart Assoc. 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. Tell your doctor if you make any lifestyle changes. The initial United States experience with the ATS mechanical cardiac valve prosthesis. Data represent 724 total patient-years. Bethesda, MD 20894, Web Policies Before These keywords were added by machine and not by the authors. With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Medtronic, Inc. 2007. 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 Medical Open Pivot mitral valve demonstrates low rates of bleeding, thromboembolic, and other valve-related complications. ATS prosthetic valves AP series: echocardiographic evaluation. [The best of valvular heart disease in 2006]. x]]6r}`D#sIJ==>X~$k=f}.>$VNL,n}~+*+V0O4+? 26 ATS Medical Open Pivot Bileaet Aortic 501DA18 18 Pyrolytic carbon Teon ATS Medical Inc., Minneapolis, MN 27 SJM Reagent Valve Bileaet Aortic 25AGN-751-IDE 25 Polyester Mechanical Heart Valve St. Jude Medical Inc., St. Paul, MN 28 St. Jude Medical Mechanical Heart valve Bileaet Aortic 25AJ-501 25 Polyester St. Jude Medical Inc . With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Will a mechanical heart valve set off airport security? Quant Imaging Med Surg. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. There are advantages and disadvantages with either choice. and transmitted securely. Seventy-four patients (42%) were in chronic atrial fibrillation. If you continue, you may go to a site run by someone else. Clipboard, Search History, and several other advanced features are temporarily unavailable. 8600 Rockville Pike % kfdSL`FgW. The On-X aortic heart valve is the only mechanical valve FDA approved and clinically proven to be safer with less anticoagulation. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. ":Lk0\U~?y0)#!J Home U.S. Food & Drug Administration. ;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 Bethesda, MD 20894, Web Policies Aortic valve replacement (AVR) was conducted in 152 patients (39 with coronary bypass) and mitral replacement (MVR) in 72 patients (18 with coronary bypass). Epub 2019 Aug 5. 3: . Be sure to tell your dentist or doctor you have a tissue heart valve. PubMedGoogle Scholar, Clinic for Thoracic and Cardiovascular Surgery, Heart Center Duisburg, Gerrickstr. The paper refers to the safety of MRI in patients with prosthetic heart valves or coronary stents. Perioperative management of patients with prosthetic heart valves-A narrative review. What are complications with heart valve replacement surgery? 1996;10(8):660-665. (1998). Etiologies included degenerative disease (56%), rheumatic disease (38%), and endocarditis (6%). Heart Valves Surgical Unable to display preview. Eleven-year single-center experience with the ATS Open Pivot Bileaflet heart valve. HHS Vulnerability Disclosure, Help CONTRAINDICATIONS 2006 Sep;82(3):847-52. doi: 10.1016/j.athoracsur.2006.04.042. The .gov means its official. March 2004;13(2):231-238. ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. Background: This device may also be used to replace a previously implanted aortic prosthetic heart valve. Five-year evaluation of the Carpentier-Edwards porcine bioprosthesis. ATS Medical Open Pivot Valve: Mechanical bileaflet . Steinkopff. 21, D-47137, Duisburg, Germany, 511 So Lucerne Blvd, Los Angeles, CA, 90020, USA, Cardiac Surgical Associates P.A., 920 East 28th Street, # 420, Minneapolis, MN, 55407, USA, 1998 Dr. Dietrich Steikopff Verlag GmbH & Co. KG, Darmstadt, Parravicini, R. et al. % Discuss your personal situation with your doctor to ensure you understand the risks, benefits, and possible complications associated with heart valve replacement surgery. 1996(10):660-665. Clipboard, Search History, and several other advanced features are temporarily unavailable. !f!9x~+i~P=_/rQGl7zkJz!e rYj*" ~pp1pn;jTn*M[*HI f,/Afd. The AP series expands applications for the small aortic root or other situations where hemodynamics are critical. The ATS Medical valve is manufactured in two models: the standard model and the advanced performance (AP) model. Disclaimer. Biocor Valve Mitral Size 35-mm Model B10-35M heart valve St. Jude Medical, Inc., www.sjm.com Surgical Heart Valve Repair and Replacement Please enable it to take advantage of the complete set of features! Disclaimer. It allows both morphologic and haemodynamic assessment according to the current guidelines [1,2]. September 1993;106(3):427-433. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. You may need other medications, depending on your overall health and the particular nature of your valve disease. Federal government websites often end in .gov or .mil. Eur J Cardiothorac Surg. 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. Products Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. How soon after surgery can I expect to see results? and transmitted securely. Emery RW, Krogh CC, Jones DJ, et al. 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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