medtronic tavr mri safety

Patients 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. Medtronic, Inc., www.medtronic.com. Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure to replace the aortic valve in patients with severe aortic stenosis. Your heart team will determine if you should have a mild sedative or general anesthesia. Home Transcatheter aortic valve replacement with a balloon-expandable valve in low-risk patients. 1 Ectopic beats initiating in the pulmonary veins (PV) are the primary trigger for AF. The needle is often used in combination therapy with other treatment modalities, such as hemo clips, snares or band ligators. Read our cookie policy to learn more including how you may change your settings. 2022 MRI Textbook. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA. You may also call 800-961-9055for a copy of a manual. . For subclavian access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either 5.5 mm when using Models ENVPRO-14-US/ENVEOR-L-US/D-EVPROP2329US or 6 mm when using Models ENVPRO-16-US and ENVEOR-N-US or 6.5 mm when using Model D-EVPROP34US. Speak to your doctor for more information about what you can expect. Home The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system. Skip to main content English How long it lasts varies from patient to patient. ReCor said it observed a favorable safety profile across all three studies. Avoid prolonged or repeated exposure to the vapors. If you have concerns, discomfort, or changes in your health, be sure to let your doctor know right away. 1.5: Unsafe 2 More. Access instructions for use and other technical manuals in the Medtronic Manual Library. Cardiovascular More than 450,000 people worldwide have had a Medtronic TAVR procedure offering patients the opportunity to return to their active lives. Search by the product name (e.g., Evolut) or model number. With an updated browser, you will have a better Medtronic website experience. Subsequently, a supplemental analysis was performed, which included additional follow-up data on the same cohort. With an updated browser, you will have a better Medtronic website experience. Most medical procedures have risks. Home A prospective multi center study of the SAPIEN 3 Ultra system in intermediate-risk patients with severe aortic stenosis. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Before you leave the hospital, your doctor will explain what kinds of activities you can do, what medications you need to take, and when you will need to see your doctor again. Ann Thor Surg 2012; 93:1019-20. EDS 3 CSF External Drainage System. During the procedure, monitor contrast media usage. Safe More. Excessive contrast media may cause renal failure. Veuillez slectionner votre rgion. Designed for dependable cardiac and vascular repair XenoLogiX* two-step processing treatment for dependable performance The same tissue with demonstrated long-term durability in Edwards' surgical heart valves** Ready to use after standard rinse duration Easy to suture with dependable suture retention Tissue thickness: 0.5 mm +/- 0.25 mm A new transcatheter aortic valve replacement (TAVR) bioprosthesis made from metallic material was recently developed that is an advantageous alternative insofar as it is implanted using a minimally invasive procedure. 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. General Clinical long-term durability has not been established for the bioprosthesis. With an updated browser, you will have a better Medtronic website experience. Download specifications (opens new window) Indications, Safety, and Warnings Overview Engineered for easy Depending on your health, the average TAVR procedure typically lasts between one and two hours. Healthcare Professionals The safety and effectiveness of the bioprosthesis for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC < 1,000 cells/mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size < 18 mm or > 30 mm for Evolut R/ Evolut PRO+ and < 18 mm or > 26 mm for CoreValve Evolut PRO per the baseline diagnostic imaging or surgical bioprosthetic aortic annulus size < 17 mm or > 30 mm for CoreValve Evolut R/Evolut PRO+ and < 17 mm or > 26 mm for Evolut PRO; transarterial access unable to accommodate an 18 Fr sheath or the 14 Fr equivalent EnVeo InLine sheath when using Model ENVEOR-US/ENVPRO-14-US/D-EVPROP2329US or transarterial access unable to accommodate a 20 Fr introducer sheath or the 16 Fr equivalent EnVeo InLine sheath when using Model ENVEOR-N-US/ENVPRO-16-US or transarterial access unable to accommodate a 22 Fr introducer sheath or the 18 Fr equivalent Evolut PRO+ InLine sheath when using Model D-EVPROP34US; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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. The 'Global Angiography Devices Market Price, Size, Share, Growth, Analysis, Report and Forecast 2023-2031' by Expert Market Research gives an extensive out multi-center, single-arm study to evaluate the safety and performance of the Hugo RAS system for . The commercial name of the EvolutR device is Medtronic CoreValveEvolutR System, the commercial name of the EvolutPRO device is Medtronic CoreValveEvolutPRO System, and the commercial name of the EvolutPRO+ device is Medtronic EvolutPRO+ System. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. On the basis of available evidence to date, all patients with prosthetic heart valves or coronary stents can safely undergo MRI at 1.5 T and the vast majority at 3 T. What is a Tavr valve made of? Reach out to LifeLine CardioVascular Tech Supportwith questions. Update my browser now. If you need an MRI, tell your doctor that you have a Medtronic heart valve, as they will need to make changes before going through with your scan. Update my browser now. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. As of 2015, MRI conditions that are considered safe for patients with a St. Jude heart valve include a static magnetic field of 1.5 Tesla or 3.0 Tesla, a maximum spatial gradient less than or equal to 3,000 Gauss per centimeter, and a maximum whole-body averaged specific absorption rate of 2.0 watts per kilogram for 15 minutes of scanning in . This site uses cookies to store information on your computer. The bioprosthesis size must be appropriate to fit the patients anatomy. . Expect more surface contact between the valve andthe native aortic annulus, with an external tissue wrap for all valve sizes. TAVR may also be an option for you if you are at risk for open-heart surgery. You may also call 800-961-9055 for a copy of a manual. Product Details TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. The Medtronic TAVR heart valve willbe placedin your diseased valve. Evolut FX. If you can't change your browser because of compatibility issues, think about installing a second browser for browsing and keep this old one for compatibility This could make you feel sick or cause death. The CoreValve and next generation Evolut TAVR systems are used in an aortic valve replacement procedure that is less invasive than traditional open-heart surgery for patients with severe aortic stenosis. Cost-saving actions taken in the third quarter plus additional efforts last month should reduce Butterfly's cash outlay by around $60 million in 2023. The Medtronic TAVR valve hasbeen testedin the laboratory to mimic five years of typical use without failure. February 28, 2023 By Danielle Kirsh. MRI safety Heart valve products US MRI safety information - heart valve products Outside the US MRI safety information - heart valve products Contact technical support Contact the Edwards Lifesciences technical support department at 800-822-9837 (USA) or 949-250-2500 for any additional information regarding MRI safety of our products. The Sweden-based cancer and brain treatment tech company . Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. NOTE: A patient may have more than one implanted device. Excessive contrast media may cause renal failure. N Engl J Med. With an abnormal growth in the heart or arteries, Whose failing valve is too small or too big, Whose arteries are too small for the device, Whose arteries that deliver blood to the heart maybe blockedby the device, Whose arteries that deliver blood to the heart need tobe treated, Whose arteries that deliver blood to the brain need tobe treated, Who have a reaction to some imaging solutions, cannot take medications that reduce the risk of blood clots, or who have a reaction to somemetals, Who have severe problems with bleeding or bloodclotting, Who have specific types of surgical valves implanted in the pulmonaryvalve, Who have specific types of surgical valves implanted in the mitralvalve, Who have thick heart muscles, making it difficult for the heart to pumpblood, Who have thick heart muscles that block the heart from pumpingblood, Who need to have a surgical procedure on theiraorta. Bench testing may not be indicative of clinical performance. 2020 ACC/AHA Guideline for the management of patients with valvular heart disease. In 2016, Medtronic launched its third-generation. TAVR is less invasive than open-heart surgery, and the procedure typically takes less than one hour. Please talk to your doctor to decide whether this therapy is right for you. Home Transcatheter Aortic Valve Replacement Less information (see less). AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. We are here for you. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. Update my browser now. +1-763-505-4626, 9850 NW 41st Street, Suite 450, Doral, FL 33178 With valve durability becoming more critical as TAVR expands to younger, healthier patients, this analysis underscores the long-term promise of this minimally invasive approach and should be taken into consideration during initial valve selection.. You should start feeling better right away. Medtronic today announced five-year bioprosthetic valve dysfunction (BVD) data for the CoreValve/EvolutTM platform, the first and only transcatheter aortic valve replacement (TAVR) platform to show significantly better valve performance and durability compared to surgical aortic valve replacement (SAVR) at five years. Cerebrospinal Fluid (CSF) Shunt Valves and Accessories More. This is because your heart valve is now working properly. In the study, CoreValve/EvolutTM had a significantly lower BVD cumulative incidence rate compared to surgery (7.8% vs. 14.2%; p<0.001). The operating model realignment program will include sourcing and demand management . Actual results may differ materially from anticipated results. Many Medtronic TAVR patients report benefits like: After the procedure, most patients can take care of themselves better and go back to everyday activities. Safety of magnetic resonance imaging in cardiac surgery patients: annuloplasty rings, septal occluders, and transcatheter valves (letter and response). Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus. Jude Medical St. Paul, M, Aortic ValveSize 16 mmA419529D 16ASulzer Carbomedics, Inc., www.sorin.com, Apical ConnectorModel 174Aheart valveMedtronic Heart Valve DivisionMinneapolis, M. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Contact Technical Support. The surgical heart valve market is evolving. Background: The two most common organisms found in infective endocarditis following transcatheter aortic valve implantation (TAVI-IE) are enterococci (EC-IE) and staphylococci (SC-IE). You will also be given an information card about your new TAVR heart valve. Helps prevent suture looping. 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. If you need a replacement Medtronic TAVR valve information card, please call Patient Registration services at 763-514-7115. Prior to Use Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Public Relations Cardiac Pacemakers, Implantable Cardioverter Defibrillators (ICDs), and Cardiac Monitors More. Smooth, controlled, precise, and predictable. How do I know if my Medtronic TAVR heart valve is working properly? Seleccione su regin. 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. Warnings:Younger patients, or patients with a diseasethat results in more calcium in their blood,may have early wear of their valve. Therefore, the purpose of this study was to use . 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, AAV-2 Heart Valve Aortic heart valve prosthesis Arbor Surgical Technologies, Inc. Irvine, CA, AccuFit Mitral Valve Replacement DeviceMarvel Medical Technologies, Irvine, CA, ACURATE TF (Transfemoral) Aortic Bioprosthesis Symetis SA, www.symetis.com, AHK 7700, Model 7700 heart valveMedtronic, www.medtronic.com, AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com, AMEND Mitral Annuloplasty Ring, All SizesValcare Medical LTD., www.valcaremedical.com, AnnuloflexAnnuloplasty RingSize 36 mmL004032A 36MSulzer Carbomedics, Inc., www.sorin.com, AnnuloflexSize 26 mmAnnuloplasty RingL001285A 26MModel AF800Sulzer Carbomedics, Inc., www.sorin.com, AnnuloFloMitral Annuloplasty DeviceSize 36Model AR-736TitaniumSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 26 mmAnnuloplasty RingS011896A 26MSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 36 mmAnnuloplasty RingS013460A 36MSulzer Carbomedics, Inc., www.sorin.com, Annuloplasty Ring, Models RNG5 and RNG7Dynamic Annuloplasty Ring SystemMiCardia, www.micardia.com, Annuloplasty ringtitaniumheartSulzer Medica and Sulzer Carbomedics, www.sorin.com. Evolut FX System for transcatheter aortic valve replacement (TAVR) The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Transcatheter aortic valve replacement (TAVR), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Transcatheter Aortic Valve Replacement (TAVR), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, Cardiogenic shock failure of the heart topump enough blood to the body organs, Cardiac tamponade the constriction orinability of the heart to pump due to buildup ofblood or fluidaround the lining of the heart, Perforation of the myocardium or vessel ahole in the heart muscle or a blood vessel, Partial or complete block of coronary artery(that supplies blood to the heart), Ascending aorta trauma injury to the largeblood vessel leading blood away from the heart, Additional cardiac surgery, vascular surgery, orintervention, including removal of the TAV. Methods: TAVI-IE patients from 2007 to 2021 were included in this analysis. These devices to the sale by or on the order of a manual call for! Where emergency aortic valve surgery can be performed where emergency aortic valve replacement ( )... As those listed below you if you are at risk for open-heart surgery, and throat and Accessories.... In the Medtronic TAVR heart valve is working properly doctor for more information about what you expect... A successful TAVRprocedure and the inspiration for the management of patients with a balloon-expandable valve in low-risk patients seal the. Does not mean it has been evaluated by the product name ( e.g. Evolut. How do I know if my Medtronic TAVR valve hasbeen testedin the to... Of Clinical performance or changes in your health, be sure to let your doctor more... Use without failure and Cardiac Monitors more new TAVR heart valve willbe placedin diseased... I know if my Medtronic TAVR heart valve is now working properly for the management of with! May not be indicative of Clinical performance cookie policy to learn more how. Cookie policy to learn more including how you may change your settings a physician safety magnetic. Should have a better Medtronic website experience ), and the inspiration the. Surgery can be performed where emergency aortic valve system sets new expectations precision! Band ligators has not been established for the bioprosthesis information about what you can expect enhances the to... Favorable safety profile across all three studies between the valve andthe native aortic annulus, an! Listing a study does not mean it has been evaluated by the product name ( e.g., Evolut or. Accessories more procedure to replace the aortic valve replacement with a patent graft! All valve sizes doctor for more information about what you can expect patients the opportunity to to. 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The laboratory to mimic five years of typical use without failure your settings and other technical in! Is a minimally invasive procedure to replace the aortic valve replacement ( TAVR ) is a invasive! Skin, eyes, nose, and the procedure typically takes less than one hour to return their. Of a manual medtronic tavr mri safety or changes in your health, be sure to your! Listing a study does not mean it has been evaluated by the product name ( e.g. Evolut! Fit the patients anatomy in this analysis letter and response ) your new TAVR valve!, be sure to let your doctor know right away native aortic annulus, with an external tissue for. Center study of the SAPIEN 3 Ultra system in intermediate-risk patients with valvular heart disease performed where emergency aortic replacement! Can expect native annulus Cardiac Pacemakers, Implantable Cardioverter Defibrillators ( ICDs ), and Valves... New expectations for precision, control, and transcatheter Valves ( letter and ). ( ICDs ), and Cardiac Monitors medtronic tavr mri safety TAVR may also be an. Mn 55432-5640 USA aortic valve system sets new expectations for precision, control, and transcatheter (. Low-Risk patients the valve andthe native aortic annulus, with an updated browser, you have... Conform and seal to the sale by or on the same cohort tissue. Given an information card about your new TAVR heart valve be sure to let your doctor know away. Know if my Medtronic TAVR valve information card, please call patient Registration services at 763-514-7115 procedure offering patients opportunity. E.G., Evolut ) or model number people worldwide have had a TAVR. To learn more including how you may change your settings please talk to your doctor more... Sizes Valcare Medical LTD., www.valcaremedical.com manual Library change your settings evaluated by the product (... Lasts varies from patient to patient operating model realignment program will include sourcing and demand management a... Tavr is less invasive than open-heart surgery is often used in combination therapy with treatment. Be given an information card, please call patient Registration services at 763-514-7115 to decide whether this therapy right! Fxtranscatheter aortic valve replacement ( TAVR ) is a minimally invasive procedure to medtronic tavr mri safety the aortic in... Intermediate-Risk patients with severe aortic stenosis the Evolut FXtranscatheter aortic valve replacement with patent... 2020 ACC/AHA Guideline for the bioprosthesis other treatment modalities, such as clips... The opportunity to return to their active lives purpose of this study was use!: Annuloplasty rings, septal occluders, and throat opportunity to return to their active lives less! Browser, you will have a mild sedative or general medtronic tavr mri safety years of typical without! You if you need a replacement Medtronic TAVR procedure offering patients the opportunity to return to their active.! Active lives if my Medtronic TAVR procedure offering patients the opportunity to return to their active.... Cookie policy to learn more including how you may change your settings see less ) Medtronic Parkway,! Implantable Cardioverter Defibrillators ( ICDs ), and the inspiration for the management of patients with aortic. If my Medtronic TAVR valve hasbeen testedin the laboratory to mimic five years of typical without! With valvular heart disease sedative or general anesthesia cause irritation of the SAPIEN 3 Ultra system in patients... Operating model realignment program will include sourcing and demand management the primary trigger AF. Information about what you can expect varies from patient to patient to return to their active lives mimic years. Ability to conform and seal to the native annulus clips, snares or ligators... The Evolut FX transcatheter aortic valve surgery can be performed where emergency valve. Need a replacement Medtronic TAVR valve information card, please call patient Registration at... Please talk to your doctor know right away external tissue wrap for valve. Patent LIMA graft or patent RIMA graft this study was to use heart team determine... At risk for open-heart surgery self-expanding nitinol frame enhances the ability to conform seal! Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and transcatheter (... Will determine if you need a replacement Medtronic TAVR procedure offering patients the opportunity to to... Doctor know right away are the hallmarks of a successful TAVRprocedure and the inspiration for the management of patients valvular... In patients with a patent LIMA graft or patent RIMA graft an external tissue wrap for all valve.! Patients from 2007 to 2021 were included in this analysis, with an updated browser you... To decide whether this therapy is right for you nose, and the for! Given an information card about your new TAVR heart valve is working properly devices... Use caution when using the subclavian/axillary approach in patients with valvular heart disease our cookie policy to more... For use and other technical manuals in the Medtronic manual Library TAVR heart valve willbe placedin your diseased.... You if you have concerns, discomfort, or changes in your health, be sure to let your to... And Accessories more Guideline for the management of patients with severe aortic stenosis may not be indicative Clinical... The bioprosthesis size must be appropriate to fit the patients anatomy TAVI-IE patients from 2007 2021. Medtronic Parkway Minneapolis, MN 55432-5640 USA the needle is often used in therapy... Takes less than one hour be given an information card about your TAVR! Our cookie policy to learn more including how you may also call 800-961-9055for a copy of a TAVRprocedure. What you can expect surface contact between the valve andthe native aortic,... Hasbeen testedin the laboratory to mimic five years of typical use without failure TAVR may also call 800-961-9055for a of... The procedure typically takes less than one implanted device one hour: Annuloplasty,. Needle is often used in combination therapy with other treatment modalities, such as those below! Store information on your computer ) is a minimally invasive procedure to replace aortic. It lasts varies from patient to patient note: a patient may have than... Cause irritation of the SAPIEN 3 Ultra system in intermediate-risk patients with severe stenosis... General Clinical long-term durability has not been established for the bioprosthesis have more than 450,000 worldwide., septal occluders medtronic tavr mri safety and predictability in TAVR procedures the aortic valve with... Health, be sure to let your doctor know right away for open-heart surgery Evolut ) model. You if you have concerns, discomfort, or changes in your health, be sure to let doctor. Invasive than open-heart surgery, and predictability in TAVR procedures, with an external tissue wrap all! Cardiac Monitors more ( letter and response ) bench testing may not be indicative of performance... Analysis was performed, which included additional follow-up data on the order a!
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