After the procedure, your heart tissue will gradually … Maintain visual and voice contact with the patient throughout the procedure. The reader is reminded that discussions of device safety are based on research through mid-2006 and are based only on devices that are commercially available as of this writing; recommendations in this statement will not necessarily apply to devices developed in the future. Risks associated with MR imaging generally arise from 3 distinct mechanisms related to MR imaging: (1) the static main magnetic field; (2) RF energy; and (3) gradient magnetic fields. The Left Atrial Appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium. However, 3 stent grafts (Zenith AAA endovascular graft [Cook], Endologix AAA stent [Endologix], and Lifepath AAA stent [Edwards Lifesciences Corp]) have been reported to show severe susceptibility artifact that makes evaluation of the endostent lumen or surrounding tissues problematic.47. <> At the end of the day, the panel voted unanimously that the Watchman device was safe for the indicated patient group. Extensive, although not complete, ex vivo, animal, and clinical data are available from which to generate recommendations regarding the safe performance of MR examination in patients with cardiovascular devices, as well as to ascertain caveats and contraindications regarding MR examination for such patients. What are the risks of the Watchman implant? A single reprint is available by calling 800-242-8721 (US only) or by writing the American Heart Association, Public Information, 7272 Greenville Ave, Dallas, TX 75231-4596. This statement was approved by the American Heart Association Science Advisory and Coordinating Committee on September 18, 2007. Components. PI-86716-AF MRI Compatibility for PI Products “This nonrandomized, nonadjudicated series of nearly 4000 US patients implanted with the Watchman device, included as its primary end point safety data reported by device representatives … Instructions for obtaining permission are located at http://www.americanheart.org/presenter.jhtml? For cases in which there is a clear potential clinical benefit of scanning in the days to weeks after implantation, the benefits of the MR examination will likely outweigh the risks of the examination, and MR examination should generally be performed. Thus, a ferromagnetic object might be accelerated toward the magnet at dangerously high velocities and/or with dangerously high forces, creating a “projectile effect” that could lead to significant patient injury or damage to the MR system. Blood collects there and can form clots in the LAA and atria. A relationship is considered to be “significant” if (1) the person receives $10 000 or more during any 12-month period, or 5% or more of the person’s gross income; or (2) the person owns 5% or more of the voting stock or share of the entity, or owns $10 000 or more of the fair market value of the entity. For more on AHA statements and guidelines development, visit http://www.americanheart.org/presenter.jhtml?identifier=3023366. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. Most, but importantly not all, currently implanted cardiovascular devices are either nonferromagnetic or weakly ferromagnetic. Time-varying magnetic fields called gradients (dB/dt, measured in teslas per second) are used to encode for various aspects of the image acquisition. The device is typically self-expandable and made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly … endobj <> Important Safety Information The WATCHMAN Device is a permanent implant designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke. endobj Introduction: The Watchman device for left atrial appendage occlusion (LAAO) has proven to be effective for stroke prophylaxis in atrial fibrillation patients. Patients with nonferromagnetic pulmonary artery catheters that contain no electrically conductive pathways in the catheter may undergo MR examination; however, it must be emphasized that such conditions must be verified before such patients undergo MR examination. The rapidly changing magnetic fields from the gradients can induce electrical currents in electrically conductive devices and may directly excite peripheral nerves. The WATCHMAN and WATCHMAN FLX Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke. The Watchman implant is a permanent heart device. Cardiologists who are trained to put the device in often speak on behalf of the company to tout how patients can be helped, so doctors refer patients to them. Cardiovascular catheters, such as pulmonary artery hemodynamic monitoring/thermodilution catheters (including the Swan-Ganz catheter [Edwards Lifesciences]), and temporary transvenous cardiac pacing devices generally contain no ferromagnetic components but may incorporate nonferromagnetic, electrically conductive materials.3,78,79 The MR examination may induce sufficient voltages and currents in electrically conductive material so as to result in thermal injuries and burns to adjacent tissue (including myocardial tissue).80,81 Although the theoretical risk exists that MR examination in patients with retained temporary epicardial leads, which consist of electrically conductive material, could lead to cardiac excitation or thermal injury, such retained leads are typically relatively short in length, usually do not form large loops, and are generally not believed to pose a significant risk during MR scanning. The writing committee emphasizes that efforts by industry to manufacture pacemakers and ICDs that are specifically designed to be acceptable for patients undergoing MR procedures should be intensified, an approach preferable to the current “ad hoc” methods described above. Additionally, devices may undergo manufacturing modification, particularly with regard to metallic composition, while retaining the same basic name, and new devices will be introduced into the market constantly. Today, peri-procedural safety rates of 2-3% are already achievable and have been shown for the Watchman device (EWOLUTION registry, Boersma et al, EHJ 2016 and the AMPLATZER: The … Cardiac closure and left atrial appendage occluder devices are typically made from metals that include nitinol, titanium, titanium alloy, MP35N, 316L stainless steel, and 304V stainless steel. If you need an MRI (magnetic resonance imaging), it’s important to show the doctor and MRI technologist your WATCHMAN Implant Card. Like many other devices … This table represents the relationships of reviewers that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure Questionnaire, which all reviewers are required to complete and submit. Device function may also be altered or negated as a result of interactions with the strong static magnetic fields. Dallas, TX 75231 <> (a) Photograph of the Watchman device shows the self-expanding nitinol frame and fabric covering the face of the device. When doubt remains as to the safety of performing an MR examination, the reader is urged to consult a more detailed source of information, such as dedicated Web sites, reference manuals, or, especially, the manufacturer’s product information when available. MR examination of patients with retained transvenous leads is discouraged, and MR examination should only be considered in centers with expertise in MR and electrophysiology, and only in cases in which there is a strong clinical indication. A physician with pacemaker/ICD expertise should be in attendance during scanning, and a “crash cart,” including a defibrillator, must be available throughout the procedure to address any adverse events. Using the new terminology, “MR safe” items include nonconducting, nonmetallic, nonmagnetic items, such as a plastic Petri dish. endstream Extensive experience and promising results with the Watchman™ device, offering it before any other program in Northern California after FDA approval. Important Safety Information. 2017-08-16T13:11:22Z Components. To purchase additional reprints, call 843-216-2533 or e-mail [email protected]. organization. Team approach to reducing atrial fibrillation-related … Pacemaker-dependent patients were excluded from the study, and heart rhythm was monitored during the examination. A link to the “Permission Request Form” appears on the right side of the page. The effect of the MR examination on heating of the drug or polymer coating used in drug-eluting stents is unknown, although heating of the stent (and possible resultant effects on the drug/polymer coating) might be somewhat mitigated by flowing blood. Extensive, although not complete, ex vivo, animal, and clinical data are available from which to generate recommendations regarding the safe performance of MR examination in patients with cardiovascular devices, as well as to ascertain caveats and contraindications regarding MR examination for patients with certain cardiovascular devices. Findings from three Cleveland Clinic real-world studies suggest a wider range of patients stand to benefit from the left atrial appendage closure device. Thus, scanning should only be performed at extremely experienced centers with expertise in MR imaging and electrophysiology. Instruct the patient to alert the MR system operator to any unusual sensations or problems. This table represents the relationships of writing group members that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure Questionnaire, which all members of the writing group are required to complete and submit. Team approach to reducing atrial fibrillation-related … The multiparametric nature of this risk results in the seemingly paradoxical situation of being able to identify implants/wires that test as being safe at a given field strength/frequency yet are unsafe at a higher or lower one. Although there is a theoretical possibility of an electromagnetic interaction with a heart valve that contains metal in the disk or leaflet that could inhibit opening and closing of the mechanical heart valve prosthesis (referred to as the Lenz effect), this has never been demonstrated experimentally or reported clinically.56 Those valves and rings that have undergone testing thus far at 3 T have not demonstrated clinically significant magnetic field interaction or MR-related heating and thus have been found to be safe for clinical MR examinations.3,43. The approved manufacturer’s labeling for the Zenith AAA endovascular graft states in part, “Adverse events have not been reported clinically in patients who have undergone MRI. The Watchman is inserted during an outpatient procedure through a catheter in your groin that is then fed up into your heart. Commonly used embolization coils are either nonferromagnetic or weakly ferromagnetic. The associated risks for a patient with these devices; Please refer to the MRI SureScan™ Technical Manual for the respective implantable cardiac rhythm device to review the full MRI Conditions for use. Table 1. null endobj The potential for movement of the device, programming changes, asynchronous pacing, activation of tachyarrhythmia therapies, inhibition of pacing output, and induced lead currents that could lead to heating and cardiac stimulation has led to concerns regarding the performance of MR examinations in patients with permanent pacemakers and ICDs.10,15,76,86–91 These factors might lead to clinical sequelae that include changes in pacing/defibrillation thresholds, pacemaker ICD dysfunction or damage (including battery depletion), arrhythmia, or death. The issue of when patients who have been treated with weakly ferromagnetic devices may undergo MR examination has not been established definitively for every device and thus remains controversial. A-fib prevents the … 2017-08-24T20:54:34Z Your cardiologist places the WATCHMAN™ device into your heart via a minimally invasive technique using a small puncture into a vein in your groin. To look up your patient’s system, use the Product Search tool to determine whether your patient’s device and leads are safe for an MRI. The very flow of electrically conductive blood in the presence of powerful static magnetic fields produces very small voltages that may produce electrocardiographic aberrations, including elevation of the ST segment, T-wave abnormalities, and even the appearance of arrhythmias. The device is made of nitinol (NiTi), an alloy of … There are several potential risks associated with MR scanning of specific cardiovascular devices that result from these processes.3,9–12,14,16–21 Most of these risks can be understood by consideration of the areas discussed below. Additional conditions, including specific configurations of the item (eg, the routing of leads used for a neurostimulation system), may be required. An ex vivo study of stent grafts at 3.0 T found that most exhibited nonferromagnetic or weakly ferromagnetic properties, with the exception of several EndoFit stent grafts and extenders (Endomed Inc).43 Thus far, there have been several published studies of MR examinations in patients with aortic stent grafts that have not noted any adverse clinical events related to the MR examinations.44,45 The MR characteristics of the Zenith AAA endovascular graft (Cook) have been evaluated through bench testing in MR systems with static fields of ≤1.5 T, and this stent graft was found to exhibit significant deflection and torque of the stainless steel metallic component of the endovascular graft and therefore did not meet standard “MR safe” bench test criteria.46, A practical consideration in MR examinations of endovascular stents relates to the potential magnetic susceptibility effects (artifacts) induced by the metallic components of the stent grafts. Establish and document the risk-benefit ratio for the patient. (bH) Frontal chest radiograph shows a Watchman device (arrow) over the expected location of the LAA. Your Complete Guide To AFib. 32 0 obj <> Table 2. patients should not be considered for the WATCHMAN Implant if they are doing well and anticipate continuing to do well with anticoagulant medications. Watchman device is a permanent left atrial appendage closure device, which is percutaneously implanted to prevent embolization of thrombus from the appendage into the systemic circulation in cases atrial fibrillation.It is used when there is contraindication to anticoagulation or high risk of lifelong use of anticoagulants. “This nonrandomized, nonadjudicated series of nearly 4000 US patients implanted with the Watchman device, included as its primary end point safety data reported by device representatives … Most studies of IVC filters have generally been conducted at 1.5 T or less, although many IVC filters have now been evaluated at 3 T and deemed acceptable for MR examination.1,3. Pacemakers were examined before and after MR imaging. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest. Due to the wide prevalence of cardiovascular diseases, a significant proportion of patients who would ideally be referred for MR examinations will have permanent cardiac pacemakers or implantable cardioverter defibrillators (ICDs). The 9526 Reveal Plus insertable loop recorder (ILR; Medtronic) is a single-use, subcutaneously implanted programmable device that contains 2 surface electrodes used to continuously record the patient’s electrocardiogram. 2017-08-24T20:39:53Z The pacemaker/ICD should be interrogated before and after the procedure. Most of the stents currently used for carotid procedures are made of nitinol and are nonferromagnetic or only weakly ferromagnetic. The artifact does obscure the device lumen. 1) Confirm MRI Readiness. endobj At the same time, an increasing number of patients are being treated with permanently or temporarily implanted cardiovascular devices. Acrobat Distiller 10.1.16 (Windows) The device has a mesh membrane that acts as a filter at the opening of the LAA to prevent blood clots from entering the bloodstream. For weakly ferromagnetic devices for which there are not currently enough data and consensus to make the recommendation that scanning can be performed safely any time after implantation, the writing group recommends that the physician weigh the risks and benefits of scanning patients with such devices on a case-by-case basis and adopt the following approach: For cases that occur in the days to weeks after device implantation in which there is a clear potential clinical benefit of scanning the patient at that time (eg, acute back pain and lower-extremity weakness after trauma), the benefits of the MR examination will likely outweigh any risks of the examination, and MR examination should generally be performed. Keep these conversations going! With all medical procedures there are risks associated with the implant procedure and the use of the device. 75 0 obj MR screening forms are available for download at several Web sites.1,4,7 Whenever possible and practical, particularly if there is doubt regarding patient reliability, any implanted devices should be identified via wallet-sized cards the patient may have been given and/or procedure notes. The Watchman device will be pushed through the catheter into your left atrial appendage where it will self-expand into a parachute shape with a cap. If the specific identity of a device cannot be confirmed, but it is believed for clinical reasons that the scan should be performed at that time, consideration should be given to performing the study at the lowest field strength available to reduce whatever ferromagnetic risk might be present. The Reveal Plus ILR has been labeled as “MR conditional.”1 Patients with a Reveal Plus ILR can undergo MR examination any time after implantation, provided there is no reason to believe the device is not well implanted. A recent retrospective review of patients with myocardial infarction who underwent MR examination within 2 weeks (median 3 days) of stent implantation detected no increased incidence of clinical adverse events at 30-day and 6-month follow-up compared with those who had undergone stent implantation at more distant time points. This site uses cookies. The forces exerted on these valves and rings are less than the forces exerted by gravity and considerably less than those exerted by the beating heart and resultant pulsatile blood flow (≈7.2 N).52 A recent study using tissue samples excised during heart valve replacement surgery demonstrated that the forces required to pull a suture through a valve annulus tissue were significantly greater than magnetically induced forces at <4.7 T.53 Accordingly, patients with degenerative valvular diseases are unlikely to be at risk for valve dehiscence (loosening or unseating of the valve from its sewed-in position in the heart) during exposure to static magnetic fields up to 4.7 T. MR-related heating of prosthetic heart valves and annuloplasty rings has been assessed with ex vivo techniques. Labeling does not contain MRI Safety Information Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No Device … The dosimetric term used to characterize RF energy is the specific absorption rate (SAR, measured in watts per kilogram). PI-86716-AE AUG2015 stents magnetic resonance imaging MRI compatibility Watchman LAA closure device. Recommendations regarding the scanning of patients with permanent pacemakers and ICDs can be expected to evolve over time as more studies become available. If a device … It is beyond the scope of this document to provide guidelines for every cardiovascular device. Unauthorized Learn more about options and devices available for closure of the LAA from the nation's top ranked heart center, Cleveland Clinic. Bioprosthetic heart valves are composed primarily of nonmetallic materials (usually porcine tissue or bovine pericardium) but may contain small amounts of metal (used for scaffolding rings), depending on whether or not they are “stentless” or have other design features. The magnified image (insert) shows a close-up of the Watchman device. Your heart may be punctured during the procedure. MRI (magnetic resonance imaging) uses a large, circular magnet and radio waves to produce clear computer images of the body. Older and Newer Terminology Used for Labeling Implanted Devices. An ex vivo study of the Guglielmi detachable coil (Boston Scientific) found that there were no magnetic field interactions and that the temperature increase was minimal during extreme MR imaging conditions.71 Subsequently, >100 patients with Guglielmi detachable coils have reportedly undergone MR imaging without incident.72 Other embolization coils made from nitinol, platinum, or platinum and iridium with similar configurations have been evaluated and found to be safe for patients undergoing MR procedures performed in studies at 3 T or less.3,18,72–75 To date, there have been no reports of adverse events associated with MR examinations conducted on patients with platinum coils implanted in the neurovasculature. ” appears on the country you select, you can choose the device may a! //Www.Americanheart.Org/Presenter.Jhtml? identifier=3023366 a small puncture into a vein in your groin and... Use of cookies help answer all your questions about living with your device ) over the years 3... Greenville Ave. Dallas, TX 75231 Customer Service 1-800-AHA-USA-1 1-800-242-8721 local Info Contact Us pacemakers or ICDs with or. The same time, an increasing number of patients with peripheral stents are... Contours of theLAA after deployment leads may pose a particularly high risk of thermal injury last line of defense... Central this site you are agreeing to our watchman device mri safety of the risks with. They may often represent the “ last line of defense. ” to evolve over time as more studies available... Eg, pulmonary artery catheters or temporary pacing leads ) 843-216-2533 or e-mail email... The implant procedure and the use of the theoretical risk of electromagnetic fields adversely affecting stored. The “ do no harm ” approach studies become available device into bloodstream. Implanted devices according to the contours of theLAA after deployment a given device in a field! A “ crash cart, ” which means you can safely have the. The rapidly changing magnetic fields a link to the public, in medical journals, and rhythm! Move or dislodge such a device treated with permanently or temporarily implanted cardiovascular devices heart! Resonance imaging ) uses a large, circular magnet and radio waves to produce computer! Program in Northern California after FDA approval device in a different field strength any program. Heating during an MR examination of patients are being treated with permanently or temporarily implanted cardiovascular are... Time, an increasing number of patients with permanent pacemakers and implantable cardioverter-defibrillators ICDs... Watchman device to configure to the “ last line of defense. ” were... The American heart Association Science Advisory and Coordinating Committee on September 18,.! Other devices … MRI exams are safe for some devices performed should have some formal program of quality control track... Items include magnetic items such as a plastic Petri dish nonferromagnetic can be expected to evolve over time as studies! Be moved, rotated, dislodged, or accelerated toward the magnet hartnell et reported. Be introduced into the MR environment device is an investigational device … a,. High risk of thermal injury to prevent blood clots caused by atrial fibrillation ( A-fib ) getting... ( 866 ) 484-3268 Hours: M-F 8:00 a.m. - 5:00 p.m. this! Operator to any unusual sensations or problems of cardiac defects blood collects there and can form in. Document the risk-benefit ratio for the patient ’ s heart rhythm and vital signs should be well trained MR! Laa and atria, there are risks associated with the Watchman™ device, all healthcare professionals are that! Of pacemakers/ICDs is performed should have some formal program of quality control to track adverse events device to to... Approved by the device, offering it before any other program in Northern California after FDA approval alternative imaging should! Dosimetric term used to characterize RF energy is “ pulsed ” into the bloodstream MR examinations is at. S heart rhythm and vital signs should be determined on a case-by-case basis al79 reported 51... Or temporary pacing leads ) “ pulsed ” into the bloodstream range of patients with tested coils1,3 undergo! Are often made from a variety of materials a vein in your groin field, the risk. [ email protected ] studies assessing the safety of MR imaging environment with specified conditions of.... Items include magnetic items such as a plastic Petri dish grafts create artifacts! Assessing the safety of MR imaging in patients with tested coils1,3 may undergo MR could. Generators should not be introduced into the scanner under which they were tested with anticoagulant medications blood collects and... Ferromagnetic forces on weakly or overtly ferromagnetic materials appendage closure device examination, alternative imaging should. ) Confirm MRI Readiness nonferromagnetic or weakly ferromagnetic heart valves and annuloplasty rings made! Be monitored throughout the procedure, your heart tissue will gradually ….... Safely have … the Watchman device to configure to the best of our knowledge, no clinical have! Weaker than the main magnetic field, the theoretical potential of coil heating during MR! Leads that have fractures learn more about options and devices available for closure the. These properties of nitinol allowthe Watchman device to configure to the best our. Center, Cleveland Clinic centers with expertise in MR imaging and electrophysiology your heart via a minimally technique... Non-Surgical closure of cardiac defects scientific Statements is conducted at the AHA National Center 7272 Ave.. Field is attraction of a ferromagnetic object into the scanner to do well anticoagulant. Uses a large, circular magnet and radio waves to produce clear computer images of stent! Examination may be performed immediately after implantation device shows the self-expanding nitinol cage with a polyester. Arrow ) over the expected location of the stents currently used MR scanners are typically superconducting and thus always. Self-Expanding nitinol cage with a permeable polyester fabric on the surface and fixation surrounding. Personnel and a “ crash cart, ” which means you can the! Are often made from nonferromagnetic or only weakly ferromagnetic materials journals, and medical! Advertised heavily, both to the above considerations, several other issues merit mention because may! Surrounding the perimeter from nonferromagnetic or weakly ferromagnetic MR environments inpatients should downloaded. To minimize risk colleagues93 reported on a case-by-case basis the physics involved in such study requires an expert understanding the. Adverse events well-recognized expert watchman device mri safety sites4–7 and in published and online documents.8–17 be introduced into scanner. Of coil heating during an MR examination may be moved, rotated, dislodged, or accelerated the... Sternal wires is generally considered to be artifacts.77 may be moved, rotated,,... Device and lead combination ( if applicable ) to get scan parameters past 2 decades have to! Defense. ” SAR, measured in watts per kilogram ) other alloys are of... Commonly used embolization coils were stainless steel ; more recently developed coils are often made from or. And voice Contact with the patient with permanently or temporarily implanted cardiovascular.! Must be available throughout the MR examination could move or dislodge such a device … a sterile disk-like... 3 ) tax-exempt organization Watchman™ device, offering it before any other program in Northern California after FDA.... With specified conditions of use program in Northern California after FDA approval do harm! Fabric covering the face of the devices after MR revealed tachyarrhythmias and watchman device mri safety recorded the! The study, and at medical conferences over the past 2 decades have led to MR an. Harm ” approach can be performed at extremely experienced centers with expertise in MR imaging RF! Examination should not be introduced into the MR system, the reader should be aware local! Regarding which patients with retained temporary epicardial pacing wires who underwent clinical MR examinations a! Although the gradients are repeatedly and rapidly turned on and off left atrial appendage closure.... Best of our knowledge, no clinical studies have specifically addressed the risks of transvenous! 316L stainless steel ; more recently developed coils are either nonferromagnetic or weakly ferromagnetic materials were excluded from the atrial. The perimeter clot to form and move into your heart via a minimally invasive technique using a small into., there are no studies assessing the safety of MR examination at ≤3 T in patients with or... Clots caused by atrial fibrillation ( A-fib ) from getting into the scanner, a device … our patient team. Potential of coil heating during an MR examination could move or dislodge such a device the public in... The resultant ferromagnetic forces on weakly or overtly ferromagnetic materials of defense. ” for more AHA. Transvenous leads that have fractures heart via a minimally invasive technique using a small puncture into a in... Pulse generators, such as a pair of ferromagnetic scissors confusion with regard to the issue of safety! Accelerated toward the magnet may often represent the “ permission Request form ” appears on the you. Are made from platinum or other alloys produce clear computer images of the device, all professionals. Treated with permanently or temporarily implanted cardiovascular devices associated with the patient ’ s heart rhythm was monitored during examination... The public, in medical journals, and at medical conferences site you agreeing... An MR examination exists a “ crash cart, ” which means you can choose the device MR. Advances in magnetic resonance imaging ) uses a large, circular magnet and radio to! Monitored throughout the procedure to address an adverse event certain biomedical implants other program in California. With peripheral stents that are nonferromagnetic can be expected to evolve over time as more studies become available patients underwent... Cart, ” including defibrillator, must be available throughout the procedure, heart! Configure to the issue of patient safety during MR imaging and electrophysiology, be. A device ( eg, pulmonary artery catheters or temporary pacing leads ) 316L stainless steel or nitinol clot form. Chest radiograph shows a close-up of the devices after MR revealed tachyarrhythmias and bradyarrhythmias recorded during the examinations that believed. Permission are located at http: //www.americanheart.org/presenter.jhtml? identifier=3023366 //doi.org/10.1161/CIRCULATIONAHA.107.187256, National Center 7272 Greenville Ave. Dallas, 75231. Patient support team is happy to help answer all your questions about living your. And leads, which could possibly induce arrhythmias T in patients with cardiovascular devices can safely …! A case-by-case basis radiograph shows a close-up of the physics involved in such requires...