The Benefits of RMN are Not Theoretical

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  • Unprecedented Catheter Precision & Reach

Precision

RMN’s 1mm/1° precision is unmatched by even the most skilled hands. By navigating directly from the catheter tip, you avoid the inherent errors of translating force from the handle through the catheter shaft. You wouldn’t hold a pencil from its eraser. Take control of the catheter from its tip.

Reach

RMN enables a catheter to navigate anatomy that is often unreachable. Magnetic catheters are designed with more flexible shafts and are free from the constraints of the pull wires in traditional catheters. Navigating directly from the tip, magnetic catheters can accommodate an unprecedented number of twists and turns without compromising flexibility. Break free from traditional constraints. Reach further.

  • Stable Focal Contact in a Beating Heart

Bench model video courtesy of The University of Sydney & Westmead Hospital, Sydney Australia

Effective Catheter-Tissue Contact

The only way to ensure successful lesion formation is through effective catheter-tissue contact.1 Manual catheters are unstable and experience wide fluctuations in contact force with the beating heart. An RMN catheter has a flexible shaft which serves as a shock absorber. It is driven from the tip which maintains stability. Ensure stable contact with the beating heart while maintaining consistent force throughout the cardiac cycle.

  • Physician Safety & Enhanced Skill

Occupational Cancer Risk

A study of interventional physicians with brain tumors found that 85% of tumors were in the left side of the brain, the side which typically faces the x-ray source.3

Loss of Vision

50% of interventional cardiologists and 41% of cardiac cath nurses and technicians had significant posterior subcapsular lens changes.4

Orthopedic Burden of Lead

49% of interventional cardiologists have suffered one or more orthopedic injuries as a direct result of their work in the cath lab.5

Like smoking, the cumulative impact of daily radiation exposure and hours standing in lead can be devastating. With RMN, you and your team perform the procedure seated, unscrubbed, and protected from radiation in the comfort of the control room. Avoid the risk and burden of manual navigation.

Enhance & Augment Your Skill

Take Control

Be the pilot of the procedure with all the data and control at your fingertips. Rotate the map. Annotate points. Adjust the ECG. Sit alongside your mapping and technical support instead of shouting between rooms. View the critical information you need on the large screen display, and make the best treatment decisions for your patient. This is the way interventional medicine was meant to be performed.

Focus on the Essentials

Ablation is a science and an art. Seated at the control station, you can focus your mind on the design and execution of the procedure, not on the mechanical manipulation of the catheter.

Reduce Stress

Seated, unscrubbed, and without lead. The RMN environment is conducive to a positive experience, even after a long day and during the most challenging procedures. Your patient depends on you, and that is stressful enough.

  • Patient Safety & Outcomes

Reducing Adverse Events

Manual catheters are rigid – they are designed rigid in order to translate your hand movements from the handle to the catheter tip. The RMN catheter is guided by the small magnet in its tip and does not require the same rigidity. It is flexible and gentle, which translates into reduced risk and improved safety for your patient.

Moving Toward a Fluoro-less Future

A typical manual cardiac ablation procedure can expose your patient to 15 mSv, the equivalent of 760 standard chest x-rays.2 With RMN you can be more confident in the safety of the RMN catheter and have all the procedure data presented on a large screen in front of you. This lends itself to much lower usage of x-ray. The supportive clinical data is consistent and clinically meaningful.

Advocates

  1. Ariyarathna N, Kumar S, Thomas SP, Stevenson WG, and Michaud GF. Role of Contact Force Sensing in Catheter Ablation of Cardiac Arrhythmias: Evolution or History Repeating Itself? JACC Clin Electrophysiol. 2018;4(6):707-23.
  2. Heidbuchel H, Wittkampf FHM, Vano E, Ernst S, Schilling R, Picano E, et al. Practical ways to reduce radiation dose for patients and staff during device implantations and electrophysiological procedures. EP Europace. 2014;16(7):946-64.
  3. Roguin A, Goldstein J, Bar O, Goldstein JA. Brain and neck tumors among physicians performing interventional procedures. Am J Cardiol. 2013;111(9):1368-72.
  4. Vano E, Leiman NJ, Duran A, Romano-Miller M, Rehani MM. Radiation-associated lens opacities in catheterization personnel: results of a survey and direct assessments. J Vasc Interv Radiol. 2013;24(2):197-204.
  5. Klein LW, Tra Y, Garratt KN, Powell W, Lopez-Cruz G, Chambers C, et al. Occupational health hazards of interventional cardiologists in the current decade: Results of the 2014 SCAI membership survey. Catheter Cardiovasc Interv. 2015;86(5):913-24.
  6. Szili-Torok T, Schwagten B, Akca F, Bauernfeind T, Abkenari LD, Haitsma D, et al. Catheter ablation of ventricular tachycardias using remote magnetic navigation: a consecutive case-control study. J Cardiovasc Electrophysiol. 2012;23(9):948-54.
  7. Dinov B, Schönbauer R, Wojdyla-Hordynska A, Braunschweig F, Richter S, Altmann D, et al. Long-term efficacy of single procedure remote magnetic catheter navigation for ablation of ischemic ventricular tachycardia: a retrospective study. J Cardiovasc Electrophysiol. 2012;23(5):499-505.
  8. Koutalas E, Bertagnolli L, Sommer P, Richter S, Rolf S, Breithardt O, et al. Efficacy and safety of remote magnetic catheter navigation vs. manual steerable sheath-guided ablation for catheter ablation of atrial fibrillation: a case-control study. Europace. 2015;17(2):232-8.
  1. Hendriks AA, Akca F, Dabiri Abkenari L, Khan M, Bhaqwandien R, Yap SC, et al. Safety and clinical outcome of catheter ablation of ventricular arrhythmias using contact force sensing: consecutive case series. J Cardiovasc Electrophysiol. 2015;26(11):1224-9.
  2. Akca F, Janse P, Theuns DA, and Szili-Torok T. A prospective study on safety of catheter ablation procedures: contact force guided ablation could reduce the risk of cardiac perforation. Int J Cardiol. 2015;179:441-8.
  3. Di Biase L, Tung R, Burkhardt JD, Romero J, Trivedi C, Mohanty S, et al. Scar homogeneization ablation in patients with ischemic cardiomyopathy: comparison between remote magnetic navigation and manual ablation. Circulation. 2015;132 Suppl 3.
  4. Weiss JP, May HT, Bair TL, Crandall BG, Cutler MJ, Day JD, et al. A Comparison of Remote Magnetic Irrigated Tip Ablation versus Manual Catheter Irrigated Tip Catheter Ablation With and Without Force Sensing Feedback. J Cardiovasc Electrophysiol. 2016;27 Suppl 1:S5-S10.
  5. Adragão PP, Cavaco D, Ferreira AM, Costa FM, Parreira L, Carmo P, et al. Safety and Long-Term Outcomes of Catheter Ablation of Atrial Fibrillation Using Magnetic Navigation versus Manual Conventional Ablation: A Propensity-Score Analysis. J Cardiovasc Electrophysiol. 2016;27 Suppl 1:S11-6.
  6. Lim PCY, Toh JJH, Loh J, Lee ECY, Chong DTT, Tan BY, et al. Remote magnetic catheter navigation versus conventional ablation in atrial fibrillation ablation: Fluoroscopy reduction. J Arrhythm. 2017;33(3):167-71.
  7. Yuan S, Holmqvist F, Kongstad O, Jensen SM, Wang L, Ljungström E, et al. Long-term outcomes of the current remote magnetic catheter navigation technique for ablation of atrial fibrillation. Scand Cardiovasc J. 2017;51(6):308-15.
  1. Kataria V, Berte B, Vandekerckhove Y, Tavernier R, and Duytschaever M. Remote Magnetic versus Manual Navigation for Radiofrequency Ablation of Paroxysmal Atrial Fibrillation: Long-Term, Controlled Data in a Large Cohort. Biomed Res Int. 2017;2017:6323729.
  2. Qiu X, Zhang N, Luo Q, Liu A, Ji Y, Ye J, et al. Remote magnetic navigation facilitates the ablations of frequent ventricular premature complexes originating from the outflow tract and the valve annulus as compared to manual control navigation. Int J Cardiol. 2018;267:94-99.
  3. Reents T, Jilek C, Schuster P, Nölker G, Koch-Büttner K, Ammar-Busch S, et al. Multicenter, randomized comparison between magnetically navigated and manually guided radiofrequency ablation of atrioventricular nodal reentrant tachycardia (the MagMa-AVNRT-trial). Clin Res Cardiol. 2017;106(12):947-52.
  4. Kawamura M, Scheinman MM, Tseng ZH, Lee BK, Marcus GM, Badhwar N. Comparison of remote magnetic navigation ablation and manual ablation of idiopathic ventricular arrhythmia after failed manual ablation. J Interv Card Electrophysiol. 2017;48(1):35-42.
  5. Akca F, Theuns DAMJ, Dabiri Abkenari L, de Groot NMS, Jordaens L, Szili-Torok T. Outcomes of repeat catheter ablation using magnetic navigation or conventional ablation. EP Europace. 2013;15(10):1426-31.
  6. Roudijk RW, Gujic M, Suman-Horduna I. Catheter ablation in children and young adults: is there an additional benefit from remote magnetic navigation? Net Heart J. 2013;21:296–303.
  7. Kim JJ, Macicek SL, Decker JA, Kertesz NJ, Friedman RA, Cannon BC. Magnetic versus manual catheter navigation for ablation of free wall accessory pathways in children. Circ Arrhythm Electrophysiol. 2012; 2012;5:804-8.

Stereotaxis Intended Use Statements, United States Labeling:

The Niobe™ ES system is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature, and peripheral vasculature by orienting the device tip in a desired direction. The Stereotaxis Cardiodrive™ automated catheter advancement system (CAS) is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient’s heart when used in conjunction with a Stereotaxis magnetic navigation system. The Cardiodrive™ system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.

Consult the associated product labeling for the Indications for Use and instructions of other devices used in conjunction with Stereotaxis products.

Niobe™ and Cardiodrive™ are trademarks of Stereotaxis, Inc. registered in the United States, European Community, and Japan.