Revo MRI Pacing System

Transcription

1 Brief Statement The Revo MRI SureScan pacing system is MR Conditional and as such is designed to allow patients to undergo MRI under the specified conditions for use. Indications: The Revo MRI SureScan Model RVDR01 IPG is indicated for use as a system consisting of a Medtronic Revo MRI SureScan IPG implanted with two CapSureFix MRI SureScan 5086MRI leads. A complete system is required for use in the MRI environment. The Revo MRI SureScan Model RVDR01 IPG is indicated for the following: Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity Accepted patient conditions warranting chronic cardiac pacing include: Symptomatic paroxysmal or permanent second- or thirddegree AV block Symptomatic bilateral bundle branch block Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias The device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include: Various degrees of AV block to maintain the atrial contribution to cardiac output VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications. Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in bradycardia patients with atrial septal lead placement and one or more of the above pacing indications. Contraindications: The device is contraindicated for: Implantation with unipolar pacing leads Concomitant implantation with another bradycardia device Concomitant implantation with an implantable cardioverter defibrillator Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN USA Tel: (763) Fax: (763) Medtronic USA, Inc. Toll-free: 1 (800) (24-hour technical support for physicians and medical professionals) There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient s age and medical condition, however, may dictate the particular pacing system, mode of operation, and implantation procedure used by the physician. Rate responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance ATP therapy is contraindicated in patients with an accessory antegrade pathway Warnings and Precautions: Changes in patient s disease and/or medications may alter the efficacy of the device s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Use of the device should not change the application of established anticoagulation protocols. Patients and their implanted systems must be screened to meet the MRI Conditions of Use. Do not scan patients who do not have a complete Revo MRI SureScan pacing system consisting of a SureScan device and two SureScan leads; patients who have previously implanted devices, or broken or intermittent leads; or patients who have a lead impedance value of < 200 Ω or > 1,500 Ω. Do not scan patients with a SureScan pacing system implanted in sites other than the left and right pectoral region; or patients positioned such that the isocenter (center of MRI bore) is inferior to C1 vertebra and superior to the T12 vertebra. Potential Complications: Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. Potential lead complications include, but are not limited to, valve damage, fibrillation, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation, or exit block. The SureScan system has been designed to minimize potential complications in the MRI environment. Potential MRI complications include, but are not limited to, lead electrode and/or device heating which may cause tissue damage, impact the pacing system functionality such as failure to detect/treat irregular heartbeats, or potential for VT/VF induction. See the device manuals before performing an MRI Scan for detailed information regarding the implant procedure, indications, MRI conditions of use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic at 1 (800) and/or consult Medtronic s website at Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. UC b EN Medtronic, Inc Minneapolis, MN. All Rights Reserved. Printed in USA. 07/2012 Revo MRI Pacing System ENGINEERED WITH SURESCAN TECHNOLOGY FDA-approved for MRI use The first pacing system to break the image barrier The Revo MRI SureScan pacing system is MR Conditional designed to allow patients to undergo MRI under the specified conditions for use. A complete system, consisting of a Medtronic Revo MRI SureScan IPG implanted with two CapSureFix MRI SureScan leads is required for use in the MRI environment.

2 The First and Only Pacing System FDA-Approved for MRI Use MRI Development Program Initiated research Began technology work with international experts Commenced formal discussions with regulatory bodies (TUV, FDA ) Completed first system modifications; started extensive test program Finalized device modifications; defined human clinical trial Clinical trial completed 2011 Commenced worldwide 1st-generation Revo MRI SureScan pacing system clinical trial Revo MRI pacing system receives FDA approval Specifically engineered for MRI safety, with reliable lead technology and a proven pacemaker platform this is state-of-the-art pacing. Now your patients get proven cardiac care with MRI access.

3 Meeting the Need for MRI Pacemaker Implants in an Aging Population The number of pacemakers currently implanted in the United States is approximately 1.5 million 1,2 Average Age of Pacemaker Patient 13% Age % Age 65+ The Pacemaker Population Elderly patients are the primary users of MRI: individuals over age 65 are twice as likely to need an MRI compared to younger recipients. 3

4 Part of Comprehensive Patient Care Now, for the first time, you can implant a state-of-the-art pacing system to provide proven cardiac care AND MRI access when your patients need it Number of Comorbidities in Pacemaker Patients Medical and Surgical Specialties Rely on MRI for Diagnosis. Your choice can affect their decisions and diagnostic capabilities Cardiologist DEVICE CHOICE Electrophysiologist 15% 0 comorbidities 27% 3 or more comorbidities 30% 1 comorbidity 28% 2 comorbidities 85% 1 1 or more comorbidities Ophthalmology Otolaryngology Cardiothoracic Surgery Surgical Oncology Nephrology Gynecologic Oncology Urology Neurosurgery Neurology Oncology Radiation Oncology Interventional Radiology Gastrointestinal Surgery Orthopedic Surgery Comprehensive Care Given that 85% of all pacemaker patients have one or more comorbidities, facilitating comprehensive multi-specialty care is important in today s environment Rheumatology Vascular Surgery

5 Prevalence of Common Comorbidities in the Pacemaker Patient Population MRI Is the Gold Standard Diagnostic Tool for Neurologists, Oncologists, and Orthopedic Surgeons, Whose Patients Are Often over 65 Years of Age. 7 MRI is unmatched in its ability to accurately visualize soft tissue The Prevalence of Common Comorbidities Increases Rapidly Over Age It is estimated that 50 to 75% of pacemaker patients will have a medical need for an MRI over the lifetime of their device 1 18% Prevalence in US Population 16% 14% 12% 10% 8% 6% 4% Stroke Prostate Cancer Osteoarthritis Colorectal Cancer The Most Common Reasons for MRI Referral Are Musculoskeletal and Neurological Symptoms. 8 Medicare records show that in patients > 65 years of age with an implanted pacemaker: 34% have spine and intervertebral disc disease 9 36% have chronic pain of wrist, foot, ankle, or elbow 9 2% 14% suffer from injury or trauma to the spine, knee, or shoulder 9 0% 30s 40s 50s 60s 70s Age by Decade Prevalence of Coexisting Conditions

6 Hazards and Risks of MRI with Current Pacing Systems Since 2008, the safety and risk concerns of MRIs in cardiac device patients have been documented in 17 studies MRI can put pacemaker patients at risk for any of the following 25 : Potential Hazard Lead Heating The conductive pacing lead acts as an antenna, picking up radiofrequency energy. A portion of this energy is dissipated as heat in the cardiac tissue nears the tip electrode. Unintended Cardiac Stimulation The gradient and radiofrequency fields will induce voltages in pacemaker leads that will be applied to the pacing lead electrodes. If these voltage pulses are large enough, they may directly stimulate the heart. Device Interactions The gradient, radiofrequency, and static fields may adversely affect the electrical operation of the pacemaker system if its operation is not protected from the effects of those fields. Device Field Impact Static Gradient RF Tissue damage may affect pacing therapy. May lead to a single or intermittent stimulation, or sustained tachycardia. Pacemaker malfunction or failure may affect pacing therapy. Hazards and Risks of MRI MR Conditional Risk Information A complete Revo MRI SureScan pacing system including a Revo MRI SureScan IPG and two CapSureFix MRI SureScan leads is required for use in the MRI environment Any other pacing system combination may result in a hazard to the patient during an MRI scan When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing Refer to the Revo MRI Pacing System Conditions for Use located in the device manuals prior to scanning a patient. Consult Medtronic s website at or call Medtronic at 1 (800)

7 Specifically Engineered for MRI Safety Device Design Solutions Input circuits optimized Circuit design immune to interference SureScan pacing mode Asynchronous pacing High pacing outputs The Revo MRI SureScan pacing system has completed clinical evaluation, regulatory review, and FDA approval and is safe for use when used according to the MRI conditions for use as defined in the SureScan manual The implanted system must consist solely of a Medtronic Revo MRI SureScan Model RVDR01 device and two CapSureFix MRI SureScan Model 5086MRI leads Revo MRI SureScan Pacemaker A Pacemaker Engineered with Multiple Safety Features Device verification appears on pacemaker programmer screen Automatic testing ensures only appropriate battery and impedance data are collected during MRI Dedicated programming mode provides additional security/backup for Power On Reset (POR) Hall sensor immune to strong magnetic fields Key Product Features Easily Identifiable, Radiopaque Icon Confirms SureScan Device Implant Revo MRI Pacing System Size 12.7 cc Weight 21.5 g

8 Lead Heating Design Solution Lead inner conductor coil design mitigates lead heating 4 filar to 2 filar increases inductance and reduces heating Materials identical to 5076* Model 5086MRI lead flex testing Connector/body Lead body Model 5086MRI clinical implant experience starting February 2007 (928 leads implanted) Easily Identifiable, Radiopaque Icon Confirms SureScan Device Implant CapSureFix MRI Model 5086 Polarity Shape Fixation Inner/Outer Insulator Body Recommended Introducer Size Tip-to-Ring Spacing Standard Lengths Bipolar Straight Screw-in Silicone 7 Fr 8 Fr (without guide wire) 10 mm 45 cm, 52 cm, 58 cm * Exception of MRI Marker band and electrode coating Lead Heating Model 5076 versus Model 5086MRI CapSureFix MRI SureScan Lead Model 5086 A Lead Designed for MRI Use The state-of-the-art 5086 leads are specifically designed and engineered for safety within an MRI environment The 5086 lead is based on the CapSureFix family of leads, which have been implanted in more than 1 million patients worldwide that s 2.5 million leads, with 99.5% reliability Percent of Maximum Temperature Model Model Lead Path the x-axis represents 50 anatomically relevant leads paths the results demonstrate significant variability in lead tip heating as a function of the lead path overall the 5086MRI lead heats approximately 3 times less than the 5076 for most lead paths

9 Preclinical Research Demonstrates the Safety of Revo MRI Pacing System 7 Testing Summary Extensive preclinical evaluation was based on clinically relevant as well as worst-case scan conditions, using in vitro (bench) testing, in vivo (animal) testing, and computer simulations (modeling). MRI-Induced Lead Heating Simulations in Human Body Models Using Different Lead Combinations MRI-Induced Unintended Cardiac Stimulation (UCS) Analysis combined a prediction for the induced voltage pulse widths and amplitudes and an in vivo canine study to evaluate the stimulation threshold to these pulses The risk of reaching the gradient stimulation range is 1/1,000,000 which remains outside the capture range Results confirmed that patient risk from UCS is at an acceptable level Gradient Stimulation Strength Duration Curve Human Body Library Lead Paths 1/1,000 Pulse Amplitude Voltage (V) Capture Preclinical Research Human body models encompassed 2nd to 97th percentile of all human bodies, with ten different lead paths Over 400,000 different lead/body combinations were analyzed to derive a minimal probability of a 0.5 V threshold Gradient Stimulation Range /1,000 Pulse Width Effective Pulse Width (ms)

10 Clinical Trial Demonstrates the Safety of Revo MRI SureScan 26 Study Design Multicenter, randomized, controlled clinical trial designed to evaluate the safety of the Revo MRI SureScan pacing system, including any MRI-related complications, as well as to analyze pacing capture thresholds and sensing amplitude 464 patients received a Revo MRI SureScan pacing system and were then randomized to elective MRI or no MRI, approximately 9-12 weeks post-implant MRI imaging intended to represent commonly used, clinically relevant scans Methods Visit Schedule Percent of Subjects Key Results 100% were free of MRI-related complications (n = 211, p < 0.001) No sustained atrial or ventricular arrhythmias, no asystole, no pacemaker output inhibition, and no electrical resets in the group receiving MRI Minimal changes in pacing capture thresholds, as shown on the following chart Primary Effectiveness End Point: Atrial and Ventricular Capture Threshold Threshold changes pre-mri/control visit to 1-month post-mri/control visit Percent of Subjects MRI Group Control Group Enrollment Implant and Randomization 9-12-Week Visit Pre-MRI Change in Atrial Threshold (V) Change in Ventricular Threshold (V) 2-Month Visit MRI Group MRI Scans Post-MRI Control Group No MRI 1-Week Post-MRI Visit 1-Month Post-MRI Visit 6-Month Post-Implant Visit and Every 6 Months Thereafter No discernible difference between the MRI and control groups Clinical Support

11 Builds upon Medtronic Innovations Medtronic founded First external pacemaker Activitrax pacemaker rate response Thera pacemaker first microprocessor-based, mode switching Kappa pacemaker rate-response via activity and minute ventilation Medtronic CareLink Network MVP promotes intrinsic conduction 2011 Revo MRI Pacing System A History of Innovation MVP Managed Ventricular Pacing Exclusive technology that used Atrial Pacing (AAIR) primarily with DDD pacing only when necessary MVP reduces unnecessary RV pacing by 99% 27 ACC/AHA/HRS guidelines 28 state the need to reduce unnecessary pacing as much as possible. The following studies support the guidelines: MOST 29 : Every incremental 1% of unnecessary VP increases the risk for heart failure hospitalizations by 5.4% and for AF by 1%. CareLink Network* The leading Internet-based remote monitoring service for implanted devices 32 Serving nearly 500,000 patients in 3,000 clinics in the United States * Not all devices are available on the CareLink Network. Danish II 30 : Even with long AV delays, the risk of AF doubles with DDD(R) pacing compared to AAI(R) with DDD(R) backup. Gardiwal 31 : Patients with 72% RV pacing are at increased risk for VT/VF.

12 References 1 Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE. April 2005;28(4): Zhan C, Baine WB, Sedrakyan A, Steiner C. Cardiac device implantation in the United States from 1997 through 2004: a population-based analysis. Gen Intern Med. January 2008;23(suppl 1): Global Industry Analysts, Inc. Magnetic Resonance Imaging (MRI) Equipment A Global Strategic Business Report. San Jose, CA National Cancer Institute April US estimated complete prevalence (including counts) by age on 1/1/2006. Based on November 2008 SEER data submission; DCCPS, Surveillance Research Program, Statistical Research and Applications Branch. 5 Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. May 1998;41(5): American Heart Association. Heart Disease and Stroke Statistics 2010 Update: Learn and Live. Prevalence of stroke by age and sex (NHANES: ). 7 Medtronic Revo MRI FDA Panel Pack: CommitteesMeetingMaterials/MedicalDevices/ MedicalDevicesAdvisoryCommittee/ CirculatorySystemDevicesPanel/ucm htm. 8 Medical Imaging Survey, Medicare Fee-for-Service Review, Naehle CP, Zeijlemaker V, Thomas D, et al. Evaluation of cumulative effects of MR imaging on pacemaker systems at 1.5 Tesla. Pacing Clin Electrophysiol. December 2009;32(12): Goldsher D, Jahshan S, Roguin A. Successful cervical MR scan in a patient several hours after pacemaker implantation. Pacing Clin Electrophysiol. October 2009;32(10): Gimbel JR. Unexpected asystole during 3T magnetic resonance imaging of a pacemaker-dependent patient with a modern pacemaker. Europace. September 2009;11(9): Naehle CP, Strach K, Thomas D, et al. Magnetic resonance imaging at 1.5-T in patients with implantable cardioverter-defibrillators. J Am Coll Cardiol. August 4, 2009;54(6): Roguin A. Magnetic resonance imaging in patients with implantable cardioverter-defibrillators and pacemakers. J Am Coll Cardiol. August 4, 2009;54(6): Mollerus M, Albin G, Lipinski M, Lucca J. Cardiac biomarkers in patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing an MRI scan. Pacing Clin Electrophysiol. October 2008;31(10): Pulver AF, Puchalski MD, Bradley DJ, et al. Safety and imaging quality of MRI in pediatric and adult congenital heart disease patients with pacemakers. Pacing Clin Electrophysiol. April 2009;32(4): Nordbeck P, Weiss I, Ehses P, et al. Measuring RF-induced currents inside implants: impact of device configuration on MRI safety of cardiac pacemaker leads. Magn Reson Med. March 2009;61(3): Sutton R, Kanal E, Wilkoff BL, et al. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials. December 2, 2008;9(1): Naehle CP, Meyer C, Thomas D, et al. Safety of brain 3-T MR imaging with transmit-receive head coil in patients with cardiac pacemakers: pilot prospective study with 51 examinations. Radiology. December 2008;249(3): Calcagnini G, Triventi M, Censi F, et al. In vitro investigation of pacemaker lead heating induced by magnetic resonance imaging: role of implant geometry. J Magn Reson Imaging. October 2008;28(4): Dyrda K, Khairy P. Implantable rhythm devices and electromagnetic interference: myth or reality? Expert Rev Cardiovasc Ther. July 2008;6(6): Gimbel JR. Magnetic resonance imaging of implantable cardiac rhythm devices at 3.0 tesla. Pacing Clin Electrophysiol. July 2008;31(7): Nordbeck P, Bauer WR. [Safety of cardiac pacemakers and implantable cardioverter-defibrillators in magnetic resonance imaging. Assessment of the aggregate function at 1.5 tesla.] Dtsch Med Wochenschr. March 2008;133(13): [Article in German.] 24 Tandri H, Zviman MM, Wedan SR, Lloyd T, Berger RD, Halperin H. Determinants of gradient field-induced current in a pacemaker lead system in a magnetic resonance imaging environment. Heart Rhythm. March 2008;5(3): Roguin A, Zviman MM, Meininger GR, et al. Modern pacemaker and implantable cardioverter/defibrillator systems can be magnet resonance imaging safe: in vitro and in vivo assessment of safety and function at 1.5 T. Circulation. August 3, 2004;110(5): Medtronic, Inc. Revo MRI SureScan pacing system clinical summary Gillis AM, Pürerfellner H, Israel CW, et al. Reduction of unnecessary right ventricular pacing due to the Managed Ventricular Pacing (MVP) mode in patients with symptomatic bradycardia: benefit for both sinus node disease and AV block indications. Heart Rhythm. 2005;Abstract AB Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/ AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. May 27, 2008;51(21):e Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. June 17, 2003;107(23): Nielsen JC, Kristensen L, Andersen HR, Mortensen PT, Pedersen OL, Pedersen AK. A randomized comparison of atrial and dual-chamber pacing in 177 consecutive patients with sick sinus syndrome: echocardiographic and clinical outcome. J Am Coll Cardiol. August 20, 2003;42(4): Gardiwal A, Yu H, Oswald H, et al. Right ventricular pacing is an independent predictor for ventricular tachycardia/ventricular fibrillation occurrence and heart failure events in patients with an implantable cardioverter-defibrillator. Europace. March 2008;10(3): Medtronic CareLink Metrics Database. Revo MRI Pacing System Conditions for Use A complete Revo MRI SureScan pacing system, including a Revo MRI SureScan IPG and two SureScan leads is required for use in the MRI environment. Any other combination may result in a hazard to the patient during an MRI scan. The SureScan feature must be programmed to On prior to scanning a patient according to the specified conditions for use. Cardiology requirements: Patients and their implanted systems must be screened to meet the following requirements: no previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history a Revo MRI SureScan pacing system that has been implanted for a minimum of 6 weeks a Revo MRI SureScan pacing system implanted in the left or right pectoral region pacing capture thresholds of 2.0 volts (V) at a pulse width of 0.4 milliseconds (ms) a lead impedance value of 200 ohms (Ω) and 1,500 Ω no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is on Radiology requirements: Horizontal cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) must be used Gradient systems with maximum gradient slew rate performance per axis of 200 Teslas per meter per second (T/m/s) must be used The scanner must be operated in Normal Operating Mode: The whole body averaged specific absorption rate (SAR) must be 2.0 watts per kilogram (W/kg) The head SAR must be < 3.2 W/kg The patient must be positioned within the bore such that the isocenter (center of the MRI bore) is superior to the C1 vertebra or inferior to the T12 vertebra Proper patient monitoring must be provided during the MRI scan. The methods include visual and verbal contact with the patient, electrocardiography, and pulse oximetry (plethysmography) Training requirements: A health professional who has completed cardiology SureScan training must be present during the programming of the SureScan feature A health professional who has completed radiology SureScan training must be present during the MRI scan Brief Statement Medtronic CareLink Monitor/CareLink Network Intended Use The CareLink Monitor and the CareLink Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. Contraindications There are no contraindications for the CareLink Monitor. Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. Warnings and Precautions The CareLink Monitor must only be used for interrogating compatible Medtronic implantable devices. The CareLink Monitor is intended for use within the prescribing country. See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) and/or consult Medtronic s website at Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.