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1 Managing Heart Failure Utilizing Ambulatory PA Pressure Monitoring Benjamin Johnson, MD CentraCare Heart & Vascular Center SJM-MEM c Item approved for U.S. use only. 1 1 Conflicts of Interest Abbott Vascular: Travel expenses 2 Time Line of Heart Failure Decompensation SJM-MEM c Item approved for U.S. use only. 3 3 * Graph adapted from Adamson PB, et al. Curr Heart Fail Reports,

2 Objectives Background/Epidemiology Device Overview Study Data Case study/patient Workflow CentraCare Data SJM-MEM c Item approved for U.S. use only. 4 4 Despite Medical Advances, Heart Failure Hospitalization is a Worsening Epidemic SIGNIFICANT REDUCTION IN CORONARY DEATHS 1 SIGNIFICANT INCREASE IN HF HOSPITALIZATIONS 2 Deaths/100,000 Population Number of HF Hospitalizations with HF as Primary or Secondary Diagnosis, by 5 year Time Period 20,000,000 15,000,000 10,000,000 5,000, THE PROBLEM: Unless focused, dramatic measures are taken, the clinical and financial burden to society is only going to escalate. SJM-MEM c 1. NIH.gov, Accessed Item approved for U.S. use only Fang J, et al. J Am Coll Cardiol, Heart Failure is a Growing Economic Burden UNITED STATES HOSPITALIZATIONS AND READMISSIONS > 3,000,000 hospitalizations hospitalizations for HF 1 include HF as a contributor. 2 > 1,100,000 ~5 days average length of hospital stay 3 ~25% all-cause readmission within 30 days; ~50% within 6 months. 4,5 Total medical costs for HF are projected to increase to $70B by 2030, a 2x increase from 2013.* COSTS 50% of the costs are attributed to hospitalization. 6 Despite advances in medical therapies to treat heart failure, the hospitalization rate has not changed significantly from As a result, heart failure continues to be a MAJOR DRIVER OF OVERALL HEALTH CARE COSTS. *Study projections assumes HF prevalence remains constant and continuation of current hospitalization practices 6 1. CDC NCHS National Hospital Discharge Survey, Blekcer et al. J Am Coll Cardiol, Yancy et al. J Am Coll Cardiol, SJM-MEM c Item approved for U.S. use only Wxler DJ, et al. Am Heart J, Krumholz HM, et al. Circ Cardiovas Qual Outcomes, Yancy CW, et al. Circulation,

3 Heart Failure is a Growing Global Clinical Burden UNITED STATES PREVALENCE 2.2% Prevalence 1 5.7m HF patients 1 INCIDENCE MORBIDITY AND MORTALITY For AHA/ACC stage C/D patients diagnosed with HF: 915,000 people 45 years of age are newly diagnosed each year with HF. 1 Projected to increase to > 8M people 18 years of age with HF by % 50% 6 months. 2 Readmitted within Will die within 5 years. 3 HIGH PREVALENCE, HIGH INCIDENCE, AND POOR PROGNOSIS despite advances in the treatment of heart failure over the past few decades. 1. AHA 2016 Statistics at a Glance, SJM-MEM c Item approved for U.S. use only Krumholz HM, et al. Circ Cardiovas Qual Outcomes, Heidenreich PA, et al. Circ Heart Failure, THE CHALLENGE Current Tools are Ineffective in Reducing the Clinical and Economic Burden of HF SJM-MEM c Item approved for U.S. use only SJM MEM (1)a(10) Item approved for global use. 8 Goal of Heart Failure Management: SLOW DISEASE PROGRESSION BY PREVENTING DECOMPENSATION EACH EVENT ACCELERATES DOWNWARD SPIRAL OF MYOCARDIAL FUNCTION With each subsequent HF-related admission, the patient leaves the hospital with a further decrease in cardiac function. MYOCARDIAL FUNCTION Acute Event THE GOAL: Maintain euvolemia to avoid acute decompensation and hospitalization HF HOSPITALIZATION is a valid endpoint for measuring decompensation TIME Gheorghiade MD, et al. Am J. Cardiol, SJM-MEM c Item approved for U.S. use only

4 Long-term Mortality Risk Increases with Multiple Hospitalizations 4th admission (n = 417) 3rd admission (n = 1,123) 2nd admission (n = 3,358) 1st admission (n = 14,374) Kaplan-Meier cumulative mortality curve all-cause mortality after each subsequent hospitalization for HF. Setoguchi S, Stevenson LW, Schneeweiss S, Am Heart J, 2007;154: SJM-MEM c Item approved for U.S. use only Current HF Management Tools are Not Effective at Reducing HF Hospitalizations 90% of HF hospitalizations due to symptoms of pulmonary congestion 1,2 40% moderate to severe congestion 3 AT DISCHARGE Post hoc analysis of 463 acute decompensated HF patients from DOSE HF and CARRESS HF 60% absent or mild congestion 3 AT 60 DAY FOLLOW UP Today s tools are INADEQUATE 41% of previously decongested patients had severe or partial re congestion 3 1. Adams KF, et al. Am Heart J, Krum SJM-MEM c H and Abraham WT. Lancet, Item approved for U.S. use only Lala A, et al. J Cardiac Fail, Current HF Management Tools Designed to Predict Decompensation FACE TO FACE EVALUATION PARAMETER SURROGATE FOR: Symptoms (PND, orthopnea, etc.) LVEDP, RAP JVP RAP HJR S3 Rales Daily weight BNP and NT probnp Intrathoracic impedance Heart rate variability RAP LVEDP LVEDP Body volume (LVEDP, RAP) PCWP PCWP Cardiac autonomic control THE GOAL: Predict gradual decompensation leading to acute decompensation SJM-MEM c Item approved for U.S. use only

5 Weight Change is Not a Reliable Indicator of Rising Pressure or Impending Decompensation WEIGHT GAIN SENSITIVITY SPECIFICITY 2 kg (4.5 lbs) weight gain over hrs 2 9% 97% 2% weight gain over hrs 2 17% 94% 3 lbs in 1 day or 22.5% - 5 lbs in 3 days 3 NO CORRELATION Daily weights do not correlate with filling pressures 1. Data based on Zile MR, et al. Circulation, Presented at FDA Advisory Panel, October 9, SJM-MEM c Item approved for U.S. use only Lewin J, et al. Eur J HF, Abraham WT, et al. Cong Heart Failure, Clinical Examinations are not Reliable for Assessing Rising Pressure POOR SENSITIVITY & SPECIFICITY VARIABLE ESTIMATE OF SENSITIVITY (%) SPECIFICITY (%) PPV (%) NPV (%) JVP EDEMA PULSE PRESS S3 DYSPNEA RALES N = 366 RAP Cardiac Index PCWP Clinical examination has LIMITED RELIABILITY in assessing filling pressures. Table adapted from Capomolla S, et al. Eur J Heart Failure, SJM-MEM c Item approved for U.S. use only Non-hemodynamic-based Remote Monitoring: DOES NOT REDUCE HF HOSPITALIZATION TRIAL N PARAMETER MONITORED IMPACT ON HF HOSPITALIZATION JOURNAL TELE HF 1 1,653 Signs/symptoms, daily weights None The New England Journal of Medicine, 2010 TIM HF Signs/symptoms, daily weights None Circulation, 2011 TEN HMS Signs/symptoms, daily weights, BP, nurse telephone support None Journal of the American College of Cardiology, 2005 BEAT HF 4 1,437 Signs/symptoms, daily weights, nurse communications None American Heart Association, 2016 INH Signs/symptoms, telemonitoring, nurse coordinated DM None Circulation Heart Failure, 2012 DOT HF Intrathoracic impedance with patient alert Increased Circulation, 2011 Optilink 7 1,002 Intrathoracic impedance None European Journal of Heart Failure, 2011 REM HF 8 1,650 Remote monitoring via ICD, CRT-D or CRT- P None European Society of Cardiology, 2017 MORE CARE 865 Remote monitoring of advanced diagnostics 9 via CRT-D None European Journal of Heart Failure, 2016 Total 8,793 MULTIPLE TRIALS, > 8,500 PATIENTS: No reduction in HF hospitalization 1. Chaudhry SI, et al. N Engl J Med, van Veldhuisen DJ, et al. Circulation, Koehler F, et al. Circulation, Brachmann J, et al. Eur J Heart Fail, SJM-MEM c Item approved for U.S. use only Cleland JG, et al. J Am Coll Cardiol, Cowie MR, ESC, Ong MK, et al. JAMA Intern Med, Boriani G, et al. Eur J Heart Fail, Angermann DE, et al. Circ Heart Fail,

6 Pathogenesis of Worsening Heart Failure ROLE OF HEMODYNAMIC MONITORING Fluid Retention Vascular Resistance Fluid Redistribution Increased Pulmonary Artery Pressures WORSENING DYSPNEA LEADING TO HOSPITALIZATION SJM-MEM c Item approved for U.S. use only Heart Failure Management: RIGHT HEART CATHETERIZATION WITH SWAN GANZ CATHETER SJM-MEM c Item approved for U.S. use only CardioMEMS PA Pressure Monitoring System PULMONARY ARTERY PRESSURE SENSOR TARGET LOCATION FOR PA PRESSURE SENSOR PATIENT ELECTRONICS SYSTEM MERLIN. NET PCN SJM-MEM c Item approved for U.S. use only

7 Microelectrical Mechanical System (MEMS) No lead or battery, no need for replacement 19 CardioMEMS - Transmitted Data SJM-MEM c Item approved for U.S. use only CardioMEMS Trial Review SJM-MEM c Item approved for U.S. use only

8 Summary of CHAMPION Randomized Clinical Trial: 550 PREVIOUSLY HOSPITALIZED NYHA CLASS III PATIENTS Pulmonary Artery Pressure Medication Changes Based on Pulmonary Artery Pressure (p < ) Pulmonary Artery Pressure Reduction (p = 0.008) MANAGING PRESSURES TO TARGET GOAL RANGES: PA pressure systolic mmhg PA pressure diastolic 8 20 mmhg PA pressure mean mmhg Reduction in Heart Failure Hospitalizations (p < ) Quality of Life Improvement (p = 0.024) Using diuretics and vasodilators, in addition to guideline directed medical therapies 1. Abraham WT, et al. Lancet, Abraham WT, et al. Lancet, Adamson PB, et al. J Card Fail, Primary Efficacy Endpoint Met with Significantly Reduced Heart Failure Hospitalization Abraham WT, et al. Lancet, SJM-MEM c Item approved for U.S. use only Both Primary Safety Endpoints Met Freedom from Device/System Related Complications (%) 1167 patient-years of follow-up 8 device/system-related complications (DSRC) DSRC per patient-year All DSRC occurred within 30 days of implant No sensor failures Days from Implant Procedure No. at Risk

9 Monitoring with CardioMEMS HF System Leads to Reduction in Mean PA Pressure from Baseline PART 1: RANDOMIZED ACCESS PA Mean Pressure AUC (mmhg days) SECONDARY ENDPOINT: Targeting PA pressures and titrating medications results in reduction of mean PA pressure over time. Abraham WT, et al. Lancet, SJM MEM (1)a(10) Item approved for global use Champion Subgroup Analysis: PA GUIDED MEDICAL MANAGEMENT Frequency of Medication Changes by Drug Class Medication Changes All Medication Diuretic (Loop or Changes Thiazide) PA Pressure Guided HF Management (Treatment Group) Standard of Care HF Management Only (Control Group) Vasodilator ACEI/ARB Beta Blocker Aldosterone (Nitrate and Antagonist Hydralazine) Medication changes based on PA pressure information were MORE EFFECTIVE than using signs and symptoms alone. Costanzo, et al. J Am Coll Cardiol Heart Failure, Champion Subgroup Analysis: NNT Compared to Other HF Therapies SJM-MEM c Item approved for U.S. use only

10 Post-approval Observational Study of the CardioMEMS HF System Large (N = 2000) observational study from first 2000 commercially implanted patients Days between Transmissions Short term Cohort (n = 300) CHAMPION Control CHAMPION Treatment General-Use p = p < PATIENTS CONSISTENTLY UPLOAD PRESSURES Median 1.2 days between transmissions PROVIDERS CONSISTENTLY TREAT PRESSURES Larger treatment effect in the real world than CHAMPION Heywood JT, Jermyn R, Shavelle D, et al. Circulation, 2017;135: Real-world Use of the CardioMEMS HF System: ASSOCIATED HF HOSPITALIZATION COSTS $80K $70K $60K $50K $40K $30K $20K $10K $0K -$10,510 $28,870 $18,360 6 MONTH COHORT Pre Implant -$13,190 $47,690 $34, MONTH COHORT Post Implant Large (N = 1114) retrospective cohort study using the CardioMEMS HF System patients from CMS database Desai, AS, et al. J Am Coll Cardiol, 2017;69(19): What about mortality? 30 10

11 Champion Subgroup Analysis: HFrEF PATIENTS SHOWS SIGNIFICANT REDUCTION IN HF Hospitalization AND STRONG TREND TOWARDS IMPROVED SURVIVAL * Clinical Outcomes Survival Probability Rates Events/Patient yr p = % reduction 0.49 p = % 0.24 reduction 0.18 Survival Probability (%) Control Treatment 0 HF Hospitalization Rate Control Mortality Rate Treatment No. at Risk CONTROL TREATMENT Kaplan Meier Survival Analysis *The CardioMEMS HF System is not labeled for a reduction in mortality Givertz M, et al. J Am Coll Cardiol, Champion Subgroup Analysis: HFrEF PATIENTS WITH CRT D FOLLOWING GDMT 64% reduction (p = 0.028) Abraham, et al. HRS Probability of Survival 33 11

12 Hemodynamic GUIDEd Management of Heart Failure (GUIDE HF) Study Design - 2 Groups: Randomized (patient blinded) and single arm. - N = North American sites Randomized Arm Patients - Treatment Group: Manage based on PA pressure - Control Group: Manage based on standard of care (sx, weight, labs, etc). 1 Outcome - Composite of: - HF Hospitalizations - Intravenous diuretic visits - All cause mortality Inclusion Criteria - NYHA II-IV Heart failure (Systolic or Diastolic) - Elevated BNP or NTproBNP and/or prior HF hospitalization Single Arm Patients - NYHA III only with elevated BNP and/or HFH. - Manage based on PA pressures 2 Outcome - Composite of: - HF Hospitalizations - Intravenous diuretic visits - EuroQol Questionaire - KCCQ-12-6 minute walk - Mortality 34 CentraCare CardioMEMS Experience: Over 100 implants: 72 patients with at least 6 month follow up data HF hospital admissions reduced by 87% SJM-MEM c Item approved for U.S. use only Case Review: H.S. 75 Year Old Male SJM-MEM c Item approved for U.S. use only

13 Case Review: H.S. 75 Year Old Male Complex medical history notable for: Chronic HFpEF (NYHA class III) Paroxysmal AF CKD stage III HTN Morbid obesity Diabetes Mellitus COPD (on home O 2 ) Obesity hypoventilation syndrome with obstructive sleep apnea SJM-MEM c Item approved for U.S. use only Case Review: H.S. 75 Year Old Male Chronically short of breath with frequent visits to the ER & hospitalizations. Several reports of difficulty determining etiology of dyspnea. Decompensated HFpEF hospitalizations: 7/28-8/1/17: Admission wt 270 lbs Discharge wt 263 lbs. Also Rx for PNA. 8/27-8/30/17: Admission wt 271 lbs Discharge wt 270 lbs. 9/4-9/10/17: Admission wt 273 lbs Discharge wt 262 lbs. Also Rx for LE Cellulitis. Hospitalized 9/10-9/13/17 for AKI from over-diuresis. Diuretics discontinued. Admission wt 256 lbs Discharge wt 250 lbs Saw his primary cardiologist Nov Difficulty maintaining adequate volume status with recurrent HF hospitalizations. Wt 251 lbs. Patient was referred for CardioMEMs implantation SJM-MEM c Item approved for U.S. use only Case Review: H.S. 75 Year Old Male CardioMEMs implanted on 1/9/18 Weight at the time of implant: 241 lbs Right Heart Cath Implant Data: RA 12 mmhg RV 40/7 mmhg PA 40/21 (27) mmhg PCWP 22 mmhg Fick Cardiac Index 1.8 L/min/m2 SJM-MEM c Item approved for U.S. use only

14 SJM-MEM c Item approved for U.S. use only Case Review: H.S. 75 Year Old Male SJM-MEM c Item approved for U.S. use only Case Review: H.S. 75 Year Old Male SJM-MEM c Item approved for U.S. use only

15 Case Review: H.S. 75 Year Old Male SJM-MEM c Item approved for U.S. use only Case Review: H.S. 75 Year Old Male SJM-MEM c Item approved for U.S. use only Case Review: H.S. 75 Year Old Male No hospitalizations since device implantation Has been reclassified to NYHA class II SJM-MEM c Item approved for U.S. use only

16 Summary Ambulatory PA pressure monitoring is beneficial! Decreases HF hospitalizations Decreases PA pressures Improves quality of life Helps with medication optimization in systolic heart failure May improve survival (more to come) It is safe Patient selection is key NYHA III with HF hospitalization in the past year for commercial implant NYHA II-IV with elevated BNP &/or HF hospitalization in the past year for GUIDE- HF enrollment Need a dedicated team to optimize program success SJM-MEM c Item approved for U.S. use only Questions? SJM-MEM c Item approved for U.S. use only. 47 Extra Slides SJM-MEM c Item approved for U.S. use only

17 Decompensation Events Requiring More Intensive Therapy are Associated with Higher Mortality Risk No Event Intensification of Therapy Emergency Department Visit Heart Failure Hospitalization All Cause Death All decompensation events were associated with a statistically significant increase in mortality risk. Okumura N, et al. Circulation, 2016;133: SJM-MEM c Item approved for U.S. use only CHAMPION Trial: Trial Design 550 w/cmems Implants All Take Daily readings 26 (9.6%) Exited < 6 Months 15 (5.6%) Death 11 (4.0%) Other PA Treatment pressures Arm were managed Control to target Arm goal N=270 N=280 Management pressures Based by on physicians Management with appropriate Based on PA Pressure titration +Traditional of HF Info medications. Traditional Info Only Target Goal PA Pressures: PA Pressure Systolic mmhg Primary Endpoint: rate of HF Hospitalization PA Pressure diastolic 8 20 mmhg PA Pressure mean mmhg Secondary Endpoints: Change in PA Pressure at 6 months No. of patients admitted to hospital for HF Days alive outside of hospital QOL 26 (9.6%) Exited < 6 Months 20 (7.1%) Death 6 (2.2%) Other Abraham WT, et al. Lancet, SJM-MEM c Item approved for U.S. use only CHAMPION Trial: Results: Safety Endpoints Treatment (n = 270) Control (n = 280) P-value Primary Safety Endpoints Device-related or system-related 3 (1%) 3 (1%) complications Total 8 (1%)* < Pressure-sensor failures 0 0 < Secondary Endpoints Change from baseline in PA mean pressure (mean AUC [mm Hg x days]) Number and proportion of patients hospitalized for HF (%) Days alive and out of hospital for HF (mean ± SD) Quality of life (Minnesota Living with Heart Failure Questionnaire, mean ± SD) (20%) 80 (29%) ± ± ± 26 51± * Total of 8 DSRCs including 2 events in Consented not implanted patients (n = 25) Abraham WT, et al. Lancet, SJM-MEM c Item approved for U.S. use only

18 CHAMPION Trial - Sub Group Analysis: Patients with Common HF Comorbidities Comorbidity N size (control) N size (treatment) History of myocardial infarction COPD 2, Pulmonary hypertension AF Chronic Kidney Disease HF Hospitalization rate reduction at 15 months in treatment group 46% (p < vs. control) 41% (p = vs. control) 36% (p = vs. control) 41% (p < vs. control) 42% (p < vs. control) 1. Strickland WL, et al. JACC Criner G, et al. European Respiratory Journal, Martinez F, et al. European Respiratory Journal, 2012 SJM-MEM c Item approved for U.S. use only Benza R, et al. Journal of Cardiac Failure, Miller AB, et al. JACC, Abraham WT, et al. HFSA, Design: Retrospective cohort study based on administrative claims using 100% data from the CMS Standard Analytic File Population (N=1176): Treatment cohort: All fee for service Medicare enrollees undergoing sensor implant (6/2014 3/2016) Control cohort: Matched 1:1 using demographic traits, co-morbidities and timing of HF hospitalization Primary Outcome: All-Cause Mortality & Hospitalizations at 12 months post implant. Clinical match -12 mo Implant 0 12 mo SJM-MEM c Item approved for U.S. use only Clinical Matching N = 1176 N = 1.5 M Hospitalized for HF 1. Gender, Race, ICD or CRT, ESRD, Age ± 5 yrs 2. Co-morbidities: Arrhythmia, HTN, Diabetes, Pulmonary and Renal disease 3. Closest match on propensity score 4. Exact match on HF history: # of HFH and non HFH 5. Closest match on hospitalization timing N = 1087* * N = 89, No matches found SJM-MEM c Item approved for U.S. use only

19 HF Hospitalization: Pre-implant Period Treatment Cohort Control Cohort p-value Number of HF Events NS Avg. LOS days/hfh 5.5 ± ± 4.1 P < 0.01 Total time in hosp. days/pt ± ± 11.4 P = 0.01 Cohort hosp. time days SJM-MEM c Item approved for U.S. use only HF Hospitalization: Post-implant Period HFH/pt-year HFH/pt-year 616 HFH Control Cohort SJM-MEM c Item approved for U.S. use only Subgroups of Interest HF hospitalization Mortality SJM-MEM c Item approved for U.S. use only

20 Selecting patients Champion trial NYHA class III HF admission within the previous 12 months GFR > 25 and diuretic responsive NYHA class III Anyone who gets admitted to the hospital for HF is class 3 or 4 Unable to perform normal activities of daily living without dyspnea or fatigue 6 min walk distance < 400 meters and limited by dyspnea or fatigue KCCQ score ~ SJM-MEM c Item approved for U.S. use only Selecting patients At least one HF admission in the previous 12 months Not a good indicator (in my opinion) If 2 admissions or more in 6 months prognosis may be poor If no admissions in 12 months patients may still derive benefit HF clinics have been designed to rescue patients More ED providers are comfortable with observational stays Hospitalists are being encouraged to reduce LOS and consider observational status SJM-MEM c Item approved for U.S. use only Selecting patients Chronic kidney disease patients GFR is a moving target, consider their baseline Input from Nephrology Are they likely to be on HD in the next year? Diuretic responsiveness What is their total daily diuretic dose? Underlying etiology for the patient s CKD Diabetic or HTN vs. Cardiorenal SJM-MEM c Item approved for U.S. use only

21 COPD CardioMEMS can be very helpful in determining if an exacerbation is due to cardiac or pulmonary etiology COPD exacerbation can cause dyspnea, edema, pulmonary htn Caution FEV1 < 50% Oxygen dependent Evidence of pulmonary fibrosis or interstitial lung disease Consider input from Pulmonology SJM-MEM c Item approved for U.S. use only Patient selection Think twice about Unreliable or noncompliant patients (it doesn t change behavior) Psychiatric illness Nursing home patients Bleeding history (is there a contraindication to anticoagulation or DAPT for a month) SJM-MEM c Item approved for U.S. use only Identifying patients Where do you find them? Hospital HF clinic Cardiology clinic Primary care clinic Hospital Mechanism for notifying your HF providers HF order sets Case managers Hospitalists SJM-MEM c Item approved for U.S. use only

22 Identifying patients Hospital (cont ) HF educators Dieticians HF clinic HF APP awareness/education Hospitalization f/u Rescue therapy vs. inpatient stay Patient awareness (flyers, etc ) 6 minute walk test KCCQ SJM-MEM c Item approved for U.S. use only Identifying patients Cardiology clinic Cardiologist awareness/education Nurse or APP awareness/education Separate diuretic management from ongoing care Hospital service Multidisciplinary HF rounds Patients with a history of HF and have had HF education, HFpEF, Cardiorenal Primary Care clinic / Nephrology clinic CardioMEMS talks Specific referral # for cardiomems Emphasis on safety/ease of implant and improvement in QOL SJM-MEM c Item approved for U.S. use only Patient discussion Be careful on your choice of words! Don t call it a chip A small sensor the size of a dime that will tell us when your heart failure is starting get worse so that we can treat it before your weight starts to go up or you start to get short of breath It is easy and safe to implant (quote complication rate from trial) A large study showed that people with HF and this sensor were much less likely to be hospitalized for worsening HF There are no batteries, and we believe it will last forever New data suggests it may even improve survival (that needs to be proven) SJM-MEM c Item approved for U.S. use only

23 Patient discussion If you send us a pressure reading that is out of the normal range I will get an notification sent to my phone You won t need to weigh yourself anymore Using the sensor will take the guesswork out of managing your HF Driving a car on the highway analogy Small, early adjustments are better in keeping you out of the ditch SJM-MEM c Item approved for U.S. use only